Ventyx Biosciences Inc. Q1 2023 Earnings Call
Speaker 1: Good afternoon ladies and gentlemen and welcome to the show.
Speaker 2: If at any point your question has been answered, you may remove yourself from the queue by pressing star 2. So others can hear your questions clearly, we ask that you pick up your handset for best sound quality. Lastly, if you should require operator assistance, please press star 0. As a reminder, this conference call is being recorded.
Speaker 2: I would now like to turn the call over to Dr. Marty Oster, Vintexas Chief Financial Officer. Please go ahead.
Speaker 3: our first quarter 2023 financial results and providing a business update. As a reminder, the company's most recent investor presentation can be found on our website at www.vintagespio.com and the investors tab in the news and events section. Before we begin the call today, I'd like to remind everyone this conference call and webcast will contain forward-looking statements about the company. You could...
Speaker 3: operations with current cash, cash equivalents, and marketable securities. These statements are subject to risks and uncertainties that could cause actual results to differ. Factors that could cause actual results are outcomes to different materially, from those expressed in or implied by such forth with these statements are discussed in greater detail and are most periodic reports filed at the SEC, including our forum 10Q for the first quarter, which is
Speaker 3: events except it was required by law. With that said, I'll hand the call over now to Dr. V. G. Mohan, Venticsist, Fundered CEO . Rejuvenate, please go ahead.
Speaker 4: Yeah, thanks Marty. So good afternoon to all again and thank you for joining Comentex's first quarter 2023 financial results conference call.
Speaker 4: Let me briefly run through this afternoon's agenda. And given that we just had our call in late March, I'll be brief and keep my comments focused on high-level business update. Bill Sanborn, our President and Chief Medical Officer, will then provide updates across our pipeline programs in a bit more detail. Finally, Marty will present an overview of our first quarter 2020 financial results.
Speaker 4: before we open the call for Q&A.
Speaker 4: As I always like to remind our audience, the foundation of ventix is our mission to bring differentiated, safe and effective oral medicines to large immunology markets and markets with high unmet medical need and that are currently dominated by injectable biologics.
Speaker 4: With 2023 shaping up to be a transformational year for VENTICS, we are off to a great start.
Speaker 4: Our team is executing across the board with five and repeat five phase two clinical trials.
Speaker 4: Now ongoing across our holding-owned pipeline have internally discovered small molecule drug candidates.
Speaker 4: So, with BTX 958.
Speaker 4: We remain confident that we are developing a potential best-in-class allosteric tick-to-inhibitor. Based on class leading target coverage and safety that we observed in Phase 1,
Speaker 4: We see great potential to not only establish a differentiated profile in psoriasis and psoractic arthritis, but also to be a first mover among tick-to inhibitors in Crohn's disease, where we believe our ability to achieve trough.
Speaker 4: IL-23 IC-90 coverage will be particularly important. We have three Phase II trials now underway in Black Surprises, Suriatic Arthritis and Crohn's Disease, and Bill will discuss these in more detail during his section in his comments.
Speaker 4: On the development of an extended release tablet for QD dosing for 958, we continue to make progress towards the target profile, the TPP, and we remain confident that we will have optimized once-daily tablet to advance into Phase 3 trials in 2024.
Speaker 4: for this path, incorporates an iterative process that allows us to sequentially evaluate multiple prototype formulations in humans.
Speaker 4: We look forward to providing a more detailed update in the early part of early second half of 2023.
Speaker 4: With our S1P1 modulator, VTX002.
Speaker 4: We believe we will be the first to truly explore the full potential of this mechanism in an ulcerative colitis, and our aspiration for this asset has always been very clear.
Speaker 4: which are to demonstrate efficacy in moderate to severe UC patients, ulcerative colitis patients, that is unambiguously differentiated from both atrasumard and zephosea, and is competitive with or superior to levels achieved by viologics.
Speaker 4: This efficacy profile, if achieved, should position VTX-002 as a potential class-leading, safe oral agent in ulcerative colitis. And again, bill will provide more color on the progress of this trial.
