Q2 2021 Aldeyra Therapeutics Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the and Dara Therapeutics second quarter 2021 financial results conference call. At this time, all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session I would now like to hand, the conference over to the company's Chief Financial Officer Joshua Reed. Please go ahead Sir.
Good morning, everyone with me is Dr. Todd Brady, President and Chief Executive Officer of Aldara.
This morning, we issued a press release reporting our financial results for the quarter ended June 32021.
A copy of the press release is available on the investors and media section of our website www dot out there of Dot com.
Please note that this morning's conference call contains forward looking statements regarding future events and the future performance of out there.
Forward looking statements include statements regarding submission of potential new drug application potential commercialization and.
<unk> timing of results from our clinical trials, our projected cash runway.
Our possible or assumed future results of operations expenses and financial position and potential growth opportunities among other things.
These statements are based upon the information available to the company today.
These statements reflect out there is current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including the development clinical and regulatory plans or expectations for our <unk> product candidate and systems based approaches the risks that results from clinical trials or portions of Clinton.
Trial may not accurately predict the results or future trials for the same or different indications and out there is continuing review and quality control analysis of clinical data.
As a result of the COVID-19, pandemic clinical site availability and staffing and patient recruitment have been negatively affected and the timeline to complete our clinical trials may be delayed.
There seems no obligation to update these statements as circumstances change.
Future events and actual results could differ materially from those projected and the company's forward looking statements, including the current and potential future impact of the COVID-19 pandemic on our business results of operations and financial position.
Additional information concerning factors that could cause results to differ materially from our forward looking statements are described in greater detail and the Companys press release issued this morning, and our filings with the SEC.
I will now turn the call over to Dr. Brady.
Okay.
Thank you Joshua and good morning.
We begin this morning with the exciting news relating to our retinal disease program over the past few weeks. The FDA has granted orphan drug designation to ATX 21, 91, the lead product candidate and our retinal disease pipeline for the treatment of 2 additional.
Rare disorders Pri.
Primary vitreoretinal lymphoma, and retinitis pigmentosa.
Primary Vitreoretinal lymphoma is a rare aggressive high grade cancer that affects approximately 2800 people and the United States with approximately 600, new cases diagnosed annually.
Retinitis Pigmentosa is the clinical group of rare genetic eye diseases that affects an estimated 82000 to 110000 individuals and the United States and approximately 1 in 4000 people.
Worldwide.
As noted in this morning's news release, we plan to initiate a phase 2 clinical trial of AVX 21, 91 in patients with retinitis Pigmentosa and this year.
AVX 21, 91 has now received orphan drug designation for 3 distinct clinical indications that affect the retina and <unk>.
Primary vitreoretinal lymphoma retinitis pigmentosa.
And proliferative vitriol retinopathy, a sight threatening condition and the leading cause of failure of retinal detachment surgery and for which we have received fast track designation from the FDA.
The provision the prevention and proliferative retinopathy as many of you know is the focus of our ongoing phase III Guard trial heart, 1 of which is scheduled to conclude enrollment at the end of this year.
Together these designations highlight the broad platform potential of AVX 21, 91 to treat a spectrum of rare yet serious retinal disorders, none of which have approved therapies.
Particularly as a result of the recent orphan designations and primary Vitreoretinal lymphoma, and retinitis Pigmentosa, we will be updating you on future calls as to regulatory timelines and the development process for <unk> 'twenty 191 across the retinal disease platform.
Yes.
Turning to our anterior segment ophthalmology pipeline, we remain on track to discuss results of our phase III invigorate trial, and our regulatory strategy for approximate app and ocular allergy with the FDA this year.
The discussion and follows the successful completion of invigorate and April were approximately <unk> demonstrated highly statistically significant improvement over vehicle for the primary endpoint of ocular itching.
And the key secondary endpoint of ocular redness as well as all secondary endpoints.
Okay.
