Operator
Good day, ladies and gentlemen, and thank you for joining CymaBay's Phase III RESPONSE trial top line results conference call. [Operator Instructions] Please be advised that the call will be recorded at the company's request. It is also being webcast live on the Investors section at the CymaBay website at www.cymabay.com.
Now I'd like to turn the call over to Mr. Paul Quinlan, General Counsel at CymaBay. Thank you, sir. Please go ahead.
Paul Quinlan
Thank you, operator. This morning, we issued a press release announcing top line results from the Phase III pivotal RESPONSE trial evaluating seladelpar in patients with primary biliary cholangitis, or PBC. You can access that release along with slides that support our discussion today on our website under the Investors tab.
Joining me on the call today are Sujal Shah, Chief Executive Officer; Chuck McWherter, Chief Scientific Officer and President, R&D; and Dr. Gideon Hirschfield, Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Center for liver disease. Following our prepared remarks, we will open the call for Q&A.
Before we begin, I'd like to remind everyone that statements made during this conference call, including the Q&A session relating to CymaBay's expected future performance, business prospects, events or plans, including clinical plans, regulatory approvals, anticipated time line, cash runway and planning for commercialization are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based on reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors.
The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Participants are directed to the cautionary statements set forth in today's press release as well as the risk factors set forth in CymaBay's quarterly and annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. This conference call is the property of CymaBay, and any recording or rebroadcast is expressly prohibited without the written consent of CymaBay. At this time, I'd like to remind you again that you may access the slides we will be referring to during this call under the Investors tab of www.cymabay.com.
And now I'll turn the call over to Sujal.
Sujal Shah
Thank you, Paul. While we are eager to get right into the exciting top line results from RESPONSE, we feel it is appropriate to start this call by acknowledging the tireless efforts and sacrifices of everyone that has been part of this incredible journey to bring a novel groundbreaking potential treatment to patients with PBC. We want to thank patients as well as their family members and caregivers, patient advocacy groups, investigators and their staff, our partners across every part of our operations, our investors and the many people past and present at CymaBay, who have shown the utmost dedication to this important work.
We are thrilled today to announce that seladelpar met its primary and 2 key secondary endpoints with high statistical significance in the Phase III pivotal RESPONSE trial for patients with PBC, consistent with what we have observed in the past, seladelpar 10 milligrams had a significant effect on lowering and even normalizing markers of cholestasis, that have been associated with risk of disease progression, while also significantly reducing pruritus or itch when compared to placebo. Seladelpar also appeared to be safe and well tolerated in the study.
As we turn our attention to discussions and filings with regulators, we believe seladelpar has the potential to be the first ever approved treatment for patients with PBC to significantly improve markers of disease activity and symptoms. Our goal is to help patients have longer and better lives, and we are excited to now move another pivotal step forward towards this milestone. I'll first turn the call over to Chuck to walk through the results in greater detail. Before taking questions, I will also ask Dr. Gideon Hirschfield to provide his reflections on response and the potential impact seladelpar may have in the treatment landscape for PBC. Chuck?
Charles McWherter
Good morning, everyone, and thank you for joining Echoing Sujal's comments, I'm thrilled to have this opportunity to walk you through the top line results from RESPONSE, pivotal study that we believe supports advancing seladelpar through the regulatory process as we look to bring what has the potential to be a groundbreaking treatment alternative for patients with PBC. I could not be more pleased with the conduct and quality of this study and the entire development program to support registration of seladelpar as potentially the only PBC treatment to both significantly improve markers of cholestasis, and reduce pruritus.
As we walk through the slide deck posted to the Investors section of our website, I'll pause first on the safe harbor statement on Slide 1. To remind you once again that during today's call, we may make forward-looking statements and thus advise you to review the risk factors inherent in our operations as set forth on this slide and in our SEC filings.
Let's now turn to Slide 2 of the presentation. This shows a graphic of the RESPONSE study schema. RESPONSE was a double-blind, placebo-controlled global study of 1-year duration that randomized 193 PBC patients to seladelpar 10 milligrams or placebo once daily. Eligible patients with the diagnosis of PBC had an inadequate response or intolerance to ursodeoxycholic acid or UDCA, with serum alkaline phosphatase levels greater than or equal to 1.67x the upper limit of normal or ULN after at least 12 months of treatment.
