Q4 2022 Astria Therapeutics Inc Earnings Call
Speaker 1: attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Astria Therapeutics website for 90 days following the conclusion of the event.
Speaker 1: I'd now like to turn the call over to Andrea Matthews, Senior Vice President of Corporate Affairs at Astrea Therapeutics. Please go ahead, Andrea.
Speaker 1: Thank you operator. Welcome to today's AFTIR Therapeutics conference call where we will provide a corporate update and review our fourth quarter and full year 2022 financial results. With me today are Jill Milne, Chief Executive Officer, Andy Nichols, Chief Scientific Officer, Andrew Comiotti, Chief Commercial Officer, Chris Moravito, Chief Medical Officer, and Noah
Speaker 1: of the investors part of our website.
Speaker 1: I would like to note that during today's call, as mentioned on slide two, we will make forward-looking statements related to our business based on current and future expectations that may be considered
Speaker 1: Actual results may differ from those indicated, including those discussed in our most recent annual report on Form 10-K , as well as discussions of potential risks, uncertainties, and other important factors in subsequent SEC filings, which will be available on our website. Such statements represent our judgment as of today, and AASTA undertakes no obligation to publicly update any further decisions.
Speaker 1: update. Jill will then take that. Thank you Andrea. Good morning everyone and thank you for joining us on today's call. Starting on slide three at Astraea, patients are our guiding stars. We were fortunate to be able to hear firsthand from patients living with HAE about their experiences with the disease.
Speaker 2: and their hopes for the future during our first ever STAR0215 day last month, as you might expect on February 15.
Speaker 2: Jasmine, shown here, shared with us her hope to live a life without the burden of frequently administered treatment. Our goal is to fulfill her vision with a product like STAR0215.
Speaker 2: Moving to slide four, Jasmine's hopes echo what we have heard from the HAE community, the desire to live without limitations from their symptoms and treatments. Our vision for STAR 0215 is to become the first choice preventative treatment for HAE with administration every three or six months.
Speaker 2: with the goal of normalizing the lives of people living with HAE like Jasmine. We believe that by reducing both treatment and disease burden, we can allow patients to focus their time and energy on what matters most to them.
Speaker 2: Turning to slide five, here is our plan star 0215 early development strategy to execute on this vision. We believe that the HAE treatment paradigm can be transformed with a highly effective every three months preventative treatment.
Speaker 2: like our target profile for STAR0215. We were able to check the first box here regarding safety, PK, and PD in healthy subjects with the positive results from the Phase 1A trial. We will go into more detail about these results today. We also see strong interest in the treatment with this profile from both patients.
Speaker 2: trial in more detail.
Speaker 2: Turning to the right-hand side of the slide, we are also exploring a six-month dosing interval for STAR0215 as a potential additional option for patients.
Speaker 2: Additional cohorts in the Phase 1A trial are assessing six-month dosing.
Speaker 2: Initial results are expected in the fourth quarter of this year. The ELFAS STAR trial design includes the opportunity to gain initial information on six months safety and efficacy in HAE patients, and we are learning more about patient and physician interest in a product with this potential profile.
Speaker 2: Moving on to slide six, 2022 was a pivotal year for Astrea as we progressed our mission to bring life-changing therapies to patients and families impacted by HAE and rare and niche allergic and immunological diseases.
Speaker 2: Here are the three main points that I would like to emphasize for today's call.
Speaker 2: We brought STAR0215 into the clinic and shared positive results from our Phase 1a clinical trial in December . The Phase 1b2 alpha star trial in people living with HAE is underway with initial proof of concept results expected in mid-2024.
Speaker 2: Additionally, we are well funded to achieve our goals with the closing of an underwritten offering of common stock with gross proceeds of approximately $150 million in December , bringing our expected cash runway through the first half of 2025 based on our current operating plan.
Speaker 2: I will now hand the call over to Andrew to talk about the market opportunity. Andrew? Thanks Jill. So shown on slide 7, the AHA treatment market is substantial and it's growing.
Speaker 3: The global HAE market was well over 2 billion dollars in 2022 and is expected to grow to 4.2 billion dollars by 2028.
Speaker 3: This growth is expected to be driven by patients being diagnosed earlier, more patients opting for treatments to prevent HAD attacks, and the expansion of available therapies in more geographic regions.
