Q3 2023 Astria Therapeutics Inc Earnings Call
Speaker 1: Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties, including those discussed in our most recent Form 10K and our subsequent SEC filings. Such statements may represent our judgment as of today, and we undertake no obligation to publicly update any forward-looking statements except as required by law. I will now pass the call over to Jill Mills, Chief Executive Officer. Jill.
Adults may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties, including those discussed in our most recent Form 10-K, and our subsequent SEC filings such statements represent our judgment as of today and we undertake no obligation to publicly update any forward looking statements, except as required by law I will now pass the call.
All over to Jill Milne, Chief Executive Officer, Jeff.
Good morning, and thank you for joining our earnings call earnings call. We've had an exciting few months at Austria and are in a strong position to close out the year just a few days ago at AC AI annual meeting we shared positive phase <unk> data for Star Zero to one five our lead program that supports our vision for STAAR.
Speaker 2: Good morning and thank you for joining our earnings call.
Speaker 3: We've had an exciting few months at Astria and are in a strong position to close out the year. Just a few days ago at ACAAI annual meeting, we shared positive phase 1A data for STAR0215, our lead program, that supports our vision for STAR0215 to be the first choice preventative treatment for hereditary angiodyma or HAE.
Our 215 to be the first choice preventative treatment for hereditary angioedema or a J E. The data confirm the potential for star 215 to preventive HAE attacks with dosing two or four times per year, we aim to provide patients the option to choose a dosing regimen that works best for their lives.
Speaker 3: The data confirmed the potential for STAR-215 to prevent HAE attacks with dosing two or four times per year.
Speaker 3: We aim to provide patients the option to choose a dosing regimen that works best for their lives, which we will review more on the coming slides. Last month, we also announced the expansion of our pipeline with STAR 310.
Which we will review more on the coming slides.
Last month, we also announced the expansion of our pipeline with Star 310.
Speaker 3: We plan to present a preclinical profile for this program next year with a planned I&D submission by the end of 2024 and phase 1A initiation expected in Q1 2025.
We plan to present, a preclinical profile for this program next year with a planned IND submission by the end of 2024 and phase one initiation expected in Q1 2025.
Our focus for Austria is to develop first choice products that improve the health outcomes of patients with allergic and immunological diseases first choice to us means patients and treating physicians will choose our products because of their strong competitive efficacy low treatment burden and favorable safety and tolerability profile.
Speaker 3: Our focus for Astraea is to develop first choice products that improve the health outcomes of patients with allergic and immunological diseases. First choice to us means patients and treating physicians would choose our products because of their strong competitive efficacy, low treatment burden, and favorable safety and tolerability profile.
Yeah.
Speaker 3: Our initial pipeline is focused on well-established mechanisms, mechanisms that are clinically validated where we believe we can advance ultimately best-in-class programs.
Our initial pipeline is focused on well established mechanisms mechanisms that are clinically validated where we believe we can advance ultimately best in class programs, but very much in line with this strategy is our star 215 program. We think that start to one side is very well positioned to be the first chi.
Speaker 3: Very much in line with this strategy is our STAR 215 program.
Speaker 3: We think that STAR-215 is very well positioned to be the first choice preventative treatment to help stabilize the lives of patients living with HAE, a rare, life-changing, and at times, life-threatening disease.
Joyce preventative treatment to help them realize the lives of patients living with <unk>, a rare life changing and at times life threatening disease.
Speaker 3: STARA310 is an anti-Ox40 antibody, also aligned with this strategy, that we plan to develop as a potential best-in-class therapeutic for atopic dermatitis and potentially other indications.
Started 310 is an anti ox 40 antibody also aligns with the strategy that we plan to develop as a potential best in class therapeutic for atopic dermatitis and potentially other indications.
Speaker 3: The next slide is an overview of our expected milestones for the integrated pipeline with both programs. We just shared additional Phase 1A results at ACAAI this weekend, which further supports STAR 215's best-in-class PK profile and the options for Q3 and Q6 month dosing as a potential HAE preventative therapy with robust attack suppression and low treatment burn.
The next slide is an overview of our expected milestones for the integrated pipeline with both programs.
We just shared additional phase <unk> results at AAC AI This weekend.
Which further supports start to one five best in class PK profile and the options for Q3, and Q six months dosing as a potential H H E preventative therapy with robust attacks depression and low treatment burden.
Our Alpha Star trial in HIV patients is progressing very well.
We are now planning to share meaningful initial proof of concept results in Q1 of 2024.
Speaker 3: Assuming positive results from this trial, we plan to initiate a pivotal phase three trial in Q1 of 2025 and are looking at ways to accelerate this timeline. We are actively working on the design of our phase three trial.
Assuming positive results from this trial, we plan to initiate a pivotal phase III trial in Q1 of 2025 and are looking at ways to accelerate this timeline.
We're actively working on the design of our phase III trial.
Speaker 3: With STAR 310, we expect to submit 9D by year end 2024 and to share the preclinical profile in 2024 at a scientific conference. We anticipate early proof of concept results from a phase 1A trial in Q3 of 2025, which we believe will be an important milestone for the program.
We started three can we expect to submit 90 by year end 2024 and to share the preclinical profile in 2024 at a scientific conference. We anticipate early proof of concept results from a phase <unk> trial in Q3 of 2025, which we believe will be an important milestone for the program.
Speaker 3: Next, assuming positive results in the phase 1a trial, we anticipate initiating a phase 1b clinical trial in atopic dermatitis patients.
Next assuming positive results from the phase <unk> trial, we anticipate initiating a phase <unk> clinical trial in atopic dermatitis patients.
Speaker 3: in the second half of 2025. I will now turn it over to Chris Morabito, our Chief Medical Officer, who will review the new data we have seen for STAR-215. Chris?
In the second half of 2025, I will now turn it over to Chris <unk>, Our Chief Medical Officer, who will review the new data we have seen for starts we went five Chris.
Thanks, Joe.
Speaker 4: STAR-215 is a potential first choice treatment for the prevention of attacks in hereditary angioedema.
Star 215, as a potential first choice treatment for the prevention of attacks in hereditary angioedema.
Speaker 4: HAE is a rare, life-threatening, and life-changing disease characterized by severe, unpredictable, painful, and sometimes life-threatening edema in the skin, abdomen, and airway. Patients with HAE live in fear of having an attack that could be immensely painful or leave them disfigured for several days or, worse, could be fatal.
HIV is a rare life threatening and life changing disease characterized by severe unpredictable painful and sometimes life threatening edema in the scam abdomen and airway patients with ETE live in fear of having of attack that could be immensely painful for leaf.
Disfigured for several days or worse could be fatal.
Speaker 4: For most patients, it's caused by its efficiency in a protein called C1 inhibitor, which is an important component of the body's complement system.
For most patients is caused by a deficiency in a protein called <unk> one inhibitor.
Which is an important component of the body's complement system to.
Speaker 4: Deficient C1 inhibitor may lead to runaway plasmid califrene activity producing bradykinin that causes the painful swelling attacks that characterize AJAE.
Deficiency, one inhibitor may lead to runaway plasma <unk> activity producing brings exciting that causes the painful swelling attack that characterized HIV.
Speaker 4: Star 215 inhibits plasma calcane in order to prevent bradykine release and subsequent swelling, the same mechanism as market leader Taxiro.
Start to one five inhibits plasma Calvert green in order to prevent Brady kind of release and subsequent swelling the same mechanism as market leader <unk>.