Primary outcome measure was the responder rate defined as a patient who achieved an ALP level less than 1.67x ULN with a 15% or greater decrease in ALP and normal levels of total bilirubin after 52 weeks. Secondary outcome measures were the proportion of patients with ALP less than or equal to the ULN at 12 months and the change from baseline at 6 months and the patient reported level of pruritus as assessed using the numerical rating scale or NRS, in those patients with a baseline NRS greater than equal to 4. The NRS is a scale of 0 representing no itch to 10, which is the worst imaginable itch.
As a reminder, patients completing response have the opportunity to roll over into the long-term open-label ASSURE safety study, where we have collected data to support registration. At this time, there are over 300 patients enrolled in ASSURE, including more than 95% of patients completing response at sites where ASSURE was active, they have elected to enroll and ASSURE.
Moving now to Slide 3. We have included select baseline demographics, including baseline variables that comprise our primary and 2 key secondary endpoints. The overall population was well balanced across treatment groups, consistent with our prior studies evaluating seladelpar as a second-line treatment in patients with an inadequate response or intolerance to UDCA. A majority of patients were women, average age in the mid-50s and most patients were inadequate responders to UDCA versus the 5% to 6% being intolerant. The mean ALP was about 314 units per liter and nearly identical in both groups. The mean value and response is higher by about 25 units per liter than our prior ENHANCE study and was in line with that of our previous open-label Phase II study. Most patients in the study had normal total bilirubin at baseline with means of 0.74 and 0.77 milligrams per deciliter. About 37% of the patients randomized at an NRS pruritus score greater than or equal to 4 at baseline with the average being above 6.
Turning now to Slide 4. We highlight the results of the primary composite endpoint that was used by FDA for accelerated approval of medical acid, the only approved second-line treatment on the market. In response, 62% of the patients on seladelpar 10 milligrams or 6 out of 10 met the primary composite endpoint which is related again to the serum alkaline phosphatase and bilirubin levels at 12 months versus 20% on placebo. This treatment difference was highly statistically significant with a p-value less than 0.0001.
Now moving on to Slide 5. The lease squares mean percent reduction in alkaline phosphatase is shown over 12 months. At the 12-month time point, the reduction in ALP was 42.4% in the seladelpar group versus 4.3% in the placebo group. This represents a decrease in ALP that is about tenfold greater and that's seen in the placebo group. The treatment differences were highly significant at all time points and consistent with what we have observed for seladelpar 10 milligrams across this in all prior studies. As a reminder, reduction in ALP is independent of baseline ALP levels.
On Slide 6, you can see the anti-cholestatic effect of seladelpar manifested in the key secondary endpoint of normalization at 12 months. Here, 25% of patients or 1 out of 4 on seladelpar versus none on placebo had normal or lower levels of alkaline phosphatase at 12 months despite the average alkaline phosphatase level starting 2.7x above the upper limit of normal. Once again, this result was highly statistically significant with a p-value less than 0.0001 versus placebo. Turning now to pruritus, we believe the results obtained in response has the potential to be a defining differentiator for seladelpar.
On Slide 7, we display results with the key secondary end point of least squares mean change from baseline in NRS at 6 months in those patients with an NRS at entry of 4 or greater. Seladelpar treated patients had a mean reduction of 3.2 points in NRS compared to 1.7 points in the placebo group, again at 6 months with a p-value for the treatment comparison less than 0.005. Seladelpar has demonstrated statistically significant reduction in pruritus now in 2 placebo-controlled studies: first in ENHANCE and now in the RESPONSE trial.
Moving to the last slide to recap our presentation today. Seladelpar met all the prespecified trial endpoints with high statistical significance. ALP reductions, the primary composite endpoint and ALP normalization were all meaningful and highly significant in patients with clinically significant baseline itch, seladelpar had meaningful and highly significant reductions in patient reported pruritus intensity measured with an electronic diary.
Overall, safety was comparable between placebo and seladelpar groups and was consistent with previous studies, treatment-emergent adverse events, serious adverse events and patient discontinuations were generally balanced across the treatment and placebo group. There were no treatment-related serious adverse events in the study, and we look forward to sharing more details on the overall efficacy as well as safety results from response at an upcoming medical meeting.
We have been fortunate to have the guidance of many experts in the PBC fields, including from thought leaders like Dr. Gideon Hirschfield, who has been involved with clinical development in PBC for many years, and has been involved in our program since our earlier studies.
I'll turn it over now to Gideon.
