Astria Therapeutics, Inc. (ATXS) Earnings Call Transcript & Summary

Good morning, and welcome to the Astria Therapeutics Quarter 3 2023 corporate update. [Operator Instructions] As a reminder, this call is being recorded and a replay will be made available on the Astria website following the conclusion of the event. I'd now like to turn the call over to Liz Higgins, Director of Communications and Investor Relations at Astria Therapeutics. Please go ahead, Liz.

Thank you, Tara. Welcome to today's Astria Therapeutics Q3 2023 Conference Call. With me today are Jill Milne, Chief Executive Officer; Christopher Morabito, Chief Medical Officer; Andrew Komjathy, Chief Commercial Officer; Andrea Matthews, Chief Business Officer; and Noah Clauser, Chief Financial Officer. We issued a press release this morning summarizing our corporate update and third quarter financial results, which we'll 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. 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-K and our subsequent SEC filings. Such statements may represent our judgment as of today, and we undertake no obligation to publicly update any forward-looking statements, except as required by law. I will now pass the call over to Jill Milne, Chief Executive Officer. Jill?

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 ACAAI Annual Meeting, we shared positive Phase Ia data for STAR-0215, our lead program, that supports our vision for STAR215 (sic) [ STAR-0215 ] to be the first choice preventative treatment for hereditary angioedema or HAE. The data confirmed the potential for STAR-0215 to prevent HAE attacks with dosing 2 or 4x 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. Last month, we also announced the expansion of our pipeline with STAR-310 (sic) [ STAR-0310 ]. We plan to present a preclinical profile for this program next year, with a planned IND submission by the end of 2024 and Phase Ia initiation expected in Q1 2025. Our focus for Astria is to develop first choice products that improve the health outcomes of patients with allergic and immunological diseases. First choice to us means patients and treating physicians would choose our products because of their strong competitive efficacy, low treatment burden and favorable safety and tolerability profile. 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. Very much in line with this strategy is our STAR-0215 program. We think that STAR-0215 is very well positioned to be the first choice preventative treatment to help utilize the lives of patients living with HAE. A rare, life-changing and at times, life-threatening disease. STAR-0310 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 Ia results at ACAAI this weekend, which further supports STAR-0215'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. 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 III trial in Q1 of 2025 and are looking at ways to accelerate this time line. We are actively working on the design of our Phase III trial. With STAR-0310, 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 Ia trial in Q3 of 2025, which we believe will be an important milestone for the program. Next, assuming positive results in the Phase Ia trial, we anticipate initiating a Phase Ib clinical trial in atopic dermatitis patients in the second half of 2025. I will now turn it over to Chris Morabito, our Chief Medical Officer, who will review the new data we have seen for STAR-0215. Chris?