Patient enrollment continues and our phase 3 tranquility trial and for proxy lab for dry eye disease with enrollment and the identical tranquility to trial on track to begin this quarter.
Ocular redness as the primary endpoint of these 2 day trials with rasp level Schirmer test and dry eye symptoms.
And as secondary endpoints.
We expect to enroll approximately 150 patients per arm and each trial and.
And topline results are planned for the fourth quarter of this year.
In parallel with tranquility.
We have initiated a multicenter double masked randomized vehicle controlled parallel group phase 2 clinical trial and dry eye disease.
Purpose of this trial is to optimize the tier collection process.
And measure rasp.
Similar to tranquility the primary endpoint of the trial is ocular redness.
In addition to our ocular programs, we remain excited about the extension of the therapeutic potential of rasp inhibition to systemic inflammatory disease.
Initial results from phase III trials, and asthma psoriasis and COVID-19 of AVX 6 to 9 our first in class orally available and irreversible covalent inhibitor of pro inflammatory rasp are anticipated in the fourth quarter of 2021 or the first quarter.
2022.
In addition to the disease areas currently under study.
We are evaluating the possibility of expanding clinical testing of <unk> 6 to 9 and other systemic indications, where rasp may mediate path ology, and where current therapy is either inadequately effective or toxic.
We look forward to updating you on our progress along these lines later this year.
With that I'll turn the call back over to Joshua to review, our second quarter financial results.
Thank you Todd cash and cash equivalents as of June 32021 were $249.7 million.
Based on our current operating plan, we believe that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submissions former proximal lap initial commercialization of our profitable App if approved and continued development of our <unk>.
Product candidates and ocular and systemic immune mediated diseases.
Turning now to our second quarter 2021 results research and development expenses were $11.5 million for the quarter ended June 32021, compared with $4.9 million for the same period and 2020 the.
The increase of $6.6 million is primarily related to the increase and clinical research and development expenditures.
General and administrative expenses were $3.1 million for the quarter ended June 32021, compared with $2.2 million for the quarter ended June 32020.
The increase of $900000 and is primarily due to an increase and personnel related costs and other miscellaneous administrative expenses.
The net loss for the second quarter of 2021 was $14.9 million or 28 per share compared with a net loss of $7.5 million or 25 per share for the quarter ended June 32020.
Looking at our Investor calendar, Todd and I will be participating and a number of investor conferences in the coming months, including events hosted by Jefferies Citi BTG, HC Wainwright and Bahrenburg.
Please check the events and presentation section of our website for details and now I'll hand, the call back over to Todd for closing comments.
Thank you Joshua.
<unk> continues to make significant progress.
Toward our goal of developing effective and highly differentiated new therapies to treat immune mediated diseases with significant unmet medical need.
We are excited about the first line and potential for approximate <unk> as a treatment for anterior surface inflammatory diseases that for a significant percentage of patients are not being adequately controlled by standard of care approaches.
Beyond the anterior segment, we are developing innovative medicines for retinal inflammatory diseases that we believe will create near term high value commercial opportunities for our pipeline.
And finally, we're committed to expanding our therapeutic applications to systemic inflammatory diseases, representing a myriad of conditions that are today not sufficiently treated.
With that Joshua and I will be happy to take your questions operator.
Thank you and as a reminder to ask a question you will need to press star 1 on your telephone and withdraw your question press the pound key.
Please standby, while we compile the Q&A roster.
Your first question comes from the line of Marc Goodman with SVP Leerink.
Yes, good morning.
Can you talk about this new indication for <unk>. So.
First of all.
Your other.
Ideas there came from the docs at mass eye and ear and you bought the technology out this 1 come from them too or.
I'm just kind of curious where the idea came from why starting the study now.
Has.
The methotrexate off label.
And used for this indication before maybe you could just give us a little history of that and then.
This is their screening and.
And it takes place and systems and genetic disease, and just curious about that and.