Gideon Hirschfield
Thank you, Chuck, and thank you, CymaBay for asking me to join this call today, allowing me to offer some independent clinical commentary on the results you have just announced. First of all, I'd like to echo the sentiment of Sujal in his role on behalf of everyone working for the trial sponsor in thanking all those people living with PBC who took part in the study. I think their involvement in this controlled trial of a new and exciting liver therapeutic is a true testament to the fact that we all recognize the ongoing unmet need for new therapies for our patients with PBC, that in particular, a safe biochemically potent and improve symptoms. It is in this context that we should look at these results now announced from the RESPONSE trial.
As a treating physician, being able to tell patients that the trial analysis confirms this new therapy is evidentially biochemically potent and will improve troublesome etch is very important. Our treatment goals for PBC are ambitious, and we seek medications that are designed to prevent progression of liver disease and improve patient quality of life. The response data Chuck provided and which I listened to earnestly is an extension of a substantial data set already generated for seladelpar in the proposed treatment of PBC. Treating physicians worldwide are seeking licensed improved drug choices to those already approved therapies we use at present. It is fair to say that the results now announced from this pivotal Phase III global PBC study are in my own opinion, very good news for patients.
I genuinely look forward to CymaBay sharing more information from this landmark trial, but my take-homes just from listening to the data Chuck presented today are: one, 6 out of 10 treated patients met the very robust, accepted primary composite endpoint we have come to all agree on represents treatment success; two, substantial, at least 40% declines in individual ALP responses are noted on seladelpar 10 milligrams daily; three, after only 12 months, already 1 in 4 treated patients had normal ALP values; four, for patients living with moderate to severe pruritus, a really dreadful and underserved symptom, seladelpar improved pruritus in a robust, sustained and statistically significant manner.
The safety of any new medication is paramount to patients and treating clinicians. I'm, therefore, additionally reassured with the safety profile being reported today. Although naturally, there is so much more to delve into from this clinical trial, what I can conclude confidently is that patients and their treating clinicians will welcome the findings announced today enormously. I'm very happy later on to contribute further insights as a treating physician in response to any relevant clinical questions.
But for now, I will hand over to Sujal for his closing comments.
Sujal Shah
Thank you, Gideon. We are thrilled for what this data means for patients with PBC. In the coming months, we will continue to analyze the full data set and look forward to sharing more at an upcoming medical meeting and eventually in publication. Our priority now will shift to regulatory discussions and filings, while we also accelerate our medical affairs activities and pre-commercial preparation. We believe the RESPONSE results represent a potential breakthrough for patients with PBC, offering the potential to reduce the risk of disease progression, while also improving symptoms and quality of life.
Our commitment to patients with PBC continues beyond response as we generate additional safety and efficacy data in the ASSURE open-label long-term study and the IDEAL Phase III study evaluating seladelpar effects on ALP normalization in patients with an ALP between 1 and 1.67x the upper limit of normal and as we advance the outcome study required for accelerated conditional approval.
Seladelpar has the potential to be the first ever delpar approved, and we believe an opportunity to lead the advancement of PBC treatment offering benefits beyond that of options available or in development today.
Thank you once again for joining us today, and we look forward to sharing much more with you from RESPONSE and other studies in the months and years ahead. We're happy now to take questions. Operator?
Operator
[Operator Instructions] Our first question comes from the line of Yasmeen Rahimi with Piper Sandler.
Yasmeen Rahimi
My congratulations to this data. One question and 1 follow-up. The first one is, could you comment on the placebo response in the composite endpoint why it might have driven to be a little higher than expected. I would also love to get color from Dr. Hirschfield in regards to his views and colleagues views whether they look at placebo adjusted rate or they look at the drug arm rate as they evaluate?
And then the second question is, congrats on achieving statistical separation in itch at month 6. Another endpoint was week 52. Could you maybe comment on whether you picked up also statistical separation at the 52-week time point, and we'll jump back into the queue and congrats again.
Sujal Shah
Thank you, Yas. I appreciate the questions. We'll address them a bit in reverse. I'll start off by talking about the itch endpoint, of course, the prespecified endpoint in the protocol was to look at the NRS score at 6 months versus placebo, where you saw in the data set that Chuck went over, we saw high statistical significance in terms of the reductions you observed with seladelpar treatment.
We did look at 12 months. And while we look forward to sharing much more data around itch at an upcoming medical meeting and in publications, I can tell you the statistical significance remains at 12 months versus placebo as well. Let's talk a little bit more about placebo ALP reductions, and maybe I'll hand it over to Chuck, who can then pass it to Dr. Hirschfield.