Thanks, Jill. STAR-0215 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 that could be immensely painful or leave them disfigured for several days or worse could be fatal. For most patients, is caused by a deficiency in a protein called C1 inhibitor, which is an important component of the body's complement system. Deficiency 1 inhibitor may lead to runaway plastic kallikrein activity producing bradykinin that causes the painful swelling attacks that characterize HAE. STAR-0215 inhibits plasma kallikrein in order to prevent bradykinin release and subsequent swelling. The same mechanism as market leader, TAKHZYRO. We believe that 215 has the potential to differentiate from currently available therapies and our goal is to reduce the disease and treatment burden for people living with HAE and help to normalize their lives. STAR-0215 is a YTE modified, extended half-life monoclonal antibody which is a trusted modality in HAE. STAR-0215 has the potential to support dosing every 3 and every 6 months, and we have formulated it to be high concentration and citrate-free for self-administration that may be less painful. As Jill mentioned, we have now shared the results of our Phase I healthy subject trial up through day 224 days and these data support our vision for the program. I will now review them in more detail in the coming slides. The Phase Ia trial of 215 is a randomized, double-blind, placebo-controlled trial conducted in 41 healthy subjects shown here on the 5 single-dose cohorts. The results I will share over the next few slides include safety, tolerability, PK and PD data through the full follow-up period for cohorts 1 through 3 and the initial results for Cohorts 4 and 5. 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 and 600-milligram dose, for example, concentration is about 12 micrograms per ml, the threshold that we believe is associated with clinical benefit were achieved at about 11 hours after the dose was administered. 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 immersion adverse events observed were associated with injection site reactions of erythema, pruritus and swelling. Here, we see our modeling for a potential 3- and 6-month dosing regimen updated with these newest data. As you see, these results confirm our approach to evaluate administration of 215 over 3 and every 6 months. On the left side, we have a simulated 3-month dosing regimens that begins with the 600-milligram loading dose on day 0 and then follows it up with a 300-milligram dose 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 the 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 C trough levels that stay well above the 12-microgram per ml threshold this time by 27 micrograms per ml. 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 reported substrate assay in healthy subjects and includes STAR-0215 data as well as lanadelumab data, acknowledging that these are data from 2 different healthy subject single-dose clinical trials. With 215, we saw statistically significant inhibition of plasma kallikrein activity observed through day 140 after single doses of 300 and 600 milligrams and through day 224 after single doses of 1,200 milligrams subcu. The percent inhibition of plasma kallikrein is maintained through D84 after single doses at levels square than or similar to those achieved by lanadelumab at peak. Given the promising healthy subject results, we are excited to be studying STAR-0215 in ATE patients. Here's an outline of our ALPHA-STAR trial, which is currently evaluating STAR-0215 in HAE patients. We are pleased to share that this trial is progressing well, and we are currently enrolling into the third cohort. We are now planning to share initial proof-of-concept results in HAE patients in the first quarter of 2024. Assuming positive results from this trial, we expect to initiate a pivotal Phase III trial in Q1 2025 and we are looking at strategies to accelerate this time line. The ALPHA-SOLAR long-term Open-Label trial is open. Now there are data accruing and participants who have received multiple doses of STAR-0215. I will now turn it over to Andrew Komjathy, our Chief Commercial Officer, who will review the results of some new market research. Andrew?

Thank you, Chris, and good morning, everyone. Our vision for STAR-0215 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-0215. We presented STAR-0215's profile with both 3- and 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 our product with STAR-0215's profile with every 3-month dosing and 97% of HCPs are likely to prescribe. On the right, you see that 76% of patients are likely to ask the prescribers about the profile with every 6-month dosing and 93% of prescribers are likely to prescribe. 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 time line 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-0215 becoming a first choice preventative treatment for HAE patients for the following reasons: One, as Chris shared earlier, we have compelling data from our Ia trial that supports its potential best-in-class profile. Two, STAR-0215's mechanism of action and modality are proven safe and effective in HAE as demonstrated by the current market leader. Three, STAR-0215 has the potential to provide rapid and durable protection against HAE attacks. Four, STAR-0215's citric acid free formulation is expected to reduce an injection site vein associated with formulations that contain citrate buffer. Finally, we plan to develop STAR-0215 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-0215 as the potential first choice preventative HAE therapy, and we look forward to providing you additional updates on our progress next quarter. I'll now turn it over to Andrea Matthews, our Chief Business Officer, who will introduce our STAR-0310 program. Andrea?

Thanks, Andrew. Let's turn to our second program, STAR-0310 and atopic dermatitis. Atopic dermatitis is an immune disorder associated with loss of skin barrier function and itching. It is driven by diverse mechanisms, which span the spectrum of T cell-driven pathology, and it affects approximately 5% of the U.S. 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 disruption and depression and infection. Here, you see psoriasis demonstrates precedence for growth for market growth and evolution for targeted therapies in dermatology. U.S. sales for targeted therapies for psoriasis were approximately $1 billion in 2010, and that's when there were 2 drug classes approved compared to more than $17 million in 2022 with 15 approved therapies across 4 major drug classes. In atopic dermatitis, there are currently only 2 approved drug classes for biologic therapies. Given the higher prevalence of atopic dermatitis, psoriasis, we and others see that the atopic dermatitis market has even greater potential. We think that the moderate to severe atopic dermatitis treatment market could reach $26 billion by 2030. Currently, DUPIXENT is the market leader for targeted atopic dermatitis treatments and our base case assumption is that OX40 treatments will be after DUPIXENT in the treatment regimen for atopic dermatitis. However, there's good rationale for this to evolve prior to the potential launch of our program. In both scenarios, we believe that there is substantial opportunity for STAR-0310. I'll now hand the presentation over to Chris, who will review the disease pathology of atopic dermatitis and also our mission for STAR-0310. Chris?