Speaker 4: Beyond these lead programs, we continue to advance our novel NLRP-3 inhibitor portfolio, including our peripheral NLRP-3 inhibitor VTX2735, which is now in phase 2 trials in CAHPS patients, and a CNS penetrant NLRP-3 inhibitor VTX3232, which is expected to advance into phase 1 studies this quarter.
Speaker 4: So with that, I'll hand it all over to Bill Sandborn for a more detailed pipeline update. Bill, thank you, Raju, and good afternoon, everyone. I'm excited to provide a brief pipeline update today and to highlight recent achievements across our portfolio. I'll begin with BTX 958. As you are all aware, we are now well underway with three phase two trials of BTX 958, including the serenity.
Speaker 4: approximate trough icing 90 coverage of an early con-12 and early con-23.
Speaker 4: So we are really pushing towards viologic-like suppression of interleukin 23 pathway, and we expect this to translate into differentiated efficacy closer to that observed with the anti-IAL 23 antibodies. This is our expectation not only in plaque psoriasis and psoriatic arthritis, but it's
Speaker 4: but also in Crohn's disease where we continue to see a tremendous unmet need for a safe and effective oral therapy and where we believe our class-leading therapeutic window may afford us a strong position relative to competitors.
Looking more closely at the psoriasis market, we remain very excited about the commercial opportunity for orally delivered small molecules to gain both market share versus legacy biologic therapies, as well as to continue to drive expansion of the treated population within two to three million adults, and stop at nearly 98 million doses.
in enrolling the serenity plaque psoriasis trial. As we've stated previously, we are on track to report top-line data in the fourth quarter. We are looking forward to carrying this operational momentum into the other VTX-9x-8 phase two trials, including the Tranquility trial and psoriatic arthritis and the Harmony trial and Crenz disease. And we continue to expect top-line results from both of these trials in 2024. Shifting to VTX-002.
Our S1P1 receptor modulator in phase two development for ulcerative colitis, I think Raju put it well when he said that the goal here is to be the first to truly explore the full potential of this mechanism in ulcerative colitis. This is similar to the story with BTX958.
where we talk about achieving differentiated coverage of the target pathway. You will recall that we previously shared data from our Phase 2 open label extension trial demonstrating that our high dose of 60 milligrams is achieving steady state absolute lymph site concentration or count reductions in the range of 70 plus percent.
compared to approximately 50% per a trasmod in symposia. And we believe that this differentiated parmicodynamic effect will translate into improved efficacy in all sorts of colitis.
And if we take a step back and look at the landscape and ulcerative colitis, this is a large market currently dominated by biologics, which achieved placebo-adjusted clinical remission rates of around just 10% or slightly higher.
And the anti-TNF alphas, the alpha-4 beta-7 integrand inhibitors, and so on, I'll share this characteristic.
There is a significant opportunity for a safe and oral therapy that can exceed this efficacy benchmark. Based on our conversations with physicians, we fully expect the S1P class will grow robustly as supposedly it continues to build volume. Meanwhile, the potential approval of a trasmod is expected later this year.
If we can achieve our target product profile with BTX002, which is placebo-adjusted clinical remission of around 20% or better.
Then we believe there is an opportunity for VTX002 to become a class leading drug and ulcerative colitis. And as we mentioned in the press release, enrollment in the Phase II trial of VTX002 has continued to progress very well.
So we're excited about this program and based on a 13 week primary end point, we are in track to report top line data in the second half of 2023.
Finally, I'll briefly touch on our portfolio of novel oral NLRP3 inhibitors. On our last earnings call, we announced that we have initiated a Phase II proof concept study of our peripheral in our NLRP3 inhibitor, VTX2735, and FIM, Miele-O-Cold Auto-Inflammatory Syndrome, or FCA-
both of these NLRP3 inhibitors has faced two ready clinical candidates by establishing a differentiated profile.
In terms of safety, pharmacokinated and pharmacodynamic activity.
We believe that there is a wide range of high-value indications for future development of both our peripheral NLRP3 inhibitor VTX2735 and our CNS penitrant molecule VTX3232. On the peripheral side mechanism, such indications include cardiovascular, dermatologic, and rheumatologic diseases.
With regard to NLRT3 inhibition in the CNS, there is a strong biologic rationale to potentially address devastating neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease among others.