Speaker 3: While there are several preventative treatments currently available and in development, we believe that the profile of STAR0215 as an effective monoclonal antibody plasma calorificine inhibitor dose every three months or less frequently can address the unmet need in this market.
Speaker 3: and become a leading treatment option for HAE patients.
Speaker 3: Turning to slide A, we recently completed a quantitative market research study with over 100 HAE patients where we asked them their willingness to try a product profile like star 0215.
Speaker 3: As you can see on the graph to the left, all survey patients indicated that they were willing to try a product with this profile and close to 70% being very willing to either start or switch to a product with this profile.
Speaker 3: These results include patients either on Orlodio, the only current oral treatment available, and those on a monthly dosing regimen of Taxiro, also known as Lanadilumab, and the current market leader, although most patients are on the every two week regimen.
Speaker 3: We've also conducted research with HAE prescribers who also expressed a very strong willingness to prescribe a treatment with STAR0215 potential profile and suggested STAR0215 would gain strong patient share in a future HAE market.
Speaker 3: And that's what really excites us with bringing this treatment to the HAE community.
Speaker 3: I'll now hand it over to Andy to speak about star 021's profile. Andy? Okay.
Speaker 4: Thanks Andrew, good morning everyone. So turn into slide 9.
Speaker 4: STUM 0215 was designed with the vision of normalizing the lives of people living with HAE.
Speaker 4: The goals of our program are twofold. First, to generate a high potency antibody that could inhibit plasma chamomile to the same levels as lanadelumab.
Speaker 4: second to engineer an antibody with a long circulating half-life with the potential to prevent HAE attacks with dosing once every three months or even less frequently.
Speaker 4: We've demonstrated that STUH0215 allosterically binds to a unique site of plasma calacrine to produce potent and selective inhibition of plasma calacrine activity.
Speaker 4: Style 0215 includes YTD modifications in the FC domain specifically to extend its half-life.
Speaker 4: The high concentration of our formulation and lack of citric acid enables patient-friendly subcutaneous dosing of Stave 0215 with the goal of significantly less injection site pain to patients compared with linaldelimat. I'll now hand it over to Chris to go through the Phase 1a clinical trial. Chris? Thank you Andy and good morning everyone.
Speaker 3: Moving to slide 10, we are pleased to review initial data from the Phase 1A trial of STAR0215 that were recently presented at the Quad AI meeting in February of this year. This is a randomized, double-blind, placebo-controlled trial of single, eight sending doses in healthy adult subjects. This is a randomized, double-blind, placebo-controlled trial of single, eight sending doses in healthy adult subjects. This is a randomized, double-blind, placebo-controlled trial of single, eight sending doses in healthy adult subjects.
Speaker 3: We have results from the first three cohorts through three months of the approximately eight month total follow-up.
Speaker 3: We have added two additional cohorts to the phase 1a trial and healthy subjects to explore the potential of administering STAR0215 every six months.
Speaker 3: Co-ords 4 and 5 have single doses of 1200 mg subcutaneous and 600 mg IV respectively.
Speaker 3: Initial results from these additional cohorts and final results from the first three cohorts are expected in fourth quarter of this year.
Speaker 3: Turning to slide 11.
Speaker 3: These initial data suggest that STAR0215 is well tolerated and has a favorable safety profile. In total, there were eight subjects with related treatment and virgin adverse events, seven receiving STAR0215, and one receiving placebo.
Speaker 3: All treatment-aversion adverse events were mild and resolved. There were no moderate, severe, or serious adverse events. There were six subjects with injection site reactions, all in subjects receiving SARS-0215. The most common injection site reaction was injection site redness.
Speaker 3: There were no reports of injection associated pain. As noted, these were all mild and resolved without sequillia.
Speaker 3: For perspective, the most commonly reported adverse reactions associated with lanodelumab are injection site reactions, most commonly pain, upper respiratory tract infection, and headache. More than half of lanodelumab treated subjects reported injection site reactions with administrations during the phase III trial. Lastly, no treatment of urgent anti-drug antibodies were detected with star 0215.
Speaker 3: Subcutaneously. Note that the profiles show rapid and sustained concentrations over time after single subcutaneous doses and that the concentrations are proportional to dose.
Speaker 3: You can see visually that the elimination phase is long. This long elimination phase is a result of the YTE modification which is designed to prolong half-life by slowing down drug clearance.