And then also on the phase III to optimize the rep. The last level study that you talked about there is that an FDA requirement is this going to be 1 of those supplements. After you file.
Just curious.
Clark Thank you.
Mark Good morning, and.
Thanks as always for the excellent question and the focus on retinitis Pigmentosa a program about which we're very excited and you can tell from our prepared comments.
Morning <unk>.
Genesis of retinitis Pigmentosa as it relates to methotrexate.
He is a.
Yes.
Paper that was published out of case Western and the University of Pittsburgh, That's highlighted and our corporate deck that was updated and posted this morning and you can see the data.
And the deck, which suggest that methotrexate is particularly important and.
And <unk> and MS folding rhodopsin is a protein that's critical and the.
And the light sensation Cascade, and then and the retina.
And methotrexate seems to be able to.
And prevent rhodopsin, Miss holding and certain Gina types of retinitis Pigmentosa. So the answer to the second part of your question is that patients and the upcoming clinical trial will be screened genetically and <unk>.
Not only to identify retinitis pigmentosa, but this particular subtype. This genetic subtype of retinitis pigmentosa that seems to respond well.
And to methotrexate.
Regarding your question.
About the phase 2 trial and dry disease that we mentioned this morning, and our prepared comments. This is not aid and FDA requirement, but as you know, we're particularly interested in assessing rasp levels and tears rasp is the target of our drug if we can successfully.
Demonstrate changes and rasp following drug administration, and then I believe we will be the first company ever to demonstrate that a topical drug.
Can affect the target of that drug and the tiers of patients.
We're also interested potentially and highlighting the changes and RASK and the pharmacology section.
Our potential drug label.
And if if commercialized so we're taking the assessment of RASK and very seriously and hence at this phase III trial, which as we mentioned is designed to optimize tier collection, obviously, a pivotal process and the assessment of rasp.
Thanks.
Thanks Mark.
And your next question comes from the line of Eagle, Nicole Mohit <unk> with Citigroup.
Hi, Greg Hi, Todd and Josh. Thank you very much for taking the question I just wanted to follow up on the on that phase II trial that Youre running book It would be 1 that you just announced.
Saying the purpose is to optimize the tier collection process and measure rasp could you just help us understand a little bit better why this wasn't possible within the context of the 2 tranquility phase III.
Of course, and good morning, all and thanks for the question and I'm happy to clarify the phase 2 trial.
The tranquility trials are identical and based on the highly successful run and cohort from January.
And as part of Tranquility, we've identified ocular redness as the primary endpoint ocular redness has numerous advantages.
Not to mention the fact that we've consistently demonstrated activity and ocular redness with for proxy lab, not only and dry eye disease, but also ocular allergy, but also because ocular redness as probably the sign the exclusive triad is E sign.
That matters to patients patients do not care about schirmer test patients do not care about ocular staining or any other so called signs of dry disease and hence our selection.
Ocular <unk>.
Redness, Nonetheless, as I mentioned.
And response to marks and good question prior we're still very interested and assessing rasp and.
And presenting RASK data.
To the street, and potentially including Ras data and our product label. This is why we've initiated this study tier collection is tricky.
As you know and dry eye patients.
Tears are at a premium there just aren't very many tears and many and many subjects. The result of that is difficult to measure RAF we require about 3 micro liters of tears.
To generate a rasp signal from a single subject and believe it or not about 25 per cent of the subjects and the running cohort for tranquility and we're not able to produce.
3 micro liters or more tiers and this is why we are altering optimizing the tier collection process and that ultimately is what this trial is about as I mentioned, though equal ocular redness remains the primary end point here and this phase III.
Trial.
Got it. Thank you so a few housekeeping questions on on your plans and process for disclosing tranquility.
Firstly, we'll that will both trials be reported at the same time.
Second will you be conducting any type of a pooled analysis of these 2 trials and then finally.