Charles McWherter
Thank you, Yasmeen. I think it's important to recognize that the ALP response in the seladelpar group was strong, and really in line with our expectations from our prior studies. In addition to the strong response on the composite, we saw the ALP normalization entirely in the seladelpar group and none in placebo, and the mean ALP percent reduction in the seladelpar group pointed to a really strong cholestatic benefit that was not seen in the placebo response on ALP.
So in line, if you think about the placebo effect on ALP, the composite response in that group ended up slightly higher, as you mentioned, than that we've seen in prior trials. We think likely due to a random effect of having more patients closer to the 1.67x ULN threshold. Again, looking at the mean 4% ALP reduction of placebo group versus the mean 42% ALP reduction and 25% normalization rate. You can see that patients on seladelpar are getting a significant benefit in a cholestatic marker versus placebo.
Also important to mention that in spite of those comments, the overall mean ALP at baseline was balanced between the 2 arms. And we think these results are really an exciting outcome for patients that confirm the profile seladelpar seen in previous studies very consistent. And we hit on all 3 endpoints as we mentioned. So we're really excited to get these data to regulators.
I'll hand it over to Gideon.
Gideon Hirschfield
Yes, thanks. I mean, I think I should comment as a clinician and say that I look at the totality of the data, and I also look at it in the context of my clinical practice. So I know that patients on UDCA who don't respond in clinical practice remain nonresponders and need second-line treatments.
So when I look at the data and I think other clinicians, I don't think we will focus hugely on a placebo response in 1 single trial. I think we'll put it into the context of our clinical practice. We'll put it into the context of what we've learned from global PBC and U.K. PBC cohort studies about the importance of insufficient response and the fact that it usually remains insufficient response for patients and we'll put it into the context of the prior data of the development of new drugs in PBC.
And I would agree with Chuck. What I looked at really was the change in alkaline phosphatase which is notably exactly in line with what was expected and the placebo change was tiny. And additionally, the quite marked effect on pruritus which clearly was not seen in the placebo group. So although I think there's a lot more to learn from the deep dive, which no doubt CymaBay will be spending many hours and months going through so we understand it. As a treating clinician, I think the efficacy is apparent.
Yasmeen Rahimi
I'll jump back into the queue.
Operator
Our next question comes from the line of Steven Seedhouse with Raymond James.
Steven Seedhouse
Congratulations on the successful outcome. Two questions, actually. First is just can you comment on the time line to filing here in both U.S. and I guess, Europe, most importantly? And then second, on the placebo response rate for the primary responder endpoint. Did that fluctuate at all throughout the study? And if so, what was the range of that placebo response across, I guess, the month 3 to month 12 assessments?
Sujal Shah
Appreciate the question, Steve. Thank you. So ultimately, our plans here are to move rapidly and efficiently towards completing and submitting quality regulatory packages, both in the U.S., the U.K. and in Europe. It's a bit too early for us to set guidance on this, but I can tell you, 100% of our focus here at the company is now to get seladelpar in the hands of as many patients that will benefit. So we've prioritized a number of different work streams that have, in fact, been ongoing since before sharing these top line results.
Fundamentally, we believe RESPONSE will allow us to register seladelpar in the U.S., U.K. and in Europe. And so again, our plan is to move as quickly as we can towards those next steps.
Coming back a bit to the placebo response, I think very important once again to recognize, what you see on Slide 5, the percent change, the relative change in ALP over time, I think tells you all that you need to know, placebo, about 4% throughout the study and up to 12 months. 42% with seladelpar, very rapid, robust declines immediately and sustained out to 12 months shows you that within the placebo group on the composite, as Chuck mentioned, really, it takes just a few patients that are in and around the 1.67 bar at start to become responders on that end point.
And so I think very clear to see the differentiation in 6 out of 10 patients on seladelpar 10 milligrams meeting the endpoint overall. So nothing really that I'd comment on other than to suggest as I think even Gideon has disclosed, it's really just a small set of numbers here. Remember, placebo patients are predominant patients that remain on UDCA. Treatment arm is predominantly patients taking seladelpar 10 milligrams on top of UDCA. So the real question is how many additional patients can you drive to go and how many additional patients can you normalize. And on that latter, again, as we see very strikingly, 1 out of 4 patients on seladelpar on top of UDCA are normalized in their ALP, whereas none are for those patients that simply remain on UDCA.
Steven Seedhouse
If I could just follow up quickly. I meant to ask, is your understanding that this data package will be sufficient for your partner to file in Japan as well?