Speaker 3: Based on these data, the estimated half-life of star 0215 is up to 117 days.
Speaker 3: Importantly, the 300 milligram and 600 milligram profiles show durable concentrations at and above levels we believe to be consistent with clinical benefit for at least three months. Andy will now walk through our pharmacodynamic data that support this with results consistent with levels associated with clinical benefit. Andy?
Speaker 4: Thanks, Grace.
Speaker 4: So on slide 13, you can see that we assess the pharmacodynamic activity of STARS 0215 by measuring the functional inhibition of plasma calacrine using assays that are similar to those used by DIACs in phase 1 of LAD and LMAB in healthy volunteers.
Speaker 4: which allowed them to predict doses that would be effective in producing HADSX.
Speaker 4: In healthy adult subjects, plasma calorimetry levels very low.
Speaker 4: So in order to mimic what happens during an HEE attack, we stimulated the production of plasma calacrine ex vivo.
Speaker 4: by adding factor 12a to samples taken from the subjects before and various time points after dosing.
Speaker 4: The plasma calacrine that is produced cleaves its natural substrate, high molecular weight kinogen that is present in the plasma.
Speaker 4: And we used the Western Blot assay technique to measure this cleavage of high molecular weight kinetrogen.
Speaker 4: As we remind them, using this technique, lana-delimab at 3 mg per kg, or approximately 250 mg, produced about a 50% reduction in factor 12a activated cleave high molecular weight kinetagen in healthy volunteers.
Speaker 4: In addition, we also assessed the inhibition of plasma calacrine activity using a peptide substrate reporter assay in which we look at the cleavage of a small 3 amino acid peptide that we add to the plasma.
Speaker 4: Using this assay format, lidodilumab at the approximately 250 mg dose in healthy volunteers inhibited factor 12a activated plasma calacrine activity by about 40% and this effect was lost 40 days after dosing. On slide 14 we show that star 0215 inhibited plasma calacrine activity is a result of a
Speaker 4: the effect is sustained for a substantially longer period of time compared with Landa Delibet.
Speaker 4: Importantly, the level of activity observed through STAR-0QSA is consistent with the level of inhibition of plasma chalacrite shown to prevent HAE attacks with lantodilumab.
Speaker 4: I'll now hand it back to Chris to review the design of our ongoing clinical trial in HEE patients.
Speaker 3: Outline on slide 15, Alpha Star is a dose-ranging, proof-of-concept trial assessing the potential effectiveness of star 0215 in long-term prevention of ATE attacks.
Speaker 3: This trial is assessing the effects of single and multiple doses of STAR0215 in people living with ATE due to C1 inhibitor deficiency.
Speaker 3: As a dose-ranging proof-of-concept trial, the results, if positive, would show robust and durable protection against ATE attacks and inform on dose regimens that may be tested in future trials. southerngaterese.org
Speaker 3: All qualifying participants will receive STAR 0215.
Speaker 3: Initial proof of concept data are expected in mid-2024. As shown here, we are planning to amend the trial to add a new cohort, labeled here as cohort 3, that would assess the effects of a subcutaneous dose regimen that targets high initial concentrations of STAR0215 andlu reos por
Speaker 3: and that we anticipate would maintain plasma calicrine inhibitory concentrations consistent with clinical benefit for six months.
Speaker 3: Results from this cohort, if positive, would assist in dose selection of STAR0215 for potential administration every six months.
Speaker 3: The other two cohorts will remain the same with the exception that part of the sample size from cohort 2 would be reallocated to cohort 3.
Speaker 3: While we continue to target enrolling up to 18 subjects, we plan to add flexibility to enroll more participants to cohorts if needed. Cohort 1 remains a single dose cohort, administering 450 mg once in people with HAE and following the clinical effects out through six months.
Speaker 3: Cohort 2 is a multiple dose cohort testing a loading dose of 600 milligrams followed by a maintenance dose of 300 milligrams given three months later. Participants are followed through to six months after the 300 milligram dose.
Speaker 3: We anticipate that the effects on HEE attack reduction in people enrolled in these first two cohorts may last for three months or longer.
Speaker 3: The cohort 3 has two initial 600 milligram doses given one month apart with participants in follow up for six months after the second dose.