What should we expect with respect to the top line release beyond ocular redness are we also going to see the Trs level data the schirmer test data and the dry eye symptoms and the topline release. Thank you.
Yes, I do think that.
We will disclose the tranquility trials serially.
They are run and a staggered fashion.
I do not expect that we will announce the results of both trials together just given timing issues.
We're big fans of pooling as you know.
And pooling as part of the NDA submission process I do expect you'll see pooled data at some point, though it may not be.
At the data releases.
For for obvious.
Reason.
Ocular redness is the primary endpoint, we are also interested and schirmer test.
And tier rasp levels as we have discussed schirmer test and Trs levels will be secondary endpoints and.
Represent to other.
FDA designated that signs of dry eye disease. We're also assessing dry eye disease symptoms. So in terms of secondary endpoints youll see a couple of different signs as well as dry eye disease symptoms within the.
Within the chamber.
Great. Thank you very much thanks Nicole.
And your next question comes from the line of Edwin Zhang with H C. Wainwright.
Hi, simple cookie and my question.
You recognize it pigmentosa have you done any.
Ian false works before you decide to go after that.
And that take disease.
Do you need to do any preclinical or clinical test before you start the phase 2 trial.
My second question quick 1 for allergic conjunctivitis have builder and it feedbacks.
From the FDA.
What's the revenue.
The regulatory pathway going forward.
Thank you.
Thanks, Edwin and further questions.
And the retinitis Pigmentosa paper that cited and our corporate deck is a remarkable scientific work the investigators screened tens of thousands of compounds against certain genetic.
Subtypes of retinitis Pigmentosa.
And methotrexate surface to the top.
Of those in terms of preventing reduction and this folding.
The investigators have it presented a variety of preclinical data including.
Animal injections.
<unk> injections and multiple injections and I think as a body of work.
And the paper and the results are remarkably compelling which is why we've.
And why we intend to initiate a clinical trial and retinitis Pigmentosa. Nonetheless to your question. We have now confirmed the activity of methotrexate in vitro and <unk>.
Human cell lines that have been genetically modified and 2 different laboratories.
So yes, we have confirmed the work we typically will attempt to replicate.
The scientific literature before we initiate a clinical trial I can tell you and that the investigators for the upcoming trial are ecstatic about the potential of a new therapy and retinitis Pigmentosa as I mentioned, there is no approved therapy and the disease is difficult to treat and in many cases.
Leads to blindness, so I think from the patient perspective for the investigator perspective, and certainly from our perspective, we're all very excited about getting this trial going and translating this exciting preclinical work and to a clinical trial.
In terms of allergic conjunctivitis, we are still in dialogue with the FDA.
We mentioned, we expect those discussions to occur this year and of course, we'll be updating the street accordingly, once we have that.
Clarity on that.
And that series of discussions.
Paul I think we're ready for the next quarter.
And your next question comes from the line of Tom Shrader with BT and EE.
And.
Hey, good morning, Thanks for taking the questions.
Couple of questions on 6 to 9 as we get close to data from <unk>.
For the psoriasis readout do you expect there is enough data there to make a reasonable comparison with psoriasis as standard of care and.
And for atopic asthma, who are the patients here are these patients well controlled on current medications.
Quite impaired patients just a sense of how noisy that datasets going to be thank you.
Great questions.
Thank you.
The intent of the 3 phase III trials that we're running for 6 to 9.6 to 9.
Just to clarify how the drug is working particularly in terms of cytokine and RASK profiles and.
Which cytokines are elevated which cytokines are depressed, which rasp are controlled how quickly do those biomarker.
Signals a change there.
There probably will be some clinical data of relevance that can be derived from these studies, but obviously theyre not powered.
To detect.
Statistical changes and clinical end points and really the clinical changes arent the point.
Of the trials.
I think with ATX 6 to 9 we've taken a very deliberate systematic approach to identifying.
The kinds of diseases that might respond.
2 the drug which is why we chose psoriasis and asthma.