In summary, this is a very exciting period for Ventex and our portfolio of novel small molecules. Execution has been strong across the pipeline and we are very much looking forward to announcing top-line data for VTX 958 and VTX 002 in the second half of this year.
Before we move on to Q&A, I'd like to hand the call back to Marty for a brief discussion of our financial results. Marty? Thank you, Bill. You'll find details from our financial results for the first quarter ended March 31st in our press release and I believe the 10Q filing is also hit on the website.
And I'll summarize those results here. R&D expenses were $35.4 million for the first quarter of 2023 compared to $17.4 million in the first quarter of 2022. This increase reflects the advancement of our pipeline in the later stages of clinical testing, including execution of the ongoing Phase II trial of VTX002 and ulcerative colitis in the Phase II programs for VTX002.
activities in preparation for the potential launch of phase 3 trials on 01-02 and 958 in 2024.
G&A expenses in the quarter were 7.1 million versus 5.3 million in the first quarter of 2022, and the net loss in the first quarter of 2023 was 38.9 million compared to 22.7 million for the first quarter of 2022. Cash, cash equivalents and marketable securities totaled 376.9 million as of March 31st. This reflects an increase in the number of cash equivalents in the quarter of 2022. G&A expenses in the quarter were 7.8 million for the first quarter of 2022. Cash equivalents and marketable securities totaled 6.9 million for the first quarter of 2022. Cash equivalents and marketable securities totaled 6.9 million for the first quarter of 2022.
With that, we conclude our prepared remarks for this afternoon's call. I'll turn the mic back over to Angela to begin the Q&A session, where I'll be joined by Riju and Bill, operator. The floor is now open for questions. At this time, if you have a question or comment, please press star one on your telephone keypad. If at any point your question is answered, you may remove yourself from the queue by pressing star two. Again, we ask that you pick up your handset when posing your questions to provide optimal sound quality. Thank you.
Our first question is coming from Michael Yee with Jeffree. Please go ahead.
Hey guys thanks for the question, thanks for the updates. We had two areas we wanted to ask on. The first was actually on the S1P one. I know you have data coming up later this year. There have been some studies that have read out recently you know had no placebo and of course some studies like the TL1A had a very low...
versus some of the other recent UC studies that I've read out in the past couple of months. And then the second question is you also have an update on the ER tablet 958. Can you just remind us, are you testing multiple different technologies in that or is that one technology at different doses? Thank you
Excellent. Thanks, Mike. Good to hear from you. Let me have Bill talk about the S1P1 trials and placebo and then I'll come back with the ER tablet.
Yeah, so it's a good question, Mike. You know, I think that trials without placebo arms that are not controlled or not easy to interpret. And so, you know, you just have to take this data with the grain of salt. placebo rates can vary. The average placebo rate in moderate severe ulcerative colitis trials is about seven and a half or eight percent.
of the patients that are coming into the trial, and we do that robustly. You can also sort of monitor the outcomes and pooled-blinded data to see, you know, if the magnitude of response that you're seeing is, you know, just barely crossing the threshold to be a response, or, you know, whether it's a deep and a robust response. I'm not going to get into the details around any of those things except to say we're well aware of all the characteristics and we've monitored the trial very carefully as it has progressed. Good, anything else on that, Mike?
Very helpful, very helpful. And then on the ER tablet, shed some light on that, what's going on with different technologies. Yeah, so on ER tablet, yeah, so it's a good question, and thanks for asking. I can clarify that.
So we have a couple of different technologies, but it seems important to understand that these are sort of complementary technologies. So what we do is we use one technology to make sure we're sort of using birelevent dissolution methods, which is what's happening in the dissolution absorption phase in humans.
And then we complement this with the technology that actually simulates what's actually going to happen, the dynamics, the motility of what actually happens in absorption. So you really are sort of using multiple technologies to make sure...
for lack of a better word, checking the appropriate boxes for both technologies. So if you maximize your chance of then when you go into human data, you've now made sure that you've simulated what you see both in terms of dissolution fluids and...
and the solution rate and also absorption distribution in terms of what actually happens in a system where you've got biosolves and motility, all of those factors and that's sort of that.
a path we take with each iteration that we're doing towards our target product profile for the ER tablet for QD dosing in phase three.
each iteration that we're doing towards our target product profile for the ER tablet for QD dosing in phase 3. Thank you.