Speaker 3: Given the PK and PD profile demonstrated in healthy human subjects, it's possible that the clinical results from a dose regimen that targets these anticipated concentrations may endure for six months.
Speaker 3: The invoice for the trial, including safety, attack rate changes, PK, and PD remain the same.
Speaker 3: So far, the trial has initiated in the US and Canada, and we're actively bringing patients into the trial. And we're on track to initiate in Europe , including the UK, mid-year, assuming receipt of regulatory approvals.
Speaker 3: Data are expected in mid-2024 and are anticipated to include initial results from all three cohorts. The goal is to show significant reduction in ATD attacks following STAR0215 treatment. We expect these data, if positive, will help us refine our approach to establishing the effectiveness of STAR-
Speaker 3: is anticipated to enroll participants from AlphaStar and is expected to start later this year in time for the initial completers of the AlphaStar trial to enroll. We expect this trial to evaluate primarily safety as well as effects on each attack and quality of life.
Speaker 3: I will now turn it over to Noah to provide a financial update. Thanks, Chris, and good morning everyone. Turning to slide 16, I'll provide a brief summary of important financial information. In December 2022, we closed a $115 million underwritten offering of common stock. As of December 31, 2022, we had cash, cash equivalents, and cash equivalents.
Speaker 3: million for the fourth quarter of 2022, or 72 cents per share, and $51.8 million for the full year 2022, or $3.55 per share. As of December 31st, we had approximately 27.5 million common shares outstanding.
Speaker 2: and approximately 33.2 million common equivalent shares outstanding when including our outstanding convertible preferred shares on an as-converted basis.
Speaker 3: For additional financial information, please see our earnings press release and our 10k, which we plan to file with the SEC aftermarket today.
Speaker 2: Jill will now review our upcoming milestones and then open the call for questions. Jill? Thank you, Noah. In summary on slide 17, we were thrilled that STAR0215 has shown early proof of concept in the Phase 1A trial for its target profiles, a long-acting preventative therapy for HAE, a best-in-class PK profile, and a
Speaker 2: and dosing every three months or less frequently. We also believe there could be an opportunity to dose STAR0215 every six months and we are evaluating this with cohorts added to our ongoing Phase 1a and AlphaSTAR trials. Looking to our upcoming milestones, we expect preliminary results from the additional cohorts and healthy subjects as well as
Speaker 2: Additionally, we will plan...
Speaker 2: to initiate a long-term open label trial in the second half of this year. As we think about the future, we are excited about the potential for STAR0215 to provide long-acting, effective attack prevention for people living with HAE.
Speaker 2: Turning to slide 18, here we see Jasmine again, this time with Kim, Melissa, and Melissa's daughter Hannah, all living with HAE from when they joined us at our offices last month. Speaking with the HAE patient community to better understand their lives and needs guides all that we do in Astria.
Speaker 2: And we are so thankful to Jasmine, Kim, Melissa, and Hannah for sharing their experiences with us.
Speaker 2: We are charting a new path for HAE patients, one that envisions an opportunity for a better quality of life with a long-acting preventative therapy that has meaningful efficacy within frequent dosing and can fulfill the vision of normalcy that these four patients express.
Speaker 2: Lastly, on slide 19, to recap, 2022 was a pivotal year for Astraea as we progressed STAR 0215 into the clinic and shared positive results from our Phase 1a clinical trial in December . The Phase 1b2 alpha star trial is enrolling HAE patients and we anticipate proof of concept.
Speaker 2: star 0215 as we aim to allow patients to focus their time and energy on what matters most to them. With that, I'll ask the operator to open up the call for your questions. Operator, can you please repeat the instructions and hold for questions? Thank you.
Speaker 1: Great, at this time, we'll be conducting a question and answer session with our speakers.
Speaker 1: Please hold for a brief moment while we pull for questions.
Speaker 5: Noi.
Speaker 1: So our first question comes from Hartaj Singh from Oppenheimer. Please go ahead Hartaj.
Speaker 6: Great. Thank you. I've got a couple of questions. So I'll just ask one. They're a little different. So I'll just ask one and then follow up with the second one. You talked about the YT modification to the antibody and the lack of citrate. So is there kind of getting into
Speaker 6: extended follow-up with patients. So, I just want to ask Andy about, you know, historically, you have YT modifications over the long term, you know, produce some side effects that you're watching out for, just anything untoward or not. And again, great presentation on all the data, which I didn't say earlier. So, thank you. Thanks, accelerated, preferenc accountant.
