Astria Therapeutics Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 13, 2023

There are 13 speakers on the call.

Operator

Good morning and welcome to the Astra Therapeutics Quarter 3, 2023 Corporate Update. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the q and a text box at the bottom of the webcast player or by emailing your questions to questions atlifesizeadvisors.com. As a reminder, this call is being recorded and a replay will be made available on the Astra website following the conclusion of the event.

Operator

I'd now like to turn the call over to Liz Higgins, Director of Communications and Investor Relations at AstraZen Therapeutics. Please go ahead, Liz.

Speaker 1

Thank you, Tara. Welcome to today's Astra Therapeutics Q3 2023 conference call. With me today are Jill Milne, Chief Executive Officer Christopher Morbido, Chief Medical Officer Andrew Kumiani, Chief Commercial Officer Andrew Matthews, Chief Business Officer and Noah Klazer, Chief Financial Officer. We We issued a press release this morning summarizing our corporate update and Q3 financial results, which we will reference on today's call and is available on our website. We are also using slides during today's call that are available within the Events and Presentations section in the Investors part of our website.

Speaker 1

I would like to note during today's event, as mentioned on slide 2, we will be making forward looking statements related to our business based on current and future expectations. 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 10 ks and are 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 Mill, Chief Executive Officer. Jill?

Speaker 2

Good morning, and thank you for joining our earnings call. 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 ACAI Annual Meeting, we shared Phase 1a data for STAR-two fifteen, our lead program, that supports our vision for STAR-two fifteen to be the 1st choice Preventative treatment for hereditary angioedema or HAE. The data confirm the potential for STAR215 to prevent HAE attacks with dosing 2 or 4 times per year. 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.

Speaker 2

Last month, we also announced the expansion of our pipeline with STAR-three ten. We plan to present a preclinical profile for this program next year with a planned IND submission by the end of 2024 And Phase 1a initiation expected in Q1, 2025. Our focus for Astria is to develop first choice products to 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. 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.

Speaker 2

Very much in line with this strategy is our STAR215 program. We think that STAR215 is very well positioned to be the 1st choice preventative treatment to help utilize the lives of patients Living with HAE, a rare, life changing, and at times life threatening disease. STAR-three ten 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. 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 STAR215'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 burden.

Speaker 2

Our ALPHA STAR trial in HAE patients is progressing very well. We are now planning to share meaningful initial proof of Concept results in Q1 of 2024. Assuming positive results from this trial, we plan to initiate a pivotal Phase 3 trial In Q1 of 2025 and are looking at ways to accelerate this timeline. We are Actively working on the design of our Phase 3 trial. With STAR-three ten, we expect to submit an IND 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.

Speaker 2

Next, assuming positive results in the Phase 1a trial, we anticipate initiating a Phase 1b clinical trial in atopic dermatitis patients In the second half of twenty twenty five, I will now turn it over to Chris Morabito, our Chief Medical Officer, Who will review the new data we have seen for STAR215. Chris?

Speaker 3

Thanks, Jill. STAR 215 is a potential first choice treatment for the prevention of attacks in hereditary angioedema. 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 It could be immensely painful or leave them disfigured for several days or worse, could be fatal. For most patients, it's caused by a deficiency in a protein called C1 inhibitor, which is an important component of the body's complement system.

Speaker 3

Deficiency 1 inhibitor may lead to runaway plasmacallophene activity producing bradykinin that causes the painful swelling attacks I characterized HAE. STAR-two fifteen inhibits plasma caligrene in order to prevent bradychitisin release and subsequent swelling, The same mechanism as market leader, TAKHZYRO. 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 HAE and help to normalize their lives. STAR-two fifteen is a YTE modified extended half life monoclonal antibody, which is a trusted modality in HAE. STAR215 has the potential to support dosing every 3 every 6 months, and we have formulated it to be high concentration and citrate free For self administration, that may be less painful.

Speaker 3

As Jill mentioned, we have now shared the results of our Phase 1 Healthy subject trial 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. The phase 1a trial of 215 is a randomized, double blind, placebo controlled trial conducted in 41 healthy subjects. Shown here are the 5 single dose cohorts.