Speaker 4: We believe that 215 has the potential to differentiate from currently available therapies, and our goal is to reduce the disease and treatment burden for people living with HAE and help to normalize their lives.
We believe that $2 15 has the potential to differentiate from currently available therapies and our goal is to reduce the disease and treatment burden for people living with HIV and help to normalize their lives.
Speaker 4: STAR-215 is a YTE modified extended half-life monoclonal antibody, which is a trusted modality in HAE. STAR-215 has the potential to support dosing every three and every six months, and we have formulated it to be high concentration and citrate-free for self-administration that may be less painful.
Start to one five is a <unk> modified extended half life, <unk> antibody, which is a trusted modality in HIV.
<unk> five has the potential to support dosing every three and every six months and we have a formulated it to be high concentration and to treat free for self administration that may be less painful.
Speaker 4: As Jill mentioned, we have now shared the results of our Phase 1 Healthy Subject file up through day 2 or 24 days, and these data support our vision for the program. I will now review them in more detail in the coming slides.
As Joe mentioned, we have announced shared the results of our phase one healthy subject trial up through day 224 days and these data support our vision for the program I will now review them in more detail in the coming slides.
The first the phase one trial of 205 is a randomized double blind placebo controlled trial conducted in 41 healthy subjects.
Speaker 4: The FACE1A trial of 2.5 is a randomized, double-blind, placebo-controlled trial conducted in 41 healthy subjects.
Speaker 4: Shown here are the five single-dose cohorts. The results I will share over the next few slides include safety, tolerability, TK, and PD data through the full follow-up period for cohorts one through three and the initial results for cohorts four and five.
So here are the five single dose cohorts the results I will share over the next few slides include safety Tolerability PK and PD data through the full follow up period for cohorts one through three and the initial results for cohorts four and five.
Speaker 4: Ultimately, we are very pleased to see that these results support both every three and every six month dosing strategies for potential HAE preventative therapy with robust attack suppression and low treatment burden.
Ultimately we are very pleased to see that these results support both every three and every six month dosing strategies for potential the HIV preventative therapy with robust attacks depression and low treatment burden.
Speaker 4: On slide 8, we turn to the pharmacokinetic results. In the graph, you can see the rapid and sustained increases in 215. In 600 milligram dose, for example, concentrations above 12 micrograms per mil, the threshold we believe is associated with clinical benefits, were achieved at about 11 hours after the dose was administered.
On slide eight we turn to the pharmacokinetic results in the graph you can see the rapid and sustained increases in <unk> five and six.
<unk> 600 milligram dose for example concentrations over above concentrations above 12 micrograms per 1000, the threshold that we believe are associated with clinical benefits were achieved at about 11 hours. After the dose was administered.
For all of the doses above 100 milligrams concentrations remains above the threshold for clinical benefit for more than 84 days or three months.
Speaker 4: For all of the doses above 100 milligrams, concentrations remained above the threshold for clinical benefit for more than 84 days or three months.
Speaker 4: Based on these data, we estimate the half-life of 215 to be up to 127 days.
Based on these data we estimate the half life of $2 5 million to be up to 102007 days.
Speaker 4: We also saw favorable safety and tolerability with 215 and no serious adverse events of discontinuations due to an adverse event. The most common treatment of adverse events observed were associated with injection site reactions of erythema, pruritus, and swelling.
We also saw favorable safety and Tolerability with 205, and no serious adverse events or discontinuation due to an efforts events. The most common treatment emergent adverse events observed were associated with injection site reactions of erythema pruritus and swelling.
Speaker 4: Here we see our modeling for potential three and six month dosing regimens updated with these newest data. As you see, these results confirm our approach to evaluate administration of 215 every three and every six months.
Here, we see our modeling for.
<unk> potential three and six months dosing regiments updated with these new data.
You're seeing these results confirm our approach to evaluating administration of two five to three and every six months on the left side, we have a simulated three month dosing regimens up against the 600 milligram loading dose on day zero and then followed it up with a 300 milligram dose. Given then every three months we are pleased to see that.
Speaker 4: On the left side, we have a simulated three-month dosing regimen that begins with a 600 milligram loading dose on day zero and then follows it up with a 300 milligram dose given then every three months. We are pleased to see that this dosing regimen can maintain C-Trop levels at about 25 micrograms per mil, well above the 12 microgram per mil threshold associated with prevention of HAE attacks.
This dosing regimen can maintain C trough levels at about 25 micrograms per 1000, well above the 12 micrograms per 1000 threshold associated with the prevention of HIV attacks.
Speaker 4: On the graph on the right, we have a simulated six-month dosing regimen, which begins with a 600 milligram loading dose, and then 600 milligrams every six months, starting 28 days later. Again, we see C-TROC levels that stay well above the 12 microgram per mil threshold, this time at 27 micrograms per mil.
The graph on the right we have accumulated six month dosing regimen, which begins with a 600 milligram loading dose and then 600 milligrams every six months starting 2008 days later again, we see C trough levels that stay well above the 12 micrograms per 1000 threshold. This time about 27 micrograms per 1000.
Based on these results we believe that both of these regimens could be successful in preventing HIV attacks and we will talk more about our dosing strategy on upcoming slides.
Speaker 4: Based on these results, we believe that both of these regimens could be successful in preventing A to E attacks. We will talk more about our dosing strategy on upcoming slides.
On slide 10, we turn to the Pharmacodynamic results. The graph shows the reporter substrate assay in healthy subjects and includes star <unk> data as well as Atlanta della <unk> data acknowledging that these are data from two different healthy subjects single dose cooks clinical trials with.
Speaker 4: On slide 10, we turn to the pharmacodynamic results. The graph shows the reporter substrate assay in healthy subjects and includes STAAR215 data, as well as Landedella map data, acknowledging that these are data from two different healthy subjects, single dose clinical trials.
Speaker 4: With 215, we saw statistically significant inhibition of plastic califene activity observed through day 140 after single doses of 300 and 600 milligrams and through day 224 after single doses of 1,200 milligrams per cube.
With $2 five we saw statistically significant inhibition of <unk> activity observed through day 140. After single doses of 300 to 600 milligrams and through day 224. After a single doses of 200 milligrams per cube.
Speaker 4: The percent inhibition of platelet calocrine is maintained through day 84 after single doses at levels greater than or similar to those achieved by Lanadelumab at peak.
The percent inhibition of plasma <unk> maintained its redeemed 84 after single doses at levels greater than or similar to those achieved by Atlanta della Mab at peak.
Given the promising healthy subject results. We are excited to be studying start two or five patients here's an outline of our Alpha Star trial, which is currently evaluating start to one five in <unk> patients. We're pleased to share that this trial is progressing well and we are currently enrolling into the third cohort.
Speaker 4: Given the promising healthy subject results, we are excited to be studying STAR 215 in HAE patients. Here is an outline of our AlphaSTAR trial, which is currently evaluating STAR 215 in HAE patients. We are pleased to share that this trial is progressing well, and we are currently enrolling into the third cohort.
Speaker 4: We are now planning to share initial proof of concept results in HEE patients in the first quarter of 2024. Assuming positive results from this trial, we expect to initiate pivotal phase 3 trial in Q1 of 2025, and we are looking at strategies to accelerate this timeline.
We are now planning to share initial proof of concept results in <unk> <unk> patients in the first quarter of 2024, assuming positive results from this trial, we expect to initiate pivotal phase III trial in Q1 of 2025, and we are looking at strategies to accelerate this timeline.