Which sit at 2 different ends of the inflammatory cascade psoriasis sort of th 1 autoimmune disease.
Atopic asthma, obviously and allergic th 2 hypersensitivity.
<unk> disease, and we're all very eager to see how the drug behaves, particularly from a biomarker standpoint, and these 2 different flavors of inflammation Covid is a mix of all of the above as you know.
Some of these patients have cytokine response syndrome cytokine storm.
And there were interested and seeing how the drug works broadly I'll note that and our corporate deck, we have cytokine data from from.
From <unk>.
And some time ago I believe we presented those data at Quad AI and some years ago and and what you can see is the activity of our proxy lab, which is closely related to AVX 69, structurally is remarkable and all of the inflammatory cytokines ph 1 ph 2 that we tested seemed to be.
Following therapy, whereas IL 10, which is the key anti inflammatory cytokines, but was up regulated and Thats why we say that rasp are pre cytokine systems based mediators of inflammation and if you can inhibit rasp with your proxy lap or <unk> 69 or other.
Rules and our platform.
The idea is to flip a switch from pro inflammatory.
And 2 and anti inflammatory.
And again this is why we've selected a spectrum of diseases. Many people don't know this but 1 reason, we tested <unk> and dry eye disease and allergic conjunctivitis is it those 2 diseases also sit at sort of opposite ends of the inflammatory cascade of th 1.
Type disease, and autoimmune type disease, and dry eye and a th 2 are hypersensitivity type disease, and allergic conjunctivitis, well Lo and behold, we have activity and both of those conditions. So I think it's possible that with regard to <unk> 609, we will see activity.
Across the board at least in terms of a biomarker standpoint to the point to the.
To the question about clinical readout and of course, we will attempt to measure positive scores and pulmonary function tests and the normal things that any sponsor would attempt to assess and these indications, but don't expect to have a large dataset along those lines at least clinically.
In terms of the patient population in asthma and <unk>.
Topic asthma is interesting. These are patients that are triggered by allergan.
Hence the hypersensitivity th 2 nature of the patient population.
And in that way, we required patients to have and allergic response in terms of pulmonary function testing and so forth.
To certain allergens and we will challenge those patients. This is a crossover trial. So each patient will be exposed to drug and placebo at different times and the response to that.
Challenge will be key in terms of our biomarker and clinical assessments.
Thank you that was perfect.
Thanks, Tom.
Cash.
And as a reminder to ask a question you will need to press Star then the number 1 on your telephone keypad.
Your next question comes from the line of current car.
And all with Jones trading.
Hi, good morning, Thanks for taking my questions for <unk> 291.
And our rate and that is pigmentosa, what endpoint could you study and phase 2 and any clarity on what our regulatory pathway could look like.
And.
And secondly, any clarity on the planned NDA submission for <unk>.
You can have 2 lenders updates from the diamond David that would be super helpful. Thank you.
For sure for car and.
And thanks for the question.
It is early to comment on the regulatory pathway for retinitis Pigmentosa.
And tell you.
And that other sponsors have explored.
Clinical challenges as primary endpoints for later stage trials, such as walking through amaze and the dark and there are a variety of creative Clint.
Clinical outcomes that can be tested and later stage trials.
The point of the current trial that we disclosed this morning is not that the point is to assess the activity of AVX 21, 91 in terms of.
Biomarker assessments and.
And OTT other types of.
Radiographic and morphological assessments that are typically used to to gauge the activity of the drug and retinitis Pigmentosa 1 positive aspect about testing rare retinal diseases at the retina can be observed directly.
And and thanks for taking my question Justice you'd think about a potential filing timeline do you <unk> do you anticipate the safety experience I've tranquillity wanted to to be sufficient based on current enrollment progress.
Hi, good morning, Isabel and thanks for the question.
The gating factor for the NDA filing for Approx slab as I have mentioned on prior calls is not tranquility.
It is the safety that trial.