Speaker 3

The 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 1 through 3 and the initial results for cohorts 45. Ultimately, we are very pleased To see that these results support both every 3 and every 6 month dosing strategies for a potential HAE preventative therapy With robust attack suppression and low treatment burden. On slide 8, we turn to the pharmacokinetic results. In the graph, you can see the rapid and sustained increases in 215. In the 600 milligram dose, for example, Concentrations above 12 micrograms per ml, the threshold we believe is associated with clinical benefit, were achieved at about 11 hours after the dose was administered.

Speaker 3

For all of the doses above 100 milligrams concentrations remained above the threshold for clinical benefit for more than 84 days or 3 months. Based on these data, we estimate the half life of 215 to be up to 127 days. We also saw favorable Safety and tolerability with 215 and no serious adverse events or discontinuations due to an adverse event. The most common treatment emergent adverse events observed were associated with injection site reactions of erythema, pruritus and swelling. Here we see our modeling for potential 3 6 month dosing regimens updated with these newest data.

Speaker 3

As you see, these results confirm our approach to evaluate administration of 215 every 3 and every 6 months. On the left side, we have a simulated 3 month dosing regimen that begins with a 600 milligram loading dose on day 0 And it follows it up with a 300 milligram dose of given then every 3 months. We are pleased to see that this dosing regimen can maintain C trough levels at about 25 micrograms per ml, well above the 12 microgram per ml threshold associated with prevention of HAE attacks. On the graph on the right, we have a simulated 6 month dosing regimen, which begins with a 600 milligram loading dose and then 600 milligrams every 6 months Starting 28 days later. Again, we see sea trough levels that stay well above the 12 microgram per ml threshold, this time at 27 micrograms per ml.

Speaker 3

Based on these results, we believe that both of these regimens could be successful in preventing HAE attacks, And 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 STAR215 data as well as lanedelimab data Acknowledging that these are data from 2 different healthy subjects single dose cooked clinical trials. With 215, we saw statistically significant inhibition of last pcalifene activity observed through day 140 after single doses of 306 100 milligrams And through day 224 after single doses of 1200 milligrams subcu. The percent inhibition of plazmecalacrine is maintained through day 84 after single doses at levels greater than or similar to those achieved by lanadelumab at peak.

Speaker 3

Given the promising healthy subject results, we are excited to be studying STAR-two fifteen in HEE patients. Here is an outline of our AlphaStar trial, which is currently evaluating STAR215 in HAE patients. We are pleased to share that this trial is progressing well, And we are currently enrolling into the 3rd cohort. We are now planning to share initial proof of concept results in HEE patients In the Q1 of 2024, assuming positive results from this trial, we expect to initiate pivotal Phase 3 trial in Q1 2025, We are looking at strategies to accelerate this timeline. The Altusolar long term open label trial is open.

Speaker 3

Now there are data occurring of participants who have received multiple doses of STAR-two fifteen. I will now turn it over to Andrew Cuminotti, Our Chief Commercial Officer, who will review the results of some new market research. Andrew?

Speaker 4

Thank you, Chris, and good morning, everyone. Our vision for STAR-two fifteen is to develop a treatment option that can help normalize the lives of patients with HAE. 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 3 and every 6 month dosing options for STAR 2 15. We presented STAR 0215's profile with both 3 6 month dosing options to 92 HAE patients and caregivers And 60 HAE treatment providers. On the left graph, you can see that 90% of patients Are likely to ask their HCPs about a product with STAR0215's profile with every 3 month dosing And 97% of HCPs are likely to prescribe.

Speaker 4

On the right, you see that 76% of patients are likely to ask their prescribers about the profile with every 6 month dosing and 93% of prescribers are likely to prescriber. While the patients and caregivers indicated a slightly higher preference for a 3 month dosing regimen, Both options indicated a high level of interest from both patients and from prescribers. Given the faster development timeline for a 3 month dosing regimen, we intend to prioritize clinical development for every 3 month administration, Followed by a 6 month dosing option, enabling patients to choose a regimen that works best for them. So in summary, we're excited about the potential of STAR-two fifteen becoming the 1st choice preventative treatment For HAE patients for the following reasons. 1, as Chris shared earlier, we have compelling data From our 180 trial that supports its potential best in class profile.