Speaker 4: So of the YTE modified antibodies that have been studied in the clinic, there have been no specific reports of any safety issues associated with the YTE. Recall it has actually been studied quite extensively in the context of the Servimab, the anti-RSV antibody.
Speaker 4: for prevention of COVID-19 in high risk individuals. And there has been no reported safety issues associated with those antibodies that would lead us to have any concerns about the YTE specifically. Great, thank you, Andy. And then I got a question just on the commercial side.
Speaker 6: What we're hearing from companies that we cover and then just others is that subtly the HAE market is kind of shifting over to a prophylaxis market. It used to be less than 50% prophylaxis and now is getting close to two-thirds prophylaxis and could increase even to...
Speaker 6: you know, maybe 80% and then with the orals being introduced, there are more and more patients potentially taking, you know, being on medication. How do you see, you know, in the future? Two and five. I know it's early days. Do you really think it's more, you know, competes against other injectables or do you think the orals, which are still looks like one to
Speaker 6: day and probably will stay there, that they will be fair games also, you know, assuming that three month profile may be even up to six months. Thank you for the questions.
Speaker 7: I can take that. Good morning.
Speaker 7: So a couple of comments. You're absolutely right, the preventative market in the US, about two-thirds of patients are on a preventative treatment. That percentage is slightly lower or lower in Europe , closer to 40-45%. So we do believe that the market will continue to grow with the emergence of new treatments.
Speaker 7: However, you know, as I mentioned earlier in the presentation, we're really excited about the profile of STAR-0215, the potential of being an effective treatment, but also one that reduces that burden of treatment. You know, 100% of the patients that we surveyed expressed a willingness to take a test.
Speaker 7: of those patients expressed an interest in switching to those treatments. So you know we do believe that the market will continue to grow but also we believe that given the profile of STAR-215 that we'll be able to successfully switch transition patients from either orals or other injectables onto STAR-2.
Speaker 6: Start at 0.215. Great, Andy. And actually, I'm sorry. I apologize. I have one follow-up question and I apologize for this. Maybe just a little bit of a shout out to Noah. We noticed that, you know, your fourth quarter spend was lower than what we expected and we've been kind of, you know, being more cautious in our outlook for spend by small-cap biotechs. Noah, if you can just talk a little bit about how you see the progression of your opex through the rest of the year. And again, thank you.
Speaker 6: I think without getting into too many specifics about quarter over quarter expense, I think, you know, a gradual ramp as we ramp up clinical activities is the right way to think about it.
Speaker 6: I think without getting into too many specifics about quarter over quarter expense, I think, you know, a gradual ramp as we ramp up clinical activities is the right way to think about it. Great. Thank you. Thanks everyone.
Speaker 1: Thanks for the question, Tarsh. Our next question comes from Oliver McCammon from LifeSci Capital. Please go ahead, Oliver. Beware that we have only how many mundane tasks to leave online.
Speaker 3: Hi, this is Oliver McCammon filling in for Sam Slutsky. Just one question from me. For the ongoing phase one study in healthy volunteers, how might the data from the 1200 milligram subcutaneous and 600 milligram IV cohorts impact your strategy on the future clinical development of 215?
Speaker 3: versus what is already known from the prior cohorts. Thanks so much for taking my question.
Speaker 3: Hi Oliver, this is Chris. Thanks for the question and it's an important one. The data that we've obtained so far are compelling and suggests that we have the capability with this molecule to achieve a profile that could target every six months administration people sufficient enough to prevent attacks in a meaningful way.
Speaker 3: We have a half-life dial that's about four months long and we have no evidence so far of safety signals that would give us pause.
Speaker 3: What we are doing with these additional cohorts is asking the question, can higher concentrations maintain S.0215, higher initial concentrations maintain S.0215 over six months above that critical threshold, which we think is 12 micrograms per mil or 18 nanomolar, associated with robust targeting events and strong pharmacodynamic activity.
Speaker 3: We're also asking the question, how well tolerated is administrations of SIR0215 to achieve these kinds of concentrations?