As you point out.
The FDA for most NDA submissions requires a detailed and dedicated safety trial usually.
Longer.
And then the typical efficacy trial, and our case or chronic efficacy trials or 12 weeks long.
And for symptom assessment.
And the case of the safety study that trial is 12 months long.
And so the idea is to estimate and da filing based on the last patient.
Last visit and that safety trial, we do believe that will be able to file.
Or submit the NDA based on 6 months of patient safety data.
We continue to reader reiterate prior guidance that the NDA for Approx Alap will go in late this year or early next year.
But the exact timing as I mentioned depends on.
C.
Nature of enrollment and the timing of enrollment and.
And the and the safety trial.
Regarding your point about the safety database, which is different from the safety trial.
We think we're well within the normal safety database and bounds for numbers of patients just based on the number of phase 2 and phase III trials that we have performed.
And and dry disease. So we don't anticipate any issues in terms of the size of the patient safety database.
Great. Thanks.
Thanks and developed.
And your next question comes from the line of Kelly She with Jeffrey.
Hi, This is how an accounting for candy shifts. So my question is about the face to Repko Colleen try ipv's slip out.
Design is it going to be the same asset to contradict 2 trials, we so focused on optimizing the tier grasp collection and then my second and questioning about the.
The commercialization of retro in price and and AC.
What's your thoughts right now.
Potential may be launched yourself or collaborations.
Good morning, Hong excellent question about the phase 2 RAF trial and dry.
I really did not highlight that trial design and my prepared comments the answer to your question is yes.
The trial design is substantially similar to tranquillity, 1 and tranquillity too and that the phase 2 is a 2 day trial day..1 is the 4 doses of drug day.
Day, 2 is a dose of drug prior to a 90 minute dry eye disease chamber and and the middle of that chamber at approximately minute 45, there's a second dose of drug.
What has changed in terms of the protocol for the phase 2 rats trial.
Is that we're collecting tears, particularly on day, 1 with a different.
The schedule of events.
Lots of ways to connect to collect tears that most the 2 most common ways are the use of a capillary which is a small glass tube that's inserted.
Into the into the I, just above the lower lid and over a period of 5 to 10 minutes tears.
By capillary action are sequestered and the 2 the other way is to use a shermer test strip as you know shermer tests are small strips of paper.
That are placed and.
And the cold, the sock and and the tier Lake and tears.
Are absorbed into that strip the strips and then b.
Frozen and subsequently spun down.
And analyzed.
That way the timing of capillary extraction versus the timing of schirmer.
Strip extraction and the order of those procedures is what's being optimized and.
And the phase 2 trial, particularly for the assessment of Wrath I don't expect that those protocol changes will have any effect.
On the chamber data on day, 2 particularly in terms of the symptom assessment and the chamber and the redness assessment and the chamber, but really the.
Phase 2 is is focused on day, 1 and a tear collection there to optimize the RAF signal.
More so than we might see and the tranquility trials and back to me goals earlier question about what will we see in terms of secondary and points and the run and trial.
We did announce his shermer test.
We announced the symptoms, so we announced ocular redness.
All relatively quickly after the completion of the trial Rasp assessment takes a longer period of time.
And and the run and trial, we announced the rash data after.
The top line data from the other and points was released the reason for that is that the tears need to be shipped to a third party laboratory.
Where a qualified and validated process is used to analyze the rasp levels and tears all of that takes more time and is more complicated and standard dry eye disease sign assessments and this case, we're not yet clear.
And as to when the rasp data will be.
Released relative to the other data from these.
Phase 2 and phase 3 trials will be updating investors as we get closer to those.
And data Readouts.
Maybe for the commercialization and approaches for Approx slap all I'll turn that answer over to Joshua who can comment further.
Sure. Thanks for the question.
From a commercialization standpoint, we are committed to following.
The path that is and the best long term interest of out there.
And our shareholders on.
On the business development from our discussions are robust.