Speaker 4

2, star0215's mechanism of action And modality are proven safe and effective in HAE as demonstrated by the current market leader. 3, star 2 15 has the potential to provide rapid and durable protection against HAE attacks. For Star 2 15 citric acid free formulation is expected to reduce injection site pain associated with formulations that contain citrate buffers. Finally, we plan to develop star 0 215 in options that support patient choice by prioritizing development on a 3 month dose option first, Followed by a 6 month dosing regimen. We see a very bright future for STAR-two fifteen as the potential first choice Preventative HAE therapy and we look forward to providing you additional updates on our progress next quarter.

Speaker 4

I'll now turn it over to Andrea Matthews, our Chief Business Officer, who will introduce our Star 0 310 program. Andrea?

Speaker 5

Thanks, Andrew. Let's turn to our 2nd program, STAR-three ten, in atopic dermatitis. Atopic dermatitis It 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 5% of the U. S.

Speaker 5

Population. Half of these cases are reported to be moderate to severe. The burden experienced by moderate to severe atopic dermatitis patients can be significant and can include intense itch, inflamed skin, sleep U. S. Sales for targeted therapies for psoriasis were approximately $1,000,000,000 in 2010, and that's when there were 2 Drug classes approved compared to more than 17,000,000,000 in 2022 with 15 approved therapies across 4 major drug classes.

Speaker 5

In atopic dermatitis, there are currently only 2 approved drug classes for biologic therapies. 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 $26,000,000,000 by 2,030. Currently, Dupixent is the market leader for targeted atopic dermatitis treatments. And our base case assumption is that OX40 treatments will be after in the treatment regimen for atopic dermatitis.

Speaker 5

However, there's 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 STAR310. I'll now hand the presentation over to Chris, who will review the disease pathology of atopic

Speaker 3

Thank you, Andrea. Here you can see the immune dysregulation in atopic dermatitis can be complex. Current approved biologics and other late stage Non OX45 logics target only the type 2 pathway hitting downstream cytokines from TH2 cells. But AD is more complicated than this. Type 1 and Type 3 pathways also contribute to this disease.

Speaker 3

STAR-three ten is an OX40 inhibitor which targets multiple effector T cell pathways. It aims to reduce the activity of a broader group of T cells that are known to contribute to the disease and It has the potential to induce higher rates of clinical responses in more patients than currently available biologics and may be disease modifying. Here we do a deeper dive on the OX40 pathway programs. There are 3 programs that have achieved clinical proof of concept: Aveltelemab from Sanofi, which targets ARX40 ligand, roplitinumab from Amgen and telozorlimab, Which is the parent program for STAR-three ten, both of which target OX40 on activated T cells. All three of these programs have seen promising clinical efficacy results through Phase 2b in atopic dermatitis.

Speaker 3

Now the telimab targets X40 ligand, which is expressed in a wider array of Cell types, which could lead to increased risk for respiratory and vascular adverse events. Rapitinumab is an efucosylated anti ox40, which is selective for T cells, but depletes T cells via enhanced ADCC. T cell depletion leads to cytokine cytokine release and Potential increased risk of infection. 310 is the next generation of telesorlimab. 310 is designed to have higher affinity, Greater potency and YTE half life extension technology.

Speaker 3

We believe that 310 has the potential to be 1st choice, OX40 for moderate to severe atopic 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. The half life of 3 10 is extended with And the goal of with the goal of reducing the time between doses. And we also believe that we have The potential to administer 310 with subcutaneous delivery. 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.

Speaker 3

We have filed a provisional patent application for STAR-three ten that if converted, Granted and nationalized would provide patent term extension through 2,044 before taking into consideration any potential patent term As noted, we believe that 310 could be a best in class and first choice of treatment for atopic dermatitis. Starting first with common factors for OX40 pathway monoclonal antibodies, targeting this pathway has the ability to have disease modifying impacts. The OX40 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. We also believe that due to the YTE modification, long acting 310 has the potential to be administered 4 to 6 times per year Compared to the anticipated 12 times per year for amitelumab and ruxolitinumab.

Speaker 3

We believe the safety profile of 310 will differentiate from both On roblotinimab and amatilimab, SV-ten has the potential for reduced T cell depletion due to ADCC And limited potential for AEs due to off target binding. Beyond atopic dermatitis, we believe that target neOX40 has potential in a broad range of additional indications. Noah Clauser, our Chief Financial Officer, will now review our financial information and

Speaker 6

As of September 30, 2023, we had $188,800,000 in cash, cash equivalents and short term investments. In October 2023, we closed a $64,000,000 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 Star 215 and Star 310, Including for STAR-two fifteen, support for all program activities up to the initiation of the planned pivotal Phase 3 trial And for STAR-three ten, the anticipated submission of an IND, the planned Phase 1a clinical trial in healthy subjects, And any related anticipated milestone payments. Also illustrated here is a summary of our outstanding equity.