Sujal Shah
No, I appreciate that as well, Steve. So Kaken, obviously, is moving forward with the seladelpar program in Japan. There are additional studies required in Japan. But of course, these do have the opportunity to leverage the entirety of the data set we've generated inclusive of RESPONSE.
Operator
Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald.
Kristen Kluska
Let me also add my congratulations on this data set. So just given from a real-world aspect, it seems like there's a lot of added new focus on normalizing ALP and of course, pruritus. So I was hoping if you can kind of contextualize for us essentially what this data mean. So what is a 3.2 decline entail for patients is rapidly on itch? And then on these measures, what does standard of care usually show, if anything at all?
Sujal Shah
Yes. Thank you for the question, Kristen. Perhaps I can invite Gideon in fact, to respond. I can tell you at least at the onset, UDCA, at least with respect to itch, has never been demonstrated to benefit itch reduction in patients with PBC. So we do, as you mentioned, believe these data are potentially quite groundbreaking as the only second-line treatment available today can actually cause or worsen itch. That's a bit of the backdrop that patients face today with respect to the treatment alternatives available to them.
Gideon, perhaps you can comment a bit more on the importance around normalization and your perspectives once again on itch.
Gideon Hirschfield
Yes. Thank you. And I think it's a really important question. I think the field as a whole is moving towards aspirational targets and our treatments. We're looking for our patients to get as close to normal outpost and improvements in quality of life. So I think the data here contributes to that aspiration that there'll be new therapies for our patients.
Itch is a really terrible symptom. In clinical practice in North America, there are very limited options for the treatment. And I think Sujal is right that whilst there's been advances in second-line therapy, in PBC, the currently approved therapy definitely has a pruritus signal where the itch gets worse, and that's a really major issue for patients in terms of tolerability and use.
It is always very hard to translate quantitative measures of a symptom into clinically significant changes. But I think that the changes that are presented in that slide are clinically significant for patients. I think the way that the pruritus was measured in the study was robust is reproducible. It was done in a very objective way. And therefore, it really is quite pleasing for patients to actually see what they've been reporting to us that there's demonstrable improvements in a symptom that really reduces their quality of life and contribute to their fatigue and contribute to their sleep disruption. So I think it's highly positive and very encouraging for patients.
Kristen Kluska
Great. And I certainly respect that you're planning to share additional data at a medical conference, but I was wondering if you can just comment on what endpoints or measurements we may learn about in the future without, of course, sharing the specific data?
Charles McWherter
Yes. Well, thank you. Of course, there's a range of liver biochemistry that's available to us additional cholestatic markers. And importantly, we believe markers of liver injury, which are tied into not only the accumulation of the effects of bile acids due to cholestasis, but also the inflammation and fibrosis. So the liver injury markers are something that will be part of the data set that we'll look forward to sharing. There's a whole number of other things that have been collected in the study that I think will be very of great interest, and I think it's exciting to be able to share, but we're still doing some of that analysis now.
Sujal Shah
I appreciate the question, Kristen. There's much more obviously, that we're excited to dig into. I think these top line data really just scratch the surface, but we'll look forward to having that opportunity to share much more at an upcoming medical meeting.
Operator
Our next question comes from the line of Patrick Dolezal with Life Science Capital.
Patrick Dolezal
So in light of the pruritus hit, just curious how you're thinking about how these data might show up in the label. Is there any case for an indication labeling versus data in the clinical trial section, and if not now, might you try to get that with future studies or modification of existing studies.
And then the second question is just on ALP reductions over time. Obviously, in the open-label extension through 2 years, you see deepening of effects. Just curious if you can provide context on how those data are maturing as more patients are reaching further out time points?
Sujal Shah
I appreciate the questions, Patrick. So first, with respect to pruritus, I will tell you that we have consistently seen reductions in itch with seladelpar, whether you look at our Phase II data, obviously, open label, but nevertheless, VAS scores, 5D-itch PBC-40 questionnaires around pruritus, all consistently showing reduction in itch. ENHANCE, of course, with the prespecified endpoint, looking at 3 months versus baseline statistically significant reduction in itch, and yet again, here we see the same.
And so our feeling is we have now 2 separate global Phase III studies in which we've hit this prespecified endpoint on reduction in itch, it is certainly our aspiration to take these data sets to regulators seeking an indication not just to treat PBC, but also to treat PBC-related itch. Clearly, there are many ways for us to be able to show this differentiation, as you mentioned, inclusive of even simply having the data in the data section of the label, showing this benefit, we think, is a clear differentiator for seladelpar as we begin to do much more work from a medical affairs perspective and a pre-commercial planning perspective as well.