Thank you, Andrea. Here, you can see the immune dysregulation in atopic dermatitis can be complex. Current approved biologics and other late-stage non-OX40 biologics 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. STAR-0310 is an OX40 inhibitor, which targets multiple effector T cell pathways. It aims to reduce the activity of a broader group of TH cells that are known to contribute to the disease and has the potential to induce higher rates of clinical responses in more patients than currently available biologic and may be disease modifier. Here we do a deeper dive on the OX40 pathway programs. There are 3 programs that have achieved clinical proof-of-concept. Amlitelimab from Sanofi, which targets OX40 Ligand. Rocatinlimab from Amgen and Telazorlimab, which is the parent program for STAR-0310, both of which target OX40 on activated T cells. All 3 of these programs have seen promising clinical efficacy results through Phase IIb in atopic dermatitis. Amlitelimab targets OX40 Ligand, which is expressed in a wider array of cell types, which could lead to increased risk for respiratory and vascular adverse events. Rocatinlimab is an epacosilated anti-OX40, which is selective for T cells, but depletes T cells via enhanced ADCC. T cell depletion leads to cytokine release and potential increased risk of infection. 310 is the next generation of Telazorlimab. 310 is designed to have higher affinity greater potency and YTE half-life extension technology. We believe that 310 has the potential to be the first 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 we can match or beat the efficacy seen in other OX40 programs. The half-life of 310 is extended with YTE technology. 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. We have filed a provisional patent application for STAR-0310 that if converted granted and nationalized would provide patent term extension through 2044 before taking into consideration any potential patent term extensions. As noted, we believe that 310 could be a best-in-class and first choice 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 -- 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 amlitelimab and rocatinlimab we believe the safety profile of 310 will differentiate from both rocatinlimab and amlitelimab as 310 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 targeting the OX40 has strong potential in a broad range of additional indications. Noah Clauser, our Chief Financial Officer, will now review our financial information and upcoming milestones. Noah?

Thank you, Chris. On this slide, I'll provide a brief summary of important financial information. As of September 30, 2023, we had $188.8 million in cash, cash equivalents and short-term investments. In October 2023, we closed a $64 million underwritten offering. Following the October financing, we expect our cash to support our current operating plan into 2026. Our current operating plan includes the development of STAR-0215 and STAR-0310, including for STAR-0215, support for all program activities up to the initiation of the planned pivotal Phase III trial and for STAR-0310, the anticipated submission of an IND, the planned Phase Ia clinical trial in healthy subjects and any related anticipated milestone payments. Also illustrated here is a summary of our outstanding equity. In addition to our 36.3 million outstanding common shares, we now have 1.6 million prefunded warrants and 5.2 million as converted preferred shares. So in total, we have 43.1 million outstanding common equivalent shares. For additional financial information, please see our earnings press release issued earlier this morning and our 10-K, which we plan to file with the SEC after market today. I will now touch on upcoming 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 1 clinical milestone each year in the coming years. Next year is a big year, as we expect to report proof-of-concept results for STAR-0215 in patients in Q1 and for STAR-0310 and we plan to submit an IND by year-end. Our ultimate goal is to bring first choice therapies to patients, and we are looking forward to executing on that goal in the years to come. I will now ask the operator to open up the line for questions. Thank you.

[Operator Instructions] So our first question comes from Eun Yang from Jefferies.

Okay. Great. So can you talk about -- so the Phase Ib data in HAE patients have been accelerated. Can you talk about what has caused to accelerate the time line for the data readout and second question is on Phase III. I think you mentioned that it's going to start in first quarter 2025, but you are looking in to expedite the timeline. So Phase III, do you think a design would be similar to ASO targeting [indiscernible] from Ionis? Or do you think that you may add an active competitor such as textile for the efficacy comparison?