Speaker 4: The AlphaSolar Long-Term Open Label Trial is open. Now there are data accruing of participants who have received multiple doses of SARS-215. I will now turn it over to Andrew Cognati, our Chief Commercial Officer, who will review the results of some new market research. Andrew? Thank you, Chris, and good morning, everyone.
Beyond the solar long term open label trial is open now there are data accruing the participants who have received multiple doses to start 205.
I will now turn it over to Andrew community, our clinical our Chief Commercial Officer, who will review the results of some new market research Andrew Thanks, Chris and good morning, everyone.
Speaker 5: Our vision for STAR 0215 is to develop a treatment option that can help normalize the lives of patients with HAE.
Our vision for Star Zero to one five is to develop a treatment option that can help normalize the lives of patients with HIV.
Speaker 5: As Chris mentioned, we've recently completed or conducted some additional market research with both patients and physicians to get a better understanding of the level of interest and enthusiasm around every three and every six month dosing options for STAR 0215.
As Chris mentioned, we've recently completed our conducted some additional market research with both patients and physicians to get a better understanding of the level of interest and enthusiasm around every three and every six month dosing options for star zero to five.
Speaker 5: We presented STAR 0215's profile with both three and six month dosing options to 92 HAE patients and caregivers and 60 HAE treatment providers.
We presented <unk> profile with both three and six month dosing options to 92, eight HIV patients and caregivers and 16 HIV treatment providers.
Speaker 5: On the left graph, you can see that 90% of patients are likely to ask their HCPs about a product with star 0215 profile with every three month dosing, and 97% of HCPs are likely to prescribe.
On the left graph you can see that 90% of patients are likely to ask their hcp's about a product with star zero two <unk> profile with every three months dosing and 97% of Hcp's are likely to prescribe it.
Speaker 5: On the right, you see that 76 percent of patients are likely to ask their prescribers about the profile with every six-month dosing and 93 percent of prescribers are likely prescribers.
On the right you see the 76% of patients are likely to ask their prescribers about the profile with every six month dosing and 93% of prescribers are likely prescribers.
Speaker 5: While the patients and caregivers indicated a slightly higher preference for a three-month dosing regimen, both options indicated a high level of interest from both patients and from prescribers.
While the patients and caregivers indicated a slightly higher higher preference for a three month dosing regimen, both options indicated a high level of interest from both patients.
And from prescribers.
Given the faster development timeline for a three month dosing regimen, we intend to prioritize clinical development for every three months administration, followed by a six month dosing option, enabling patients to choose a regimen that works best for them.
Speaker 5: Given the faster development timeline for a three-month dosing regimen, we intend to prioritize clinical development for every three-month administration, followed by a six-month dosing option, enabling patients to choose a regimen that works best for them.
Speaker 5: So in summary, we're excited about the potential of STAR 0215 becoming a first-choice preventive treatment for HAE patients for the following reasons.
So in summary, we're excited about the potential of star zero two month by becoming the first choice preventative treatment for HIV patients for the following reasons.
Speaker 5: One, as Chris shared earlier, we have compelling data from our 1A trial that supports its potential best-in-class profile. Two, STAR 0215's mechanism of action and modality are proven safe and effective in HAE as demonstrated by the current market leader. Three, STAR 0215 has the potential to provide rapid and durable protection against HAE attacks.
One as Chris shared earlier.
<unk> data from one or 108 trial that supported potential best in class profile to star zero to one five mechanism of action and modality are proven safe and effective in HIV as demonstrated by the current market leader.
Three star zero to one five has the potential to provide rapid and durable protection against HIV attacks.
Speaker 5: For STAR-0215's citric acid-free formulation is expected to reduce injection site pain associated with formulations that contain citric fiber.
Four star Zero 200, fives citric acid free formulation is expected to reduce injection site pain associated with formulations that contains the tree buffers.
Speaker 5: Finally, we plan to develop STAR 0215 in options that support patient choice.
Finally, we plan to develop star zero to one five and options that support of patient choice by.
Speaker 5: by prioritizing development on a three-month dose option first, followed by a six-month dosing regimen.
By prioritizing development on a three months.
Option one.
Followed by a six month dosing regimen.
Speaker 5: We see a very bright future for STAR 0215 as the potential first choice preventative HA therapy, and we look forward to providing you additional updates on our progress next quarter.
We see a very bright future for Istar zero to one five has the potential first choice preventative maintain therapy and we look forward to providing you additional updates on our progress next quarter.
Speaker 6: I'll now turn it over to Andrea Matthews, our Chief Business Officer, who will introduce our STAR 0310 program. Andrea? Thanks, Andrew. Let's turn to our second program, STAR 0310, and a topic for the title.
I'll now turn it over to Andrew Matthews, our Chief business Officer, who will introduce our star zero.
310 program, Andrew Thanks, Andrea Let me turn to our second program with Dr. <unk>, Chen and atopic dermatitis.
Speaker 6: Atopic dermatitis is an immune disorder associated with loss of skin barrier function and itching. It is driven by diverse mechanisms which span the spectrum of T cell driven pathology and it affects approximately five percent of the U.S. population. Half of these cases are reported to be moderate to severe.
It sounds like Durbin guidance, instead of immune disorder associated with elastic skin barrier function at chain.
It is driven by diverse mechanisms, which span the spectrum that T cell phone anthology and it affects approximately 5% of the U S population.
These cases are reported to be moderate from here.
Speaker 6: The burden experienced by moderate to severe atopic dermatitis patients can be significant and can include intense itch, inflamed skin, sleep disruption, depression, and infection.
The Bergman experienced by moderate to severe atopic dermatitis patients can be significant and can include intend to age in place again, please discuss depression infections.
Speaker 6: Here you see psoriasis demonstrates precedent for market growth and evolution for targeted therapies in dermatology.
Here, you see psoriasis demonstrates precedent.
For market growth and evolution of our targeted therapies in dermatology.
Speaker 6: U.S. sales for targeted therapies for psoriasis were approximately a billion dollars in 2010, and that's when there were two drug classes approved, compared to more than 17 billion in 2022, with 15 approved therapies across four major drug classes.
U S sales for targeted therapies for thrive is for approximately $1 billion in 2010, and Thats been there were two <unk> compared to more than $17 million in 2022 with 15 airplanes across four major French platform.
Speaker 6: In atopic dermatitis, there are currently only two approved drug classes for biologic therapies.
Any topic dermatitis. There are currently only two classes for biologic therapies.
Speaker 6: Given the higher prevalence of atopic dermatitis than psoriasis, we and others see that the atopic dermatitis market has even greater potential. We think that the moderate to severe atopic dermatitis treatment market could reach $26 billion by 2030.
Given the higher prevalence of atopic dermatitis, that's right.
I see that the atopic dermatitis market has even greater potential we think that the moderate to severe atopic dermatitis treatment market could reach 26 billion at nine 2013.
Currently depicted as the market leader for targeted atopic dermatitis treatments and our base case assumption is that ox 40 treatments will be after you fix it and the treatment regimen for atopic dermatitis. However, there is good rationale for this to evolve prior to the potential launch of our program in both scenarios. We believe that there is substantial opportunity for stock.
Speaker 6: Currently, Dupixent is the market leader for targeted atopic dermatitis treatments. And our base case assumption is that OX40 treatments will be after Dupixent in the treatment regimen for atopic dermatitis. However, there's good rationale for this to evolve prior to the potential launch of our program. In both scenarios, we believe that there's substantial opportunity for a start.
Speaker 6: I'll now hand the presentation over to Chris, who will review the disease pathology of atopic dermatitis, and also our mission for STAR 310. Chris?