You're welcome. Thank you. This comes from Yasmin, where you meet with Vibra Sandler.
Good afternoon team and thank you so much for all the great updates. Two questions for you. Maybe the first one is to start off on S1 P1. I know most of the analysts and investors are very familiar on what the bar is in regards to.
efficacy into that data readout in the second half. But maybe what would be helpful is, Dr. Sanborn, if you could educate us on what do we wanna see from a safety perspective out of this phase IIB that could highlight differentiation. So that's question number one. And then question number two is, you know, tomorrow morning we're gonna...
able to predict sort of
Yes, let me address the protagonist question. Yes, and again, good to hear from you. So yes, the Phase 1 data is supposed to come out tomorrow at the ISID meeting, followed by the more detailed efficacy data that's going to come out sometime in, I believe, the July timeframe. Again, I think we had a similar question at the last call, and I think we have to wait for the data. I think the PK, PD itself might be illustrative to some extent, but the real meat is going to be in the Phase 2 data and how it compares to what we've seen with the phase 1 data.
drugs in this class, the biologics, and the aurels that have come out recently. So it's really difficult to speculate on something we have no idea about. And you and I have talked about the press release that came out early on. So I think let's wait for this data. Let's look at the EKPD. It'll give us a little more color on this class of compounds that we haven't.
regulatory approval in the United States since 2010 when Jelenia was approved for multiple sclerosis. And there's about a million patient years of exposure with Jelenia and their marketed dose has lymphocyte reductions in the low 70s, which is exactly where we are targeting for the higher of our two doses.
the context of the data that we release in the second half of the year from a safety perspective will be in the context of a very well understood class of drugs with respect to all the potential safety issues. So the second thing is to say is that you know we'll be releasing 13 weeks of...
of safety data and so, you know, that's a limited period of time. So, you know, it's not typical that you see a lot of important, what I would say are big ticket adverse events anyway in an early trial, but, you know.
the data will be what they are. As you look specifically what you like to see for drugs that are effective, typically the and well tolerated, you typically will see
completion rates for 12 or 13 weeks in the single digits. So having patients complete the induction course of therapy is one measure of safety and tolerability. Then of course you're looking at the proportions of patients that have severe adverse events and have...
you can see heart rate reductions and AV blocks and those can be substantially mitigated with dosing titration regimens and we think we have a good dosing titration regimen. So seeing what the rates of bradycardia.
is in the first 13 weeks by treatment group and seeing if there are any cases of AV block and those sort of things, those will be of interest and would allow comparing and contrasting with other products which may or may not be titrated. The other things that you see with S1P drugs are generally...
you know, rare and you're not likely to see in a Phase 2 induction study.
Thank you so much for that, our December , where you're coming. The next question comes from Derek Archillo. With Wells Fargo, please go ahead.
Hey guys, thanks for taking the questions just a couple for us. Maybe just first we wanted to get your take on why we won't see a plateau for the TIC-2 class even at IC-90 coverage. I guess some folks point to this Pfizer molecule which allegedly had IC-90 coverage for 24 hours and their 12 week data looking fairly similar to the Kravun.
and Decay to the drug at PAUSE 75 and PAUSE 90. So just love to get your thoughts there. And then also, can you just remind us how many sites you have in the S1P trial and the geographic distribution of those sites and any color on the split you would expect for advanced therapies versus 90s would also be helpful. Thanks.
Yeah, Derek, good question. And, you know, we've seen some of that analysis out there. So, you know, we'll address it again, and I'll have Bill again talk a little bit about this because we have taken it there. But let me just start out on some of the analysis being done out there in terms of coverage.
of the analysis that's been done for Cetic 2N for the two takeda doses that have been done. And look, cross trial comparison with small number of folks is really challenging, but you know, the data are what they are, right? I think our belief is that.