Great, Eun and Chris will address those questions.

Yes. Thanks, Eun. Yes, we're very excited about the ability to demonstrate some initial proof-of-concept data in patients and even more excited that the time line for that has been accelerated now to Q1. And the reason for that is because we've now achieved target enrollment in cohorts 1 and 2 and are rolling into Cohort 3 and anticipate that we will achieve in 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 demonstrating that whether STAR-0215 may be effective when given every 3 months and every 6 months to patients. The second question about the Phase III design, yes, we are anticipating that the Phase III 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 III study. Our current assumption is that it will be a placebo-controlled trial that we will not be versus an active comparator. We also assumed that we would have a similar treatment period as other Phase III trials, which specifically is about 6 months treatment period and that the primary endpoint would be similar to what's been used also in Phase III studies, which is essentially change from baseline in -- or versus placebo and monthly attack rates.

Our next question comes from Sam Slutsky of LifeSci Capital.

Congrats on updates. Just 2 for me. I guess for the upcoming ALPHA-STAR interim analysis, given that there's no placebo arm, just what data are you looking for that you would consider when before moving to Phase III as you think about the different dosing regimens that you might take forward?

Yes, Chris?

Yes, sure, Sam. So right, we don't have a placebo, but we've built into this a robust running period in which we collect important baseline information on all of our participants. The planned efficacy analysis has changed from baseline on various efficacy parameters to inform the effectiveness of this drug in HAE, specifically whether a dose can prevent for 3 months and the dose could prevent for 6 months.

Okay. And then just as you think about the quicker enrollment you saw in ALPHA-STAR and read through to Phase III, anything that stands out, whether it be certain sites you may reuse or just patient feedback in terms of your dosing regimens, et cetera, as we think about time lines for Phase III?

Sure. So I think 2 key things have contributed to the accelerated time lines here. One is the profile. And I think that when we talk with physicians, the community, the patients, working with our advocacy organizations. We get a lot of, frankly, positive feedback that the profile is something that is meaningful to patients with this disease, specifically the ability to administer 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 found a lot of -- we've put a lot of effort into thinking about a clinical trial that would provide a meaningful data in a timely fashion. And you pointed out line in question 1, which is the lack of a placebo group, which for many is a detriment. So eliminating the placebo group and thinking about dosing regimens that could provide important data with limited resource utilization, i.e., sample size, again, appears to be attractive to sites and also to patients.

Our next question comes from Sema Sharan from Evercore.

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

Right. So the traditional way of looking at efficacy here is by looking at essentially the monthly attack rates over time. And what has been done in another Phase Ib and II trials, is looking at this endpoint, and there's been between 75% to 100% 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 a proportion of people who were 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. So that's something that I think would differentiate us in terms of this drug's ability to impact meaningfully the lack 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.

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

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 efficacy is an important element of treatment. So our intention is to develop a highly effective treatment for both a 3- and a 6-month dose. So we believe 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 TAKHZYRO 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. So the numbers are relatively small in terms of the difference. I think the good news for us is that both physicians and patients are very excited about both dosing 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.

That's very helpful. My last question is on the [ ADRX ] data that was presented at ACAAI. If you can speak about the read-through from the data for your program?

Yes. So with regard to -- yes, so [ ADRX ] had presented this weekend at ACAAI as well as we have, I think, based on the data that we saw presented by [ ADRX ] we do believe that we have a better chance of technical and regulatory success with STAR-0215 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. And so obviously, lots more information to come from them.

Our next question comes from Hartaj Singh from Oppenheimer.

Great. Thank you for a couple of questions. And then really nice presentation. We had done a survey with 25 high prescribing physicians and a lot of Andrew, what you've been saying was kind of we saw a 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 the payer 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 preparing? Secondly, there still seems to be somewhat of a lack of awareness. There was a core group of our 25 physicians that seem to really know 215 very well and others that seem to be sort of kind of aware of it. 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 in Phase I, could those in any way help in the Phase III trial in coming with the design that could be faster?