I'll now hand, the presentation over to Craig who will review the disease pathology of atopic dermatitis and also our mission first time III Kevin Craig.
Thank you Andrea.
Speaker 4: Here you can see the immune dysregulation in atopic dermatitis can be complex.
Here you can see the immune dysregulation in atopic dermatitis can be complex.
Speaker 4: Current-approved biologics and other late-stage non-Ox40 biologics target only the Type II pathway, hitting downstream cytokines from Th2 cells.
Current approved biologics and other late stage non ox 40, biologics target only the type two pathway hitting downstream cytokines from th two cells, but <unk> is more complicated than this type one and type three pathways also contribute to this disease starts return as an ox 40 inhibitor, which targets multiple effects.
Speaker 4: But AD is more complicated than this. Type 1 and type 3 pathways also contribute to this disease.
Speaker 4: SARS-V10 is an OX40 inhibitor, which targets multiple infector T cell pathways. It aims to reduce the activity of a broader group of TH cells that are known to contribute to the disease and have the potential to induce higher rates of clinical responses in more patients than currently available biologics and maybe disease modifiers.
T cell pathways that aims to reduce the activity of a broader group of T cells that are known to contribute to the disease and has the potential to induce higher rates of clinical responses in more patients than currently available biologics.
<unk> may be disease modifying.
Speaker 4: Here we do a deeper dive on the AUX40 pathway programs. There are three programs that have achieved a clinical proof of concept, Amlitelemab from Xanthopi, which targets AUX40 ligand, Rofetilamab from Amgen, and Telazolamab, which is the parent program for SARS-B10, both of which target AUX40 on activated T-cells.
Here, we do a deeper dive of the ox 40 private pathway programs. There are three programs that achieved clinical proof of concept <unk> from Santa Fe, which targets ox 40 ligand roughly <unk> from Amgen and tell us all about.
Which is the parent program for startups re tenant both of which target ox 40 on activated T cells.
Speaker 4: All three of these programs have seen promising clinical efficacy results through PHASE-2b in atopic dermatitis.
All three of these programs have seen promising clinical efficacy results through phase II b in atopic dermatitis and.
Speaker 4: And the telomab targets OX40 ligand, which is expressed in a wider array of cell types, which could lead to increased risk for respiratory and vascular adverse events. The tinamab is an epicosylated anti-OX40, which is selected for T cells, but depletes T cells via enhanced ADCC.
<unk> targets X 40, ligand, which is expressed at a wider array of cell types, which could lead to increased risk for respiratory and vascular effort Spence raw potato mab as an equal cost related anti ox 40, which was selected for T cells, but complete T cells <unk> enhance ADC.
Speaker 4: T cell depletion leads to cytokine release and potential increased risk of infection.
T cell depletion leads to cytokine cytokine release and potential increased risk of infection.
Speaker 4: 310 is the next generation of telosorthemab. 310 is designed to have higher affinity, greater potency, and YTE half-life extension technology.
<unk> is a next generation of tellers Northern App <unk> 10 is designed to have higher affinity greater potency and <unk> half life extension technology.
Speaker 4: We believe that 310 has the potential to be the first choice OX40 for moderate to severe B-topic dermatitis. As mentioned on the previous slide, it is designed for a high affinity with selective potency, and we believe that it can match or beat the efficacy seen in other OX40 programs.
We believe that <unk> has the potential to be the first choice ox 40 for moderate to severe atopic dermatitis as mentioned on the previous slide. It is designed for high affinity with selective potency and we believe that it can match or beat the efficacy seen in other ox 40 programs the.
Speaker 4: The half-life of 310 is extended with YTE technology with the goal of reducing the time between doses. And we also believe that we have the potential to administer 310 with subcutaneous delivery.
The half life of 310 is extended with <unk> technology and the Golar.
The goal of reducing the time between doses and we also believe that we that we have.
Potential to administer <unk> subcutaneous delivery and.
Speaker 4: And given that 310 is designed to be T cell preserving with low ADCC, we think it has the potential to have the best in class safety profile.
And given that three tenants designed to be T cell preserving with low ADC. We think it has the potential to have the best in class safety profile.
We have filed a provisional patent application for starts return that if converted granted and Nationalised would prevent would provide patent term extension through 2044 before taking into consideration any potential patent term extensions.
Speaker 4: We have followed a provisional patent application for STAR 310 that, if converted, granted, and nationalized, would provide patent term extension through 2044 before taking into consideration any potential patent term extension.
Speaker 4: As noted, we believe that 310 could be a best-in-class and first-choice treatment for atopic dermatitis.
As noted we believe that <unk> could be a best in class and first towards treatment for atopic dermatitis.
Speaker 4: Starting first with common factors for AUX40 pathway monoclonal antibodies, targeting this pathway has the ability to have disease modifying impacts. The AUX40 pathway has potential for effectiveness across AD driven by multiple effector T cell types, not just Th2. The potential benefit here is robust and sustained responses across a broad range of AD.
Starting first with common factors for ox 40 pathway monoclonal antibodies targeting this pathway has the ability to have disease modifying impacts. The ox 40 pathway has potential for effectiveness across A&D driven across Asia, driven by multiple effector T cell types not just th two.
Potential benefit here is robust and sustained responses across a broad range of BD.
Speaker 4: We also believe that due to the YTE modification, Long-Acting 310 has the potential to be administered four to six times per year compared to the anticipated 12 times per year for Ametilumab and Ropatinumab.
We also believe that due to the <unk> application long Actings III 10 has the potential to be administered four to six times per year compared to the anticipated 12 times per year for <unk> and <unk>.
Speaker 4: We believe the safety profile of a 310 will differentiate from both a ROC that's in the MAP and the TeleMAP as 310 has the potential for reduced T cell depletion due to ADCC and limited potential for AEs due to off-target binding.
We believe the safety profile of <unk> will differentiate from both <unk> and <unk> as <unk> as a potential for reduced T cell depletion due to ADC at limited potential for Aes to off target binding.
Speaker 4: Beyond atopic dermatitis, we believe that targeting the Aux 40 has strong potential and a broad range of additional indications.
Beyond atopic dermatitis, we believe that targeting the ox 40 has strong potential in a broad range of additional indications.
Speaker 5: Noah Klauser, our Chief Financial Officer, will now review our financial information and upcoming milestones. Noah? Thank you, Chris. On this slide, I'll provide a brief summary of important financial information. As of September 30, 2023, we had $188.8 million in cash, cash equivalents, and short-term investments.
Noah Clauser, our Chief Financial Officer will now review, our financial information and upcoming milestones Noah. Thank you Chris.
On this slide I'll provide a brief summary of important financial information.
As of September 32023, we had $188 8 million in cash cash equivalents and short term investments.
Speaker 5: In October 2023, we closed a $64 million underwritten offering. Following the October financing, we expect our cash to support our current operating plan into 2026.
In October 2023, we closed a 64 million underwritten offering.
Following the October financing, we expect our cash to support our current operating plan into 2026. Our current operating plan includes the development of start to one five and start $3 10, including for start to one five support for all program activities up to the initiation of the planned pivotal phase III trial.
Speaker 5: Our current operating plan includes the development of STAR 215 and STAR 310, including, for STAR 215, support for all program activities up to the initiation of the planned Pivotal Phase III trial, and for STAR 310, the anticipated submission of an IND, the planned Phase Ia clinical trial in healthy subjects, and any related anticipated milestone payment.
And for <unk> hundred 10, the anticipated submission of an IND.