Speaker 6

In addition to our 36,300,000 outstanding common shares, we now have 1,600,000 prefunded warrants And 5,200,000 as converted preferred shares. So in total, we have 43,100,000 outstanding common equivalent shares. For additional financial information, please see our earnings press release issued earlier this morning and our 10 ks, which we plan to file with the SEC Aftermarket today. I will now touch on upkeep coming milestones and then we will open up for questions. 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 6

Next year is a big year as we expect to report proof of concept results for STAR215 patients in Q1 and for STAR310, we plan to submit an IND by year end. Our ultimate goal is to bring first choice therapies to patients,

Operator

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. So our first question comes from Eun Yang from Jefferies. Please go ahead, Eun.

Operator

Eun, you might be on mute.

Speaker 7

Yes. Can you hear me okay? Yes, we can. Okay. Great.

Speaker 7

Thank you very much. So Can you talk about so Phase 1b data in HAE patients have been accelerated. Can you talk about what Has caused the accelerated time line for the data readout? And second question is on Phase III. I think that Qiu mentioned that it's going to start in Q1 2025, but you are Looking into expedite the timeline.

Speaker 7

So Phase 3, do you think the design would be similar Q, ASO targeting bricalikryme from Ionis or do you think that you may And an active competitor such as TEGSILO for the efficacy comparison. Thank you.

Speaker 2

Great. Thanks, Eun. And Chris will address those questions.

Speaker 3

Yes. Thanks, Eun. Yes, we're very excited about the ability to demonstrate Initial proof of concept data in patients and even more excited that the timeline for that has been accelerated now to Q1. And the reason for that is because we've now achieved target enrollment in cohorts 12 and are enrolling into cohort 3 And anticipate that we will achieve a planned interim analysis trigger earlier than anticipated. So the data that we plan to share in Q1 will be based on the interim analysis that will trigger in Q1 And as mentioned during the call, aim to provide meaningful POC data demonstrated that Whether STAR-two fifteen may be effective when given every 3 months and every 6 months to patients.

Speaker 3

The second question about the Phase 3 design, yes, we are anticipating that the Phase 3 It is in Q1, but we're looking at every opportunity to potentially accelerate that. 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 treatment period and that the primary endpoint would be similar to what's been used also in Phase 3 studies, which is essentially changed from baseline And, or versus placebo and and monthly attack rates.

Speaker 7

Thank you.

Operator

Sure. Thanks for the questions, Eun. Our next question comes from Sam Slutsky at LifeSci Capital. Please go ahead, Sam.

Speaker 8

Hey, good morning, everyone. Thanks for the questions and congrats on the updates. Just 2 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 Page 3, as you think about the different dosing regimens that you might take forward.

Speaker 2

Yes. Chris?

Speaker 3

Yeah, sure. Hi, Sam. So right, we don't have a placebo, but we've built into this 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 PGE, specifically, whether a dose can be prevented for 3 months and a dose can be prevented for 6 months.

Speaker 8

Okay. And then just as you think about the quicker enrollment you saw in Alphastar and read through to Phase 3, Anything that stands out, whether it be certain sites you may reuse or just patient feedback in terms of your derisking regimens, etcetera, as we think about timelines for Phase 3? Sure.

Speaker 3

So I think 2 key things, have contributed to the accelerated timelines here. 1 is the profile. I think that when we talk with physicians, the community, the patients, 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, 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. And the second is the trial design. I think we've had a lot of we put a lot of Effort into thinking about a clinical trial that would provide meaningful data in a timely fashion.

Speaker 3

And you pointed out Which is, the lack of a placebo group, which for many, is a detriment. So eliminating the placebo group and and thinking about dosing regimens that, Again, it appears to be attractive to Sison and also to patients.

Speaker 8

Awesome. Thank you.

Operator

Thanks for the question, Sam. Our next question comes from Seema Chorin from Evercore. Please go ahead, Seema.