The early onset of activity and broad symptom improvement profile over a proxy lab continue.
To generate significant interest from potential strategic partners, so that address and sort of the beady side of the equation.
With respect to go with them going it alone we have approximately $250 million in cash.
Which is sufficient to.
Begin initial commercialization efforts for Approx a lab. So we have a number of different options that we're exploring here and we believe that we're well positioned to capitalize on the opportunity.
Thank you and congrats on getting the addition, often destination for 2 on that 1 yeah.
Yes, Thanks Hon. We're thrilled.
And your next question comes from the line of Esther Hong with bearing Burke.
Hi, good morning, and thanks for taking my questions.
And 80 X 21, 90 line can you give us an update on the ongoing <unk> study.
And P. B R. And then also with multiple ongoing programs, which could possibly advanced quite cash and then I've just got a quick and follow up thanks.
Thanks faster and good to hear your voice I'm glad you asked about 80.821 91 and this is a program that I think has been largely ignored.
By and investors, Yes, as I said and my prepared comments 21, 91 represents a near term high value commercial opportunity.
And and not only and 1 clinical indication, but and 3 clinical indications.
The PBR program is going well.
We have as of this morning reiterated our guidance that will complete enrollment and the guard phase III program.
This year all.
Point out that 1 thing we've observed with the guard trial is that many.
And all surgeons are already treating PBR with methotrexate.
Off label, if you will that is it seems like the de facto standard of care treatment of Pbr's already methotrexate.
And we're really thrilled to be able to present to the retinal community.
Controlled data along these lines eagerly anticipating the results of the guard trial, because I do think that.
The results have the potential to validate.
What is sort of done and a standard of care on a standard of care basis today in terms of treatment of the disease and we look forward to and.
Announcing goes results sometime.
Next year.
There are multiple programs as you point out with 21, 91, and I really do believe that.
21, 91 represents a platform approach as you know methotrexate has been used and many many different indications. It is a known and potent anti inflammatory and anti fibrotic drug with.
Hundreds of thousands of patients worth of clinical experience well as you know it turns out that methotrexate is injected into the I'd per my prior comments and <unk>.
Regarding proliferate vitriol retinopathy and now ocular lymphoma.
In terms of which.
Indication will make it to the market first we don't yet know.
We are optimistic about all of them I would say that.
That night as Pigmentosa is the newest of the indications that we're testing.
Would probably place that in terms of timing behind PBR and ocular lymphoma, but we're excited to update the street.
On timelines and regulatory process and so forth if not later this year.
Earlier next year and as I mentioned.
And the beginning of my response to your question. We're just so thrilled about 21.91 and the the potential for our company and for patients and physicians all of these indications that we're pursuing have no approved therapies.
Super Helpful. And then just safety data to date and 21.91. Thanks.
1 advantage of 21.91 is that we do have lots of patient exposure a day.
Data.
With ocular injection some of that data is and our corporate deck with regard to the Massa and your study.
On PBR.
And the scientific literature.
The safety of.
And track killer injection of methotrexate is and.
As well described and well known which represents a real advantage to this compound relative to to Newark compounds.
Expect that with regard to any of the indications that we've described that safety.
Will be an issue simply because the doses that we're using the injection schedule that we're using all have been well described and R and common use and practice for the treatment of these rare diseases.
Great. Thanks, Todd.
Thanks after.
Polly next because your next bill.
And your next question comes from the line of Matt calm and what's the Lions global.
Hey, guys. Good morning, Thanks true for squeezing me and here just have 2 quick ones 1 on the face too.
And your question trial that.
Quite a bit about.
I guess I might've missed this earlier and the call projects.
Apologize to busy morning, but was curious if.
When the study completes how that may impact and if there was some kind of discussion of helps me impacts of labeling but.
Are there any takeaways.
Right.
Evaluate from from this phase 2 that could impact anything youre doing and tranquility is just gonna be for post marketing studies.