<unk> phase <unk> clinical trial in healthy subjects and any related anticipated milestone payments.
Speaker 5: Also illustrated here is a summary of our outstanding equity. In addition to our 36.3 million outstanding common shares, we now have 1.6 million pre-funded warrants and 5.2 million as-converted preferred shares. So in total, we have 43.1 million outstanding common equivalent shares.
Also illustrated here is a summary of our outstanding equity.
In addition to our $36 3 million outstanding common shares we now have $1 6 million pre funded warrants and $5 2 million as converted preferred shares. So in total we have $43 1 million outstanding common equivalent shares for.
Speaker 7: For additional financial information, please see our earnings press release issued earlier this morning and our 10-K, which we plan to file with the SEC after market today.
For additional financial information. Please see our earnings press release issued earlier this morning, and our 10-K, which we plan to file with the SEC aftermarket today.
Speaker 7: I will now touch on upkeep coming milestones and then we will open up for questions.
I will now touch on up keep coming milestones and then we will open up for questions.
Speaker 7: On this slide, you can see the cadence of anticipated milestones, as well as our future development goals for our combined pipeline with at least one clinical milestone each year in the coming years.
On this slide you can see the cadence of anticipated milestones as well as our future development goals for our combined pipeline with at least one clinical milestone each year in the coming years.
Speaker 7: Next year is a big year, as we expect to report proof-of-concept results for STAR 215 inpatients in Q1 and for STAR 310. We plan to submit an IND by year-end.
Next year is a big year as we expect to report proof of concept results for <unk> five in patients in Q1 and for <unk>, We plan to submit an IND by year end. Our ultimate goal is to bring first choice therapies to patients and we're looking forward to executing on that goal in the years to come.
Speaker 7: Our ultimate goal is to bring first choice therapies to patients and we are looking forward to executing on that goal in the years to come.
Speaker 7: I will now ask the operator to open up the line for questions. Thank you.
I will now ask the operator to open up the line for questions. Thank you.
Great at this time, we'll be conducting a question and answer session with our speakers.
Speaker 6: Great. At this time, we'll be conducting a question and answer session with our speakers. Please hold for a brief moment while we pull for questions.
Please hold for a brief moment, while we poll for questions.
So our first question comes from <unk> Yang from Jefferies. Please go ahead.
Speaker 6: So our first question comes from Oon Yang from Jeffries. Please go ahead, Oon.
So when you might be on mute.
Hi, Yes can you hear me okay, yes.
Speaker 8: Oh, yes. Can you hear me? Okay. Yes, we can. Okay. Great. Thank you very much. So.
Yes, we can okay, great. Thank you very much.
Sterno.
Speaker 8: Can you talk about the data in patients that have been accelerated? Can you talk about what I had?
Talk about.
One data.
We maintain insurance or anything else.
Can you talk about what.
Hi.
That accelerate the timeline for the data readout and second question is on thank you.
Speaker 8: to accelerate the timeline for the data readout. And second question is on phase three. I think June mentioned that it's going to start in first quarter 2025, but you are looking into expedite the timeline. So, phase three, do you think a design would be similar?
I think the chairman mentioned that hi, Thank you.
At this time or two.
To go from 25, but you are not allowed to export.
With that what's the timeline for furniture.
Can you think of design.
Speaker 9: to ASL targeting Brachycline from ionist or do you think that you may add an active competitor such as a textile for the efficacy comparison?
Yes.
And Kelly coming from Ireland.
Or do you think about you moving zantac.
Active competitor or participate via <unk>.
Uh huh.
Sure.
Does that efficacy comparison, thank you.
Great, Thanks, John and Chris <unk>.
Speaker 4: Great. Thanks, Yoon, and Chris will address those questions. Yeah, thanks, Yoon. Yeah, we're very excited about the ability to demonstrate some initial proof-of-concept data in patients, and even more excited that the timeline for that has been accelerated now to Q1.
Address next questions, yes. Thank you.
Yes, we're very excited about the ability to demonstrate some initial.
Proof of concept data in patients said, even more excited that the timeline for that has been accelerating now to Q1 and the reason for that is because we've now achieved.
Speaker 4: And the reason for that is because we've now achieved target enrollment in cohorts one and two, and are enrolling into cohort three, and anticipate that we will achieve a planned interim analysis trigger earlier than anticipated.
Target enrollment in cohorts, one and two and are enrolling into cohort three and anticipate that we will achieve.
And a planned interim analysis trigger earlier than anticipated. So the data that we plan to share in Q1 will be <unk>.
Speaker 4: So the data that we plan to share in Q1 will be based on the interim analysis that will trigger in Q1.
<unk> on the interim analysis that will trigger in Q1.
Speaker 4: And as mentioned during the call, aim to provide meaningful POC data.
As mentioned during the call aimed to provide meaningful POC data demonstrating that <unk>, whether its <unk> zero to one five may be effective when given every three months every six months to patients.
Speaker 4: demonstrating that whether STAR 0215 may be effective when given every three months and every six months to patients.
The second question about the phase III design, yes, we are anticipating that the phase III.
Speaker 4: The second question about the phase 3 design, yes, we are anticipating that the phase 3 is in Q1, but we're looking at every opportunity to potentially accelerate that.
<unk> is in Q1, but we're looking at every opportunity to potentially accelerate that.
Speaker 4: We've been doing a lot of work thinking about the design of the phase 3 study. Our current assumption is that it will be a placebo controlled trial, that we will not be versus an active comparator. We also assume that we would have a similar treatment period as other phase 3 trials, which specifically is about 6 months.
We've been doing a lot of work thinking about the design of the phase III study.
Our current assumption is that it will be a placebo controlled trial that we will not be versus an active comparator. We also assumed that we would have a similar treatment period as other phase III trials, which specifically is about six months of treatment period and at the primary endpoint would be similar to what's been used also in phase III study.
Speaker 4: treatment period and that the primary endpoint would be similar to what's been used also in phase 3 studies, which is essentially change from baseline in versus placebo and monthly attack rates.
Which is essentially change from baseline.
Or versus placebo and Luckily attack rates.
Thank you.
Sure.
Thanks for the questions and our next question comes from Samsung lifestyle Capital. Please go ahead Sam.
Speaker 6: Thanks for the question, Zun. Our next question comes from Sam Slutsky at Lifesci Capital. Please go ahead, Sam.
Hey, good morning, everyone. Thanks for the questions and congrats on the updates just two for me I guess for the upcoming Alpha Star interim analysis, given that there is no placebo arm just what data are you looking for that you would consider when before moving to phase III as you think about the different dosing regimens that you might take forward.
Speaker 10: Hey, good morning everyone. Thanks for the questions and congrats on the updates. Just two for me. I guess for the upcoming AlphaSTAR interim analysis, given that there's no placebo arm, just what data are you looking for that you would consider when before moving to phase three as you think about the different dosing regimens that you might take forward?
Yes, Chris.
Yes sure Sam.
So right, we don't have a placebo, but we've built into this the robust running period in which we collect important baseline information on all of our participants.
The planned efficacy analysis is changed from baseline on various efficacy parameters.
To inform the effectiveness of this drug in HLA, specifically, whether a dose can be deferred for three months and the dose could prepare for six months.
Perfect and then just as you think about the quicker enrollment is throwing out the star and right through to phase III.
Speaker 10: Okay, and then just as you think about the quicker enrollment you saw in AlphaSTAR and read through to phase three, anything that stands out, whether it be certain sites you may reuse or just patient feedback in terms of reducing regimens, etc., as we think about timelines for phase three.