Speaker 9

Hi. Thank you for taking my questions. My first question is on the proof of concept data that is coming in first Like, I know this study is small, but, what do you think is a win in terms of reduction in HAE attack rates For this upcoming data readout? And I will follow-up.

Speaker 3

Right. So The traditional way of looking at efficacy here is by looking at essentially the monthly attack rates over time. What has been done in other Phase 1b and 2 trials is looking at this endpoint and there's Between 75 to 100 percent reductions with small sample sizes at various dose levels. 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 3 months, Looking at people who are attack free at 6 months, and that hasn't been previously reported in any significantly meaningful way.

Speaker 3

So that's something that I think what differentiate us in terms of 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 attack free for those predefined periods of time.

Speaker 9

That's helpful. Thank you. And also just curious why there's less interest from dogs and patients for 6 months dosing, than 3 months?

Speaker 4

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. We don't intend that to happen. We understand that the efficacy is an important element of treatment.

Speaker 4

So Our intention is to develop a highly effective treatment for both a 3 6 month dose. So We believe that that might be an issue. The second issue is that the patients that had the 6 month dosing option had obviously 2 injections. And what quite a few patients, especially with TEXYRO experience is injection site pain associated with the citrate buffer. We obviously we're going to be developing a citrate free buffer and we expect to have that level of pain Be significantly reduced.

Speaker 4

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're 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.

Speaker 9

That's very helpful. Thank you. My last question is on the data that was presented at A. Kai. If you can speak about the read through

Speaker 2

Yes. So with regard so yes, so ANRx I 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 8Rx. 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, over the weekend about their program is that, From what we understood, they are currently limited on which dose they can take forward based on safety concerns. And the 2 mg per kg dose that they are advancing first to patients does not appear that it will get them through every 6 month dosing.

Speaker 2

And so obviously, lots more information to come from them.

Speaker 9

That's helpful. Thank you for taking my questions.

Operator

Thanks for the question, Seema. Our next question comes from Hartaj Singh from Oppenheimer. Please go ahead, Hartaj.

Speaker 10

Hey, 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, you know, we saw concordance in our survey, but I had just a couple of questions 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.

Speaker 10

The pair dynamic and the competitiveness is also, I imagine, a thing. So one, what are you hearing from payers? Or if you haven't gone there yet, what's the work you're thinking of doing there, I'm preparing. Secondly, there still seemed to be somewhat of a lack of awareness. There was a core group of our 25 physicians That seem to really know 2 and 5 very well and others that seem to be sort of, you know, kind of aware of it.

Speaker 10

How are you going to tackle that? And then lastly, for Chris, just on biomarkers. Chris, the biomarkers you've been showing us from preclinical and Phase I, could those in any way Help in the Phase 3 trial, in coming with the design that could be faster. Thank you for the questions.

Speaker 4

Sure. So we did a payer landscape assessment earlier this year. And what we learned is that at least right now, Ultimately, patients can get the product that physicians will prescribe In HAE, but over the class is going to continue to be managed. So, No. I think like in other rare diseases, there might be some work associated with getting patients onto the treatment that they want.

Speaker 4

But generally, you can get there. But again, the class will continue to be managed more actively As more treatments become available. The other thing that we heard is, is that efficacy, 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 that Hopefully, it 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.

Speaker 4

So that's what we're learning from the payers in the U. S. 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 creating a medical affairs function. We started that process earlier this year.

Speaker 4

We're looking to grow that. So, you know, I think that our awareness amongst the top one KOLs is very high. I think our awareness within the HAE community continues to grow. But, you know, 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.

Speaker 3

And Hartaj, 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 dataset that we'll bring to regulators But not relying on it. As I mentioned before in other meetings that we've had, I think PK is Meetings that we've had here in investor settings. The PK itself I think is a stronger Supporter of potential effectiveness, we target 12 micrograms per ml as the threshold we believe confers the potential for effectiveness. So we've been looking very closely at that.

Speaker 3

We will be looking obviously at PK in patients in our Phase 3 trial. So PK and PD will support, but I don't think replace the data set we'll be able to use for Phase 3.

Speaker 10

Great. Thank you for all the questions.

Operator

Thanks for the questions, Hartaj. Our next question comes from Joe Pantginis from H. C. Wainwright. Please go ahead, Joe.