Speaker 3: Based on what we've seen so far, I believe we do not need to go up to 1200 milligrams to achieve a profile that would be, that would allow for six month administration, but this subject in Healthy Volunteers will give us the upper limit that we can stretch to as we think about how to do so.
Speaker 3: what we've seen so far, I believe we do not need to go up to 1200 milligrams to achieve a profile that would be, that would allow for six-month administration, but this subject and healthy volunteers will give us the upper limit that we can stretch to if you think about how to do so. Thank you very much.
Speaker 1: Thanks for the questions, Oliver. Our next question comes from Joe Pangenis from HC Wainry. Please go ahead, Joe.
Speaker 7: Everybody, good morning. Thanks for the questions and thanks for a very efficient call. So just a couple questions on AlphaStar. So first, as the HAE market grows and getting a little more crowded slowly with new therapies and therapies that are growing, you know, how do you view, I mean, it's not a big study, but you know, how do you view additional trials and competition for patients?
Speaker 3: is that there is now wide access to medicines that have the potential to be effective. There's also access to additional trials. How could we design this in a way that would allow patients to feel comfort that they're going to get something out of it? So we eliminated the placebo group, and we've done so using strong science to support the data integrity that we'll get from this.
Speaker 3: And that simple act of eliminating the placebo group has resounded favorably in the community And you know optimistically that will allow for some people who were hesitant to enter a trial In which for up to nine months they would not receive anything but their on-demand therapy are now thinking about this trial
Speaker 3: We've also been working incredibly closely with the HEE physician and patient community. This space is fortunate in that the advocacy organization that is based in the U.S. with outreaches throughout the world through the HEEI is very strong as an active community.
Speaker 3: works well with us as a partner, and is helping us think about how to operationalize a study in a way that makes sense for people living with this disease. We've been working with the physician community to understand how to talk with the community about their potential participation.
Speaker 3: And the final point is that it's a global trial with a big footprint. We have, I think we've now been pretty open about this, we have lots of sites that we're targeting to participate in this trial and we hope that even if sites find just one patient to potentially participate that we'll be able to enroll this in a way that meets our operational guidelines.
Speaker 7: That's very helpful, thanks. And I guess when you look at the data you have and the plan that you have for AlphaStar and the long-term dosing intervals, how do you look to present the data and also the potential impact on any statistics you're looking at with the potential or anticipated, albeit small, anticipated needs for the rescue meds?
Speaker 3: What we anticipate is that we will have proof of concept data in mid-2024 and that will include initial data from all three of these cohorts. Those initial data would be able to communicate what we think would be meaningful for the community. What we would like to be able to show is that
Speaker 3: The profile from a safety perspective is favorable, that there aren't any additional or unexpected safety findings. That we have robust, durable reduction in attacks, in this case, measured from baseline, change from baseline and attack frequency. We have PK and PD that's supportive of the clinical and safety findings that we've been describing.
Speaker 3: and that we have a meaningful and positive impact on quality of life. This is a disease, as you know from other trials, this is a disease that in proof of concept trials, using a small sample size allows for a demonstrably meaningful representation of data.
Speaker 3: Typically in Phase 1B, two trials in the space, cohorts are about four to seven subjects. That's exactly where we anticipate being here with the option to add more if we need to. The reason for that is that we anticipate a very large effect size. Lanadelumab, curadacimab in Phase 3 are showing about 85% reduction.
Speaker 3: compared to placebo, that size in terms of change from baseline allows for a smaller overall sample size. So even with this few number of subjects in each cohort, we anticipate being able to demonstrate that this has the potential for meaningful effects with patients.
Speaker 8: Okay, thank you.
Speaker 1: Thanks for the questions, Joe. Our next question comes from Eun Yang from Jefferies. Please go ahead, Eun.
Speaker 9: This is Yoon. Can you hear me okay? Yes, we can. Thank you. So the proof of concept data that we are expecting next year. So you mentioned the workbook cohort. So how many...
Speaker 9: So, follow-up, are we expecting when we see the data? And then second question is the, you mentioned it's a safety, follow the PKP, the changes in our tag rate.
Speaker 9: Because it's a single dose, we are not going to see, I'm assuming that you are not going to see a text-free rate in this study, correct?
Speaker 3: Thanks for these questions. In terms of data, we are anticipating proof of concept data in mid-2024. The proof of concept data should be able to demonstrate that we are on target to achieve our target profile, which as you know is reducing effects when given every three months or potentially every six months. The proof of concept data should be able to demonstrate that we are on target to achieve our target profile.