Anything that stands out whether it be certain sites you may vary years, or just patient feedback in terms of your dose regimens et cetera.
Thats highlights for phase III.
Speaker 4: Sure. So I think two key things have contributed to the accelerated timelines here. One is the profile. I think that when we talk with physicians, the community, the patients,
Sure. So I think two key things have contributed to the accelerated timelines here. One is about the profile I think that when we talk with physicians the community and to patients.
Speaker 4: Working with our advocacy organizations, you know, we get a lot of frankly positive feedback that the profile is something that is meaningful to patients with this disease.
We're working with our advocacy organizations.
We get a lot of frankly positive feedback that the profile is something that is meaningful to patients with this disease, specifically the ability to administer with such a way that has the potential to potentially normalize the lives of people living with this disease appears to be very attractive and there is interest among.
Speaker 4: specifically the ability to administer in such a way that has the potential to potentially normalize the lives of people living with this disease appears to be very attractive and there is interest among sites and potential participants in joining our development program.
<unk> potential participants in joining our development program and.
Speaker 4: And the second is the trial design. I think we've put a lot of effort into thinking about a clinical trial that would provide meaningful data in a timely fashion. And you pointed out one in question one, which is the lack of a placebo group, which for many is a detriment. So eliminating the placebo group and thinking about dosing regimens that...
And the second is the trial design I think we've had a lot of we've put a lot of effort into thinking about a clinical trial that would provide a meaningful data in a timely fashion.
Pointed at widening question wire, which is the lack of a placebo group which for many.
As a detriment so eliminating the placebo group and thinking about dosing regimens that.
Speaker 4: It could provide important data with limited resource utilization, i.e. sample size. Again, it appears to be attractive to sites and also to patients.
Could provide.
Important data with.
Limited resource utilization Ie sample size again appears to be attractive to site and also to patients.
Awesome. Thank you.
Speaker 11: Thanks for the question, Sam. Our next question comes from Seema Chauran from Evercore. Please go ahead, Seema. Hi. Thank you for taking my questions. My first question is on the proof of concept data that is coming in first quarter. Like, I know the study is small, but what do you think is a win in terms of reduction in HAE attack rates?
Thanks for the question Sam Our next question comes from Cmos Jordan from Evercore. Please go ahead C&I hi, Thank you for taking my questions.
My first question is on that.
Total concept data that is coming in first quarter like I know the study is small but.
What do you think is.
It's a win in terms of reduction in <unk> ataxia.
Just wanted to ask upcoming data readout.
Speaker 11: for this upcoming data readout, and I will call it.
Right.
Speaker 4: Right, so the traditional way of looking at efficacy here is by looking at essentially the monthly attack rates over time. And what has been done in other Phase 1B and 2 trials, you know, is looking at this end point, and there's been between 75 to 100% reductions with small sample sizes at various dose levels.
Right so.
Does it the traditional way of looking at efficacy here is by looking at essentially the monthly attack rates overtime and what has been diving in other phase one and two trials.
Looking at the standpoint.
And theres been between 75% to 100% reductions with small sample sizes.
<unk> dose levels.
Speaker 4: Another way of looking at this is by looking at the proportion of people who are attack free for defined periods of time. For us, that could be after a single dose, looking at proportion of people who are attack free at three months, looking at people who are attack free at six months, and that hasn't been previously reported in any significantly meaningful way. So that's something that, you know, I think would differentiate us in terms of
Another way of looking at this is by looking at the proportion of people who are tax free for defined periods of time for us that could be.
After a single dose looking at proportion of people who are a tax free at three months looking at people who are attack free at six months.
And that Hasnt been previously reported.
And any significantly meaningful way, so that's something that I think would differentiate us in terms of.
Speaker 4: this drug's ability to impact meaningfully the lives of people with this disease. You know, so we'll be looking for a high proportion of people that have, that are attack-free for those predefined periods of time.
This drug's ability to.
Impact meaningfully the lives of people with this disease.
So we'll be looking for a high proportion of people that have.
That are that are attack free for those <unk> to <unk>.
In periods of time.
Speaker 11: That's helpful. Thank you. And also just curious, why there's less interest from docs and patients for six months dosing than three months?
That's helpful. Thank you.
And also just curious why there's less interest from Dawson patients for six months dosing.
<unk>.
Speaker 5: This is Andrew. A couple of comments there as we look through the data. First of all, there potentially could be some perception, as happens with dosing intervals with other products, that you might be losing some levels of efficacy as you extend the dose.
This is Andrew a couple of comments there as we look through the data first of all there potentially could be some perception as happens with dosing intervals with other products that you might be able to you might be losing some levels of efficacy as you extend the dose.
Speaker 5: We don't intend that to happen. We understand that efficacy is an important element of treatment. So our intention is to develop a highly effective treatment for both a three and a six-month dose. So we believe that that might be an issue. The second issue is that the patients that had the six-month dosing option had, obviously, two injections.
We don't intend them to happen, we don't we understand that the that efficacy is.
Important element of treatment. So our intention is to develop.
Of highly effective treatment for both the three to six month dose. So we believe that that might be an issue. The second issue is that the patients that had the six month dosing option had obviously two injections.
Speaker 5: And what quite a few patients, especially with texairo experience, is injection site pain associated with the citrate buffer.
But quite a few patients, especially with tech zero experience is injection site pain associated with the citrate buffer.
Speaker 5: we obviously we're going to be developing a citrate free buffer and we expect to have that level of pain be significantly reduced. So, you know, the numbers are relatively small in terms of the difference. I think the good news for us is that both physicians and patients.
We obviously, we're going to be developing a citrate free buffer and we expect to have that level of pain be significantly reduced. So the numbers are relatively small in terms of the difference I think the good news for US is that both physicians and patients are very excited about both dosing option.
Speaker 5: are very excited about both dosing options. But again, I think if we can demonstrate high efficacy at both doses and have a formulation that reduces injection site pain, I think that those differences could be addressed.
But again I think if we can demonstrate high efficacy of both doses and have a formulation that reduces injection site pain.
I think that those differences.
It could be addressed.
Speaker 11: That's very helpful. Thank you. My last question is on the ADARX data that was presented at ACAI. If you can speak about the read-through from that data for your program.
That's very helpful. Thank you my last question is on the avionics data Douglas presented.
And then if you can speak about Duffy two funds that data for you all program.
And thank you.
Speaker 3: Yeah, so with regard, so yes, so ARX had presented this weekend at ACAI as well as we have, I think, you know, based on the data that we that we saw presented by ARX.
Yeah. So with regard so yes, <unk> had presented this weekend at ECA AI as well as we have I think based on the data that we that we saw presented by <unk>. We do believe that we have a better chance of technical and regulatory success, let's start to one five.
Speaker 3: We do believe that we have a better chance of technical and regulatory success with STAR 215, and that we are more advanced. I think what we learned...
And that we are more advanced I think what we learned.
Speaker 3: over the weekend about their program is that from what we understood, they're currently limited on which dose they can take forward based on safety concerns. And the two mg per kg dose that they are advancing first to patients does not appear that it'll get them through every six months dosing. And so, obviously, you know, lots more information to come from them.
Over the weekend about that program is that from what we understood. There currently limited on which devastate can take forward based on safety concerns and the two make per kg dose that they are advancing first to patients does not appear that it will get them every six months dosing and so obviously lots more information to come from them.
That's helpful. Thank you for taking my questions.