Within those those three Examples again will lead Pfizer out of there so the so tic to 12 milligram dose that people are using to model out the IC 50 coverage for about 18 hours, I think
And the TAC 279, which is the IC 70 for 24 hours. And this is data that they put out there. I think it's pretty consistent with what you can read from the various NEMBUS disclosures.
30 milligrams is IC80. Now our, what we've said is we are going into our phase two trial in particular for psoriasis with...
Cough coverage of IC90 at our top doses.
and then significant coverage for across other doses to be having the trial. But we are going in with dose and doses that cover IC 94, 24 hours, right? And our data are going to read out in the fourth quarter. And we'll see, in our aspiration, as we've said this before, to see differentiated efficacy across.
multiple readouts, so I see 50, 75, and I see 90, and differentiate the efficacy from other compounds that we are now talking about. So that really is the crux of the argument, but going in with maximal coverage, and we hope to show differentiated efficacy from what you've seen here, right? So again, it's...
Yes, I've seen the analysis of these senior analysis and this sort of always leads to this plight-diving effect. In particular, when people are sort of myopically focused on PASSY 75, but let me have Bill, and see if he wants to add a little more to this discussion that you've had before as well. Yeah, I would just say that.
if when the dosing is sufficient to approximate a biologic-like effect with interleukin antibody therapy at the optimal dose, what you see is a consistency across the outcome measures of eh-
trends for PASI 75, 90, and 100. And in phase two trials, you can have outliers sometimes. So for instance, if you look at the highest dose of the Takeda product in phase two, the PASI 75, sorry, the PASI 100, you can see that the PASI 75 is the highest dose of the Takeda product. And in phase two, you can have outliers sometimes. So for instance, if you look at the PASI 75,
effect. So it just doesn't make sense that eventually with adequate target coverage, you wouldn't be able to reach an antibody-like efficacy because with antibodies as you dose down, you will see, you know, web shifts of all the efficacy.
of the expected relationships for PASI 75, 90, and 100. Coming to the UC trial, so I think we probably won't comment in detail on exactly the characteristics of the patients that we have recruited. We have a substantial number of sites.
in multiple countries, pretty standard for the industry. And this looks like a typical internationally-conducted phase two trial. We've conducted it relatively quickly. And that's what it...
looks like the, you know, from a monitoring perspective, what we do will be, as we have pooled blinded data, you can stratify patients for high enrolling sites versus non-high enrolling sites, specific high enrolling countries versus rest of world.
advanced therapy naive versus advanced therapy failure. And what you're looking for is that you see consistency across those stratified analyses in the rates of the different outcome measures. And I feel good about the consistency.
of our data in biologic, naive, and biologic failure in high enrolling countries versus restive world. So I think we're conducting a robust trial. I'm not gonna lay out all the exact patient population characteristics today. You'll see those when the data come out in the second half.
but from a trial monitoring perspective, I'm very pleased with the consistency of the data. Good. Got it. Understood. Super helpful. Thank you guys.
From a trial monitoring perspective, I'm very pleased with the consistency of the data. Understood. Super helpful. Thank you, guys. Thanks, Derek. Thank you, Eric. Thank you, Eric. Thank you, Eric.
The next question comes from Alex Thompson with Stiefel. Please go ahead. Hey, great. Thanks for taking my questions. I think for timelines for the rest of this year, I think previously you had mentioned that you expected O02 data sort of late 3Q, early 4Q, and then the 958 data after that. Just wanted to sort of confirm that those timelines are still what you're expecting. And then maybe for Marty, if you could talk a little bit about what's embedded in your cash runway guidance in terms of spend. Thanks. Yeah. So for a year and a half back your quantities were interrupt the wasn't an overnight question where I took long activated lines.
For S1P1, we've all guided people to second half of the year. So it's going to be sometime late third quarter, early fourth quarter.
And then for the psoriasis trial for 958, fourth quarter. So late fourth quarter, I would probably guide people. Hey, it's Marty. Yeah, so our cash run was expected to carry us into 2025 and what's included in that.
phase one trial for VTX 3232, our CNS directed an LRP3 inhibitor out of that capital, and we expect to be able to produce materials and conduct necessary kind of like pre-phase three trial costs around CMC and things like that. Getting into 2025 obviously does not necessarily get us through.