Operator

Joe, are you there? Okay. We'll go to the next analyst until Joe is able to connect. So our next question comes from Ingrid Reitjemeyer from Wedbush. Please go ahead, Ingrid.

Operator

Ingrid, you might be on mute. Ingrid, are you on mute? To the audience, please give us a second. So our next question comes from Farhana Sakwa from Ladenburg. Please mute your line unmute your

Speaker 11

line. 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.

Speaker 11

You guys said that the 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, and there is going to be a placebo arm. So do you see that there will be an impact on enrollment?

Speaker 3

I do think that there will be an impact on enrollments, but I think that we'll be mitigated, for a variety with a variety of factors, including, ideally strong, proof of concept data that will Continue to support the profile and raise awareness among sites. 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. And We've been working very closely with the community in, not just, 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.

Speaker 2

Thank you.

Operator

Thanks for the questions, Farhana. Our next question comes from Joe Pantginis from H. C. Wainwright. Please go ahead, Joe.

Speaker 12

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.

Speaker 12

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. You need to be able to get to You know, more solar OLE data, you know, additional follow-up across the board, you know, what kind of logistics, you know, design, regulatory discussions In CMC, I basically listed a lot there.

Speaker 12

But what do you think are the rate limiting steps?

Speaker 3

Well, Joe, you answered the question yourself. I think you've outlined all 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 critical path or rate limiting. Just to repeat what you said, after we get the data, we need to analyze them, understand them, and finalize the approach for phase 3. We need to get regulatory input From not just the U.

Speaker 3

S. But around the world, as I mentioned, we plan to make this a global trial. Obviously, we're making drug 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 So we're going to be looking very deeply at all of those steps. And as mentioned before, look for opportunities to accelerate. And when we share the updates with the Q1 data, we anticipate being able to share a more robust timeline to Phase 3 as well as the Phase 3 trial itself.

Speaker 12

Appreciate the color. Thanks.

Speaker 3

Sure.

Operator

Thanks for the questions, Joe. Our final question comes from Ingrid Reitschhermeier from Wedbush. Please go ahead, Ingrid.

Speaker 7

Hi, this is Ingrid on for Laura Chico. Just any color on the baseline characteristics You can share at this time of the patients you have enrolled in the AlphaStar trial. Just trying to get a sense of, demographics, if you can share that.

Speaker 3

Thank you. Yes. 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 this space. And, in fact, we we designed ours based on, Other trials.

Speaker 3

So we would anticipate a similar set of baseline demographics in terms of the severity of the disease 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.

Speaker 3

So The data will be limited to patients from U. S. And Canada.

Operator

Thank you. Thanks for the questions, Ingrid. This concludes today's Q and A session. I'll now turn the call back over to Jill.

Speaker 2

Thank you, operator. And thank you all for joining our call this morning and for your continued support of Astrea. We'll keep you updated as we on our STAR-two fifteen program, the AlphaStar trial and share other areas of progress at the company, including our STAR-three ten program. We look forward to speaking with you again soon. Liz?

Speaker 1

That concludes today's call. A webcast replay will be available for 90 days

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Key Takeaways

  • Compelling Phase 1a data for STAR-215 demonstrate extended half-life (up to 127 days) and robust attack-suppression PK/PD supporting both 3- and 6-month dosing with no serious adverse events.
  • The AlphaStar Phase 1b trial in hereditary angioedema patients is enrolling rapidly, with initial proof-of-concept results expected in Q1 2024 and a pivotal Phase 3 trial planned for Q1 2025.
  • Astra expanded its pipeline with STAR-310, an anti-OX40 antibody for moderate to severe atopic dermatitis, targeting an IND submission by year-end 2024 and Phase 1a initiation in Q1 2025 with potential best-in-class safety and dosing advantages.
  • Market research shows high interest in STAR-215’s extended-interval regimens, with 90% of patients and 97% of physicians likely to choose a 3-month option (76%/93% for 6-month), prompting prioritization of the 3-month dosing strategy.
  • Astra ended Q3 2023 with $188.8 million in cash, cash equivalents, and short-term investments and closed a $64 million October financing, providing runway into 2026 to fund key milestones for both programs.
AI Generated. May Contain Errors.
Earnings Conference Call
Astria Therapeutics Q3 2023
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