Speaker 6: Thanks for the question, Seema. Our next question comes from Hartosh Singh from Oppenheimer. Please go ahead, Hartosh.
Thanks for the question Cmos. Our next question comes from hard Taj Singh from Oppenheimer. Please go ahead high touch.
Speaker 12: Hey, great. Thank you for a couple of questions and then a really nice presentation. You know, we had done a survey with 25 high prescribing physicians and a lot of Andrew, what you've been saying was kind of, you know, we saw concordance in our survey, but I had just a couple of questions extending from that, you know, from the survey that we did. One was just what are you hearing from pairs? You know, this is a very competitive area. There's a lot of different options, you know, the pair dynamic and the competitiveness is also, I imagine a thing. So, one, what are you hearing from pairs? Or, you know, if you haven't gone there yet, you know, what's the work you're thinking of doing there? Secondly, you know, there still seem to be somewhat of a lack of awareness, you know, there was a core group of our 25 positions that seem to really know two and five very well and others that seem to be sort of, you know, kind of aware of it. How are you going to tackle that?
Great. Thank you for.
Couple of questions and then really nice presentation, we had done a survey with 25 high prescribing physicians and a lot of Andrew what you've been saying was kind of we saw concordance in our survey, but I had just a couple of questions is extending from that.
From the survey that we did one was just what are you hearing from payers. This is a very competitive area.
There's a lot of different options.
The pair dynamics and the competitiveness is also I imagine a thing so one what are you hearing from pairs or.
If you haven't.
Gone there yet.
What's the work Youre thinking of doing there are preparing a secondly, there still seem to be somewhat of a lack of awareness.
There was a core group of our 25 positions that seem to really note two and five very well and others that seem to be so.
Kind of aware of.
How are you going to tackle that.
Speaker 12: And then lastly for Chris just on biomarkers
And then lastly for Chris just on Biomarkers, Chris the Biomarkers, you've been showing us from preclinical and phase one could those in any way help in the phase III trial and coming up with a design that can be fostered. Thank you for the questions.
Speaker 12: You know, the biomarkers you've been showing us from preclinical in phase one, could those in any way help in the phase three trial in coming up with a design that could be faster? Thank you for the question.
Speaker 5: Sure, so we did a bigger landscape assessment earlier this year and what we learned is that at least right now.
Sure. So we did a land of payer landscape assessment and earlier this year.
And what we've learned is that at least right now.
Speaker 5: Ultimately, patients can get the product that physicians will prescribe in HAE, but over... the class is going to continue to be managed. So, you know, I think like in other rare diseases, there might be some work associated with getting patients onto the treatment that they want, but generally...
Ultimately patients can get the product that physicians will prescribe.
In a JV, but over the.
The class is going to continue to be managed so.
Things like and other rare diseases.
There might be some work associated with getting patients onto the treatment that they want but generally.
You can get there, but again.
Speaker 5: you can get there. But again, the class will continue to be managed more actively as more treatments become available.
The class will continue to be managed more actively as more treatments become available.
Speaker 5: The other thing that we heard is that efficacy continues to be a very important element of what the payers are looking for.
The other thing that we heard is that efficacy.
<unk> continues to be a very important element of.
What the payers are looking for so again, given the profile that we're looking to develop we're looking to develop a treatment.
Speaker 5: So again, given the profile that we're looking to develop, we're looking to develop a treatment that hopefully can provide comparable efficacy in terms of attack rate reduction. There's an opportunity for us to keep even more patients attack free, but then also combine that with a product that patients obviously would be more compliant with. So that's what we're learning from the payers in the U.S.
Hopefully can provide comparable efficacy in terms of the cap rate reduction.
There is an opportunity for us to keep even more patients attack free.
But then also combine that with a product that patients.
Honestly would be more compliant with so so that's what we're learning from the payers.
In the U S.
Speaker 5: I would say that from an awareness perspective, obviously, we're generating additional data that we're going to continue to share at conferences. We are
Would say that from an awareness perspective, obviously, we're generating additional data that we're going to continue to share at conferences.
We are.
Speaker 5: uh, creating a medical affairs function, and we started that process, uh, earlier this year. We're looking to grow that. So, you know, I think that our awareness amongst, uh,
Creating a medical affairs function that we started that process earlier. This year, we're looking to grow that so I would say.
Our awareness amongst.
Top one kols is very high.
Speaker 5: Top one KOLs is very high. I think our awareness within the HAE community continues to grow. But I do believe that we'll continue to publish, hopefully very impressive, encouraging data that both physicians and patients will be interested in. And as we continue to grow our organization, hopefully we can increase that share of voice within the community.
Our awareness within DHA community continues to grow.
I do believe that we'll continue to publish hopefully very impressive encouraging data that both physicians and patients will be interested in and as we continue to grow an organization hopefully we can increase that share of voice within the community.
Speaker 4: And the hard times regarding biomarkers. The biomarkers that we and others use in this space are useful for target engagement, but don't, I think, get up to the level of surrogacy. So I think we'll be able to use PD to inform the potential data set that we'll bring to regulators, but not rely on it.
And the hard times regarding the Biomarkers, the biomarkers that we and others use in this space are useful for our engagement, but don't I think get up to the level of surrogacy. So.
We will be able to use PD for.
For the potential of.
The dataset that will bring to regulators, but not rely on it.
Speaker 4: You know, as I mentioned before in other meetings that we've had, I think PK is a meeting that we've had here in investor settings, the PK itself, I think, is a stronger supporter of potential effectiveness.
As I mentioned before in other meetings that we've had I think teekay is both meetings that we've had here.
Mr settings.
The PK itself I think is the stronger.
Supporter of potential effectiveness, we targeted 12 micrograms per 1000 as asset threshold, we believe confirms the potential for effectiveness. So we've been looking very closely at that we will be looking obviously at PK in patients in our phase III trial, so PK and PD.
Speaker 4: We target 12 micrograms per mil as the threshold we believe confers the potential for effectiveness.
Speaker 4: So we've been looking very closely at that. We will be looking, obviously, at PK in patients in our phase three trial. So PK and PD will support, but I don't think replace, the data set we'll be able to use for phase three.
Support, but I don't think replace the.
The data set will be able to use for fixed rate.
Great. Thank you for all the questions.
Speaker 13: Thanks for the questions, Haritaj. Our next question comes from Joe Pangenis from H.C. Wainwright. Please go ahead, Joe.
Thanks for the questions for Tosh. Our next question comes from Joe <unk> from H C. Wainwright.
Please go ahead Jim.
Joe are you there.
Okay. We will go to the next analyst until Jan is able to connect.
Speaker 13: So our next question comes from Ingrid Reichermeyer from Wedbush. Please go ahead, Ingrid.
So our next question comes from Ingrid. Thank your minor from Wedbush. Please go ahead and grid.
Do you think you might be on mute.
And grade are you on mute.
To the audience, please give us a second.
Yeah.
So our next question comes from Farhan Issaquah from Ladenburg. Please mute your line on mute your line.
Speaker 6: So, our next question comes from Farhana Sackloff from Lattinburg, please mute your line, unmute your line.
Speaker 14: Hi, good morning. This is Farhana on behalf of Michael. Firstly, congrats on the quarter. As most of our questions, you know, have been asked, we will just follow up on one. You guys said that the phase 2, I mean, sorry, the phase 1B was enrolling faster because there was no placebo arm. For the phase 3, if I heard correctly, for the design, there is going to be a placebo arm. So do you see that there will be an impact on enrollment?