The next question comes from Chris Shibutani with Goldman Sachs. Please go ahead. Thank you very much. Two questions, if I may. The first, I believe on clinicaltrials.gov with the Phase II psoriasis study, it appears that in the posting that there's a slight change with a 16-week long-term extension arm.
had. You previously commented for duKrava that you expected a negative outcome from the Crohn's disease phase two. This has played out. Can you talk about your impressions and if this has any influence on your thinking going forward on Crohn's? And then secondly with the Tick-Too commercial performance.
They'd recently talked about how that's done relative to Othello. I think they talked about a 40 versus 60% share. How has this performance?
with your expectations and maybe share with us your views updated on the commercial opportunity as a result of how SOTIC-2 is delivering thus far. Thank you.
tox study coverage for up to 16 weeks of therapy, and so the trial was designed with that in mind, and the primary endpoint was and remains week 16. Subsequent to that, we have had sufficient long-term or chronic tox data to extend the duration of treatment beyond the 16 weeks, and we went through the regulatory filing process for that, and the clinicaltrials.gov update indicates that we'll do another year of therapy. So it was just availability of supporting data.
With respect to Crohn's disease and TIK2, I don't think that we always expected that the outcome of the study would be negative. We'd know that with IL-23 antibodies that you need doses that will...
plateau at a high level, past C75 and the 85 to 90% range, you need at least those doses, if not higher, to see efficacy in Crohn's disease. And of course, the SOTIC-2 dose that was studied was well below that and had...
high level, PASSI 75 and the 85 to 90 percent range, you need at least those doses if not higher to see efficacy in Crohn's disease. And of course, the SO-TIQ2 dose that was studied was well below that and had estimated represented, um...
IC50 coverage of about 16 hours and IC90 coverage of zero hours. So no reason to believe that would work in Crohn's disease and sure enough it didn't. We always knew that was what was happening and that we expected the trial to fail and it's a completely different proposition from the hypothesis of our trial where we are studying doses up to 24 hours of IC90 coverage that we think will show class leading efficacy and psoriasis.
will likely show strong efficacy in Crohn's disease as well. So it doesn't change our thinking at all. We completely factored that in. And on the commercial.
Yeah, on the commercial side, you know, we'll keep it brief. So, firstly, you know, just recently hired a head of commercial here, you know, without forward thinking across our trials and, you know, looking beyond the psoriasis trial and other indications as well.
I think this, you know, it has analysis for what it is. First, the analysis is always lagging as it's now being begun our own discussions as part of our commercial planning with prescribers and KOLs. You know, there's a huge amount of excitement in this class of drugs, right? Big, big markets.
you know, an oral which is clearly differentiated from a Tesla. I think the market will grow. It's going to benefit us as we come into the market, as we move along our trials. And I think with a drug, with Tic-2 class, with safe drugs, with efficacy that's comparable but certainly better than what's been shown with Tic-2.
not just with Tesla, but what's the whole prescribing ratio in terms of biologic patients, naive patients, and folks that are switching over from Tesla. Anything else to add, Bill? They're going to have high dose data. And they used the study later this year. So curious on any
You know, in phase one, they had a dose of 12 milligrams BID. Our calculations are that that would give approximately 24 hours of IC50 coverage and still zero hours of IC90 coverage. And I'll remind you of that.
all of us that 78% of patients had skin organ class toxicity on that dose. So it was really not tolerable. So there have been rumors that they're studying 8BID or 10BID or even 12BID.
It's difficult to imagine it's 12BID from a tolerable Z perspective, but even if it is, it's exactly the answer that I gave previously for Crohn's disease. Even at 12BID, it would not give coverage that you would expect to work in inflammatory bowel disease. And then just to remind us what you also see is that...
the effect size with anti-L23 antibodies is larger in Crohn's disease than it is in ulcerative colitis. So you typically see differences between drug and placebo at optimal doses of 20 to 30% in Crohn's disease. The effect size with anti-L23 antibodies is larger in Crohn's disease than it is in ulcerative
studies and ulcerative colitis for induction studies. As I recall, the quotes high dose ducravicitinib study is 40 patients per arm drug and placebo. If they are seeking to show a difference of 14 percent, which I think is the best case scenario, if you had a fully dosed antibody or a TIC-2 inhibitor that has IC90 for 24 hours, you'd be trying to show a 14 percent difference with 40 patients per arm, that's not going to work. So I predict it will fail.