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 I think like in other rare diseases, there might be some work associated with getting patients on to the treatment that they want. 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 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 can provide comparable efficacy in terms of attack rate reduction. There's an opportunity for us to keep even more patients attack-free, but then also combine that with a product that patients obviously would be more compliant with. So that's what we're learning from the payers in the U.S. 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. We're looking to grow that. So I think that our awareness amongst top 1 KOLs is very high. I think our awareness within the HAE community continues to grow, but I do believe that we'll continue to publish hopefully very impressive encouraging data that both physicians and patients will be interested in. And as we continue to grow our organization, hopefully, we can increase that share of voice within the community.

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 [ services ] -- so I think we'll be able to use PD to inform the potential data set that will bring to regulators but not rely on it. As I mentioned before in other meetings that we had, I think PK is -- meetings that we've had here in investor settings. So the PK itself, I think, is a stronger supporter of potential effectiveness. We target 12 micrograms per ml as a threshold, we believe confers the potential for effectiveness so we've been looking very closely at that. We will be looking, obviously, at PK in patients in our Phase III trial. So PK and PD will support, but I don't think replace the data set we'll be able to use for fixed rate.

Great.

Our next question comes from Joe Pantginis from H.C. Wainwright. Please go ahead, Joe. Joe are you here? Okay. We'll go to the next analyst until Joe is able to connect. So our next question comes from Ingrid Riemer from Wedbush. Ingrid, you might be on mute. Ingrid, are you on mute? So our next question comes from Farhana Sakloth from Ladenburg.

This is Farhana on behalf of Michael. First, congrats on the quarter. I guess most of our questions have been asked, but I will just follow up on one. You guys said that the Phase II -- I mean, sorry, the Phase Ib was enrolling faster because there was no placebo arm. For the Phase III, if I heard correctly, for the design, there is going to be a placebo arm. So do you see that there will be an impact on enrollment?

I do think that there will be an impact on enrollment, but I think that we'll be able to mitigate it for -- with a variety of factors, including ideally strong proof-of-concept data that will continuing to support the profile and raise awareness and on 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 that 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 then I think we 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 III and enrollment into the trial in Phase III.

Our next question comes from Joe Pantginis from H.C. Wainwright.

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 III. I guess I'll ask it this way. Your goal is to accelerate the timing that you talked about what do you consider the rate-limiting steps? I mean there's a lot going on over the next several months. Do you need to be able to get to more solar OLE data, additional follow-up across the board, what kind of logistics, design, regulatory discussions in CMC, I basically listed a lot there, but what do you think are the rate-limiting steps?

Well Joe, you answer the question yourself. I think you've outlined all of the things that we have to think about as we think about the plan for the start of the Phase III 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 III, we need to get regulatory input from not just the U.S. but around the world, as I mentioned, we plan to make this a global trial. Obviously, we're making drug thinking that we're going to continue dosing people with this disease. So hopefully CMC, doesn't impact highlights too much. But we will have to do some work on dose selection, which can impact the timing for the start of the Phase III. So we're going to be looking very deeply at all of those steps. And as mentioned before, we look for opportunities to accelerate and when we share the update with the Q1 data, we anticipate being able to share a more robust time line to Phase III as well as the Phase III trial itself.

Our final question comes from [ Ingrid Weitemeyer ] from Wedbush.

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 ALPHA-STAR trial? Just trying to get a sense of demographics, if you can share that?

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 the space. And in fact, we designed ours based on other trials. 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 clinical trials that go, we've been up in the U.S. and Canada. So the data will be limited to patients from U.S. and Canada.

Thanks for the questions in Ingrid. This concludes today's Q&A session. I'll now turn the call back over to Jill.

Thank you, operator. Thank you all for joining our call this morning and for your continued support of Astria. We will keep you updated as we execute on our STAR-0215 program, the ALPHA-STAR trial and share other areas of progress at the company, including our STAR-0310 program. We look forward to speaking with you again soon. Liz?

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.