Or could there be some.
And I know there as you mentioned, including 1 and 2 will complete serially with a little depth and between them. So wasn't sure this could.
Probably an argument timing, but impact things you may do entry included too.
And then the second question I had was just around enrollment for both so the tranquility studies.
True Colby too and that'll be starting up shortly but was wondering given that you're still committing to having both of those data sets and Q4, whether you've been pre identifying patients for for tranquillity to as you were and raw fish and some true quality 1 even if it hasn't.
And the first opened up yet thanks.
Thanks, Matt for the question I I know you're busy.
There are lots of earnings this time of year and we appreciate you taking the time to join our call.
Excellent questions regarding the face.
2 and the implications of the phase 2.
Not only tranquillity, but to a regulatory package the intensive the phase 2 rats trial and dry disease.
Really is to augment the pharmacology section of the label and.
I would not classify and anyway.
The phase 2 as mission critical.
The NDA submission.
Or the NDA approval process.
But as I mentioned and my prior answers.
The idea of getting Ras data and the pharmacology of this section pharmacology section of the product label is commercially differentiating.
There is no other topical eyedrop that we're aware of that has.
Been able to prove.
Target engagement and.
And the fact that we know how.
How <unk> works and the potential to demonstrate or prove that mechanism of action and the tears of the triad patients.
Think is quite remarkable and should.
Distinguish for Approx lab Mechanistically from the other approaches out there in the triad disease.
Market.
The primary endpoint of the phase II, Nonetheless is ocular redness and.
We have been that consistent and our ability to demonstrate improvement and redness and allergy and dry diseases. I've mentioned previously we remain optimistic about the commercial implications of ocular redness.
Patients generally care about how they look.
They are less interested in.
They are stating scores or their shermer tests, and so forth and so we're really thrilled to have.
Have demonstrated the ocular read this activity that we've shown so far and other trials and that made perfect sense to include ocular read this as the primary endpoint and the phase 2 to the point of your question. Obviously it is a good sign if ocular redness and.
Is dim and improve and an ocular redness has demonstrated in the face to all.
Point out, though that the size of the phase 2 is approximately half the size of the tranquility trials and phase 2 we're expecting about 75 patients per hour 150 patients total which is half that of the.
Tranquillity trials and.
Sauce.
Repowering is.
Is not as robust and the phase 2 as it would be and the phase 3 but.
But then again.
We're not really running the phase 2 for redness, we're running it for Ross.
In terms of trade.
Tranquility, 1 and 2.
The trials as I mentioned are being performed serially.
The same patient population is being enrolled and both trials the enrollment criteria are identical.
And what we've decided is to is to focus on enrollment and tranquillity..1 1 string quality..1 completes full then switch to tranquillity to the beauty of the tranquillity trials is that there are 2 day trials.
Which is awfully convenient for subjects and theory of subject could screen on 1 weekend.
Qualify and then the next weekend finished the trial.
The day, 1 and day 2 can be performed rapidly I think thats and attractive advantage.
Relative to longer trials, but particularly for subjects I would say that enrollment so far and try and quality 1.
And the phase 2 trial has been robust a don't expect at this point any issues with.
Tranquillity too we have seen to date little impact of Covid.
On our enrollment and the tranquility trials and as I mentioned, the 2 day and nature of these trials may have something.
To do with that in terms of being attractive.
The subjects.
Yeah.
Perfect Nope, that's Super Super helpful extra detail Todd I appreciate it and hoped hoping to see that respite and and the label and and can approve of what you are already showing I think between.
A correlation between rasp and and redness so much.
And what's appreciate it thanks perfect. Thanks, Matt.
And at this time there are no further audio questions will now turn the conference back to Doctor Brady for clothing racks.
Well. Thank you for joining us this morning, and as always we look forward to keeping you updated on our progress.
And thank you. This concludes today's conference call. Thank you for your participation you may now disconnect.
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