With respect to 2735, this is a peripheral compound. We believe this is the best in class, NLRPT, peripheral molecule out there. So we've done the phase one. We announced the phase one data last year. We've done the talks work. We've done the CMC work to support the phase two trial. What we also very clear about this last discussion was with our focus on driving the phase two trials for tick two with 958 with our focus on the UC trial for 0 or two. We would sort of shift the focus from...
2735 towards the end of the year. Again, this will be a phase two ready molecule. We have previously shared the excitement across a number of disease indications where IL-1 beta and IL-18 have been implicated and a lot of sort of validation from different trials out there in particular on the biologics. So we'll make a decision towards the end of the year with this phase two ready camp on how we proceed with the development, whether it's with the partner, whether we go it alone.
But for now, what we've done is position these as phase 2 AD compounds, focus on delivering on our promise with both trials for UC and for OO2, so just stay tuned for 2735. Great, thanks so much.
as well as in the Ease of Phase 2 Eddy Compounds focus on delivering on our promise with both trials for UC and for OO2. So just stay tuned for 2735. Great, thanks so much. Yeah, you're welcome.
The next question comes from Sam with Life Sci Capital. Please go ahead. Hey, good afternoon, everyone. Thanks for taking my questions. Two quick ones for me. One, on the oral IL-4 receptor alpha program, remind me on the profile that you're looking for in your lead candidate.
And then what target coverage do you think is needed for an oral alpha receptor alpha to be effective? So again, we're not going to go into too much detail on that program, Sam. As you know, we're one of the few folks that has sort of...
embarked upon this challenge. We've disclosed our lead, just a sort of a little, little data on our lead compound in terms of the excitement we have. Obviously, we're going against a extremely successful drug out there, the Pulum app, the Pixen. And so what I would say just stay tuned. We're moving along the lead-up program here. Here.
Could all of the assays in place, you know, we've said that we'll come back to the end of the year and talk a little bit more about this as the program ensures. So stay tuned. Okay. And then just lastly, for the phase one study with GTX 3232, since you plan to take that into neuroimpliatory indications, just curious on how you're thinking about measuring the PD effect and then what you would want to see with that for a scene of strung.
Yeah, good, great question. So, you know, there's really no precedent for, or there's no data for any LRP3 that's been taken into...
phase one or phase one B trial. There was indication that the inflosome compound had been taken and there's no data released from that particular trial. So for us it's really, we think this is the best in class compound. It has a really good CNS Beneturn profile in terms of.
you know, KPUs, the KPUs, the distribution across the CSF, what we expect to be the free fraction in the, in the Tissue fluid in the brain. So our goal for the phase one study, it's a two-part goal. First is to do a phase one study where we look at, of course,
ESS, which is a surrogate for free fraction of the brain, and also surrogate for what you expect in the interstitial fluid in the CNS as well. So that's part one. What we're actually looking at now, and we will disclose our final intent is looking at potentially looking at biomark.
With efficacy, PK in particular looking at exposure in the CSF is a very relevant path forward for the eventual development of this compound in longer phase two studies. But again, the precedent for looking at CSF levels.
and calibrating those to brain labels as well. I think in terms of biomarkers, of course the ultimate biomarker for NLRP3 activity is IL-1 beta, but again we're also be conscious of if and when we go into a disease population, what biomarkers do we expect to modulate in those patients and are they really sort of...
consistent with the duration of these trials. They are really meaningful in terms of what would guide us through a phase two trial. So stay tuned for 3232 news coming out. Of course, we're, as we said, we're gonna dose the phase one healthy volunteers in this quarter. And then we'll talk more about that future of this.
great to get together with you all and address the questions. Very thoughtful and appreciate the interest in our programs.
And so, you know, let's we'll see you guys again in a few months. So thanks again all. And thanks to the team. This concludes today's Ventex Biosciences first quarter 2023 earnings conference call. Please disconnect your line at this time and have a wonderful day.