Hi, good morning, the Susquehanna on behalf of myself, Patrick on that on the quarter.
As most of our questions.
So I would just follow up on one.
You guys said that the first two I mean, sorry, the phase one b with enrolling hospital, because there was no placebo arm.
For the phase III, if I heard correctly, but the design there is gonna be a placebo arm suggests you've got there would be an impact on enrollment.
I do think that there will be an impact on enrollment, but I think that we'll be able to mitigate it for.
Speaker 4: I do think that there will be an impact on enrollment, but I think that we'll be able to mitigate it with a variety of factors, including ideally strong proof-of-concept data that will continue to support the profile and raise awareness among sites.
With a variety of factors, including.
Ideally strong proof of concept data that will continue to support the profile and raise awareness amongst sites.
Speaker 4: We have intentions of making this a global trial as well, which will increase the opportunity for patients around the world to experience 215 and also to contribute to our data set.
We all have intentions of making us a global trial, as well, which will increase the opportunity for patients around the world to experience two and five and also to contribute to our dataset.
Speaker 4: And we've been working very closely with the community, and not just...
And we.
We've been working very closely with the community and not just.
Speaker 4: talking about the profile, but also in the development of this medicine, and I think we all already have strong support from the community demonstrated by the enrollment that we've talked about with 215 and ideally that support will translate into support for Phase 3 and enrollment into the trial in Phase 3.
Talking about the profile, but also in the development of this medicine.
I think we all already have strong support from the community demonstrated by the enrollment that we've talked about with $2 five and ideally that that support will translate into support for phase III in enrollment.
The trial in phase three.
Thank you.
Thanks for the question Farzana. Our next question comes from Joe <unk> from H C. Wainwright. Please go ahead Kevin.
Speaker 6: Thanks for the questions, Verona. Our next question comes from Joe Pangenis from H.C. Wainwright. Please go ahead, Joe.
Speaker 15: Hey, everybody. Sorry about that. That was Murphy's Law of connectivity issue timing, but appreciate the getting back in. So, my question is also on the Phase 3. I guess I'll ask it this way. Your goal is to accelerate the timing that you talked about. What do you consider the rate-limiting steps? I mean, there's a lot going on over the next several months. Do you need to be able to get to more solar OLE data, additional follow-up across the board, what kind of logistics, design, regulatory discussions, and CMC? I basically listed a lot there, but what do you think are the rate-limiting?
Everybody sorry about that that was a murphy's law of connectivity issue timing.
But I appreciate the getting back in so my question is also on the phase III.
I guess I'll ask it this way your goals to accelerate the timing that you talked about what do you consider the rate limiting steps I mean, there's a lot going on over the next several months.
You need to be able to get to more solar OLED data additional follow up across the board you know what kind of logistics design.
Regulatory discussion then CMT I basically lifted a lot there, but what do you think are the rate limiting steps.
Speaker 4: So you answered the question yourself. I think you've outlined all of the things that we have to think about as we think about the plan for the start of the Phase 3. And without knowing the data, it's difficult for me to identify what factor could be contributing as a critical path or rate limiting.
So you answered the question yourself I think you've outlined.
The things that we have to think about as we think about the plan for <unk>.
The startup of phase III.
Knowing the data of its difficult for me to identify what factor could be contributing.
Critical path or rate limiting.
Speaker 4: Just to repeat what you said, after we get the data, we need to analyze them, understand them, and finalize the approach for phase three. We need to get regulatory input from not just the U.S., but around the world. As I mentioned, we plan to make this a global trial.
Just to repeat what you said after we get the data we need to analyze them understand them.
Finalize the approach for phase III, and we need to get regulatory input from not just the U S. But around the world as I mentioned as we plan to make this a global trial.
Speaker 4: Obviously, we're making drugs, thinking that we're going to continue dosing people with this disease, so hopefully CMC doesn't impact timelines too much, but we'll have to do some work on dose selection, which can impact the timing for.
Obviously, we're making driving thinking.
We're going to continue dosing people with this disease, so hopefully C&C.
Does it does it impact highlights too much above a lot to do some work on dose selection, which can impact timing for four during before the start of a phase III. So we're going to be looking very deeply at all of those steps and as mentioned before we look for opportunities to accelerate and when we share the update with the Q1 data.
Speaker 4: for the start of the phase three. So we're going to be looking very deeply at all of those steps. And as mentioned before, look for opportunities to accelerate.
Speaker 4: And when we share the updates with the Q1 data, we anticipate being able to share a more robust timeline to phase three as well as the phase three trial itself. Appreciate the call.
We anticipate being able to share a more robust timeline to phase III as well as the phase three trial Astellas.
I appreciate the color. Thanks.
Speaker 6: Thanks for the questions Joe. Our final question comes from Ingrid Reitschermeier from Wedbush. Please go ahead Ingrid. Hi this is Ingrid.
Thanks for the questions Joe Our final question comes from Ingrid breakthrough minor from Wedbush. Please go ahead and grant.
Hi, this is anchored on for Laura Chico.
Speaker 16: Just any color of the baseline characteristics you can share at this time of the patients you have enrolled.
Just any color on the baseline characteristics you can share at this time of the patients you have enrolled in the Alpha Star trial, I'm, just trying to get a sense.
Speaker 16: in the AlphaSTAR trial, just trying to get a sense of demographics, if you can share that. Thank you.
Hi, demographics, if you can share that yes I can.
Speaker 4: Yeah, I can't, I can't share the specifics about the demographics at this point, but I can tell you that the inclusion and exclusion criteria of our trial are very similar to what's been done in other diseases in the space. And in fact, we designed ours based on.
Sure the specifics about the demographics at this point.
But I can tell you that the inclusion and exclusion criteria of our trial are very similar to what's been done.
Other diseases in this space.
In fact, we decided to hours based on other trials. So we would anticipate a similar set of baseline demographics in terms of the severity of the disease.
Speaker 4: other trials, but we would anticipate a similar set of baseline demographics in terms of the severity of the disease.
Speaker 4: and background or history of medication use has been demonstrated with other trials. I can tell you that we've been up, as you well know from clinicaltrials.gov, we've been up in the U.S. and Canada, so the data will be limited to patients from U.S. and Canada.
And background.
Our history of medication use as been demonstrated with other trials.
Can tell you that we've been as you will know from clinical trial site.
Gov, we've been up in the U S and Canada. So the data will be limited to patients from U S and Canada.
Thank you.
Thanks for the question Ingrid.
Speaker 6: This concludes today's Q&A session. I'll now turn the call back over to Jill.
This concludes today's Q&A session I'll now turn the call back over to Jill.
Speaker 3: Thank you, operator. Thank you all for joining our call this morning and for your continued support of Astrea. We'll keep you updated as we execute on our STAR 215 program, the AlphaSTAR trial, and share other areas of progress at the company, including our STAR 310 program. We look forward to speaking with you again soon. Liz.
Thank you operator, and thank you all for joining our call. This morning and for your continued support of Austria, We will keep you updated as we execute on our start to five programs. The Alpha star trial and share other areas of progress at the company, including our Star <unk> program. We look forward to speaking with you again soon.
Speaker 1: That concludes today's call. A webcast replay will be available for 90 days via the Investor Relations page on our website at www.astriatx.com. Thank you.
That concludes today's call and webcast replay will be available for 90 days via the Investor Relations page on our website at Www Dot <unk> Dot com. Thank you.
Speaker 17: ?Outro Music?
[music].
Sure.
Sure.
[music].
Yeah.
Okay.
Hum.
Yes.