Speaker 3: So while I can't guide you today to what we anticipate showing in mid-24, I could tell you that we're looking to be able to show data that would support that kind of profile.
Speaker 3: Regarding your question about endpoints, the proportion of people who are attacked via the meaningful and important endpoint, it is possible that with this profile, given its PK curve and as you know now the PD effects out through at least 84 days, that we can show a substantial number of people that have a significant impact on the endpoints.
Speaker 9: Canada up and running and sounds like a patient having enrolled as we speak and then European sites to open maybe this year. When you involve patients, do you have to enroll in sequential from call to one to three or can you actually
Speaker 9: in more patients simultaneously across facilities and corners.
Speaker 3: Right, so the protocol as written calls for a safety check before we start COVID-2. That's the one requirement that's in the protocol so far. Beyond that, it is possible that we can enroll one and not completely fill it before we start the other.
Speaker 3: At this point, we anticipate not enrolling all three at the same time for a variety of reasons, the most important being just the accumulation of data. So, while the answer to your question is mixed, we don't have to go exactly through each one to start the next, but we are staggering to start a core two.
Speaker 9: Do you have a kind of a ratio in terms of number of patients being enrolled in the US, Canada versus Europe ?
Speaker 10: I don't. Thank you very much.
Speaker 11: Thank you for the questions, Eun.
Speaker 1: So our next question comes from Michael Higgins from Ladenburg. Please go ahead, Michael.
Speaker 12: Morning guys, thanks for taking the questions. Um, question on, um,
Speaker 12: the cohorts in Phase 1a. Are there triggers for adding cohorts in Alpha Star? If you can share this with us, we'd appreciate it. Thanks.
Speaker 12: Michael, could you maybe clarify your question? The phase 1a data to trigger AlphaStar? Yeah, no, in phase 1a there were additional cohorts added obviously from the first three to the next two. I'm wondering if there are any triggers to add additional cohorts in AlphaStar.
Speaker 3: So we have added the possibility to add cohorts to Alpha Star. Actually that's been sort of in our mind from the beginning. We've done that now with adding cohort 3 to test the feasibility of a regimen that could achieve potential for every six months.
Speaker 3: dosing, there aren't any A priority defined triggers for additional cohorts. However, if evolving data from our trial or from the phase one show that there might be additional questions to ask, we do have that possibility. Okay. And then one follow-up. I'll listen to that and then you'll you'll have an opportunity to wrap up. Return to the Sorry.
Speaker 12: Are you doing anything in the current trials or potentially future trials to reduce injection site reactions? Hasn't been a major issue so far but curious your thoughts there. Thanks.
Speaker 3: Yeah, so yeah we're fortunate that the injection type reaction data are very reassuring so far. We've had a few, they've been mild. The most common one is just redness, which is fairly common when you inject anything under your skin. So, so far it is comforting to know that there's nothing here that makes us concerned about moving forward.
Speaker 3: injection site reactions and that's work that's ongoing and we'll certainly be able to fill you and the community in about that as those those efforts continue
Speaker 12: I think you have one more in here. Question on the IV. If you could review for us your rationale for testing an IV, the 600 milligrams and in the phase 1A again. Thanks.
Speaker 3: Sure, so there's two main. One is that 600 milligrams IV will provide a very high concentration and what we're more concerned about in the phase 1A data is the effect of the concentration than anything else and that will allow us the ability to get to a high concentration and watch.
Speaker 3: the P.K. profile, P.D. profile, ultimately safety profile over time, over the full eight months of follow-up. The second is that we have some additional questions regarding bioavailability and absorption that comparing the IV, 600 milligrams IV, to the 600 milligrams of instantaneous dose would help us answer.
Speaker 11: I appreciate that. Thanks guys. Thank you for the questions, Michael. This concludes our question and answer session. I'll now turn the call back over to Jill.
Speaker 2: Thank you, Tara. Thank you all for joining our call this morning and for your continued support of Astria. We'll keep you updated as we execute on our STAR 0215 program, the AlphaSTAR trial, and share other areas of progress at the company. We look forward to speaking with you again.
Speaker 1: Andrew, 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.
Speaker 13: I.