I think Chuck will add a few more additional comments.
Charles McWherter
Well, I wanted to move to your question about the the duration and the increase in ALP response that we have seen in our 2-year study, which I think you're alluding to, Patrick, in that study, we had seen a 45% reduction at 1 year, which increased in those completing 2 years to just about 50%.
It really encourages us because as we mentioned on the call -- earlier in the call, we have more than 300 patients currently in ASSURE. It really is going to provide us, I believe, with a very rich opportunity to understand both the safety and the efficacy effects over time. So we haven't read that out yet. That's continuing to occur. We'll submit that data, of course, with our NDA, but even post NDA and if we're successful post marketing, we'll continue to collect data out of that study to examine not just alkaline phosphatase response, but all the liver biochemistry, the liver injury I mentioned, but we also collect data on liver stiffness and a variety of other features, including pruritus as well. So we intend to be able to continue to share with the medical community, the long-term effects of seladelpar in patients in this population.
Patrick Dolezal
Super helpful. And 1 more, actually, if you don't mind. Could you just comment on kind of the range of [indiscernible] values in terms of absolute for participants that would be expected in this study kind of both in between patients and also just within a patient kind of how that variability changes how there is there variability or is it over time?
Sujal Shah
Yes. I think, Patrick, as part of what you're asking is what's the dispersion in terms of baseline ALP in patients. Obviously, we stratified patients those that are above 350 units per liter as well as those that are below in order to get a balance mean. And so I think the key thing to focus on here is the balanced mean was, in fact, we did have a balanced mean between placebo and treatment arm. Of course, there can be patients at a variety of different levels of both ALP as well as bilirubin impacting the composite.
Again, if I take you back to the percent change, which is independent of baseline ALP, it tells you, I think, what you need to recognize with respect to the treatment effects here, 42% mean reductions on seladelpar 10 milligrams versus 4% on placebo. And if you look at the [ arrow ] bars on Slide 5 of the presentation, they're very tight. So most of the placebo patients are really within that tight band as are the patients on seladelpar in that type 42% drop band. Of course, you can have some people respond more or less. These are means -- but I think it's a very tight sort of response that we see.
Patrick Dolezal
Super helpful. And congrats again. .
Operator
Our next question comes from the line of Julian Harrison with BTIG.
Julian Harrison
Let me add my congratulations on the fantastic results. First, I'm wondering if there was a meaningful subset of PBC patients in response with compensated cirrhosis. And could we maybe expect the subgroup analysis there sometime in the future? And then you've seen a slight benefit on LDL-C and prior data sets that compares favorably to a cholesterol liability with a beta-cholic acid. So I'm just curious if you saw something directionally consistent in RESPONSE.
Sujal Shah
Yes. Thank you for both questions there. We saw very consistent data in -- with respect to treatment alternatives here with seladelpar on each of these. First, with respect to cirrhotics, there were a subset of patients in this study that were compensated cirrhotics. I'll remind you in prior studies, about 20% of our patients had compensated cirrhosis. So this will be another opportunity for us to dig deeper and share some data at upcoming medical meetings. You should expect us, in fact, to see this.
I'll remind you that what we've seen historically is comparable efficacy and safety in compensated cirrhotics. So we look forward to looking into these data and sharing that in the future as well. And again, with respect to LDL-C, known mechanism of PPAR delta to drive fatty acid oxidation, again, consistently, we've seen across a number of different patient populations, mixed dyslipidemics as well as patients with PBC and even NASH reductions in LDL cholesterol. This again will be the subject of future additional presentations.
Operator
Our next question comes from the line of Ellie Merle with UBS.
Eliana Merle
Congrats on the data. Maybe just in terms of thinking about how the efficacy data could show up on the table. I guess how should we think about the different scenarios around how this could be depicted, particularly across the different trials and across different endpoints such as the composite response and ALP reductions and ALP normalization, particularly with respect to ALP normalization, just given potentially changing treatment guidelines focusing on the normalization. And then I have a follow-up.
Charles McWherter
Yes. Well, thank you, Ellie. Of course, it's a little premature to speak with a lot of specificity about how data is going to appear in the label, if we get to a label. And that's the threshold to be to be crossed. I think I would say just generally, as you well know, trial data appears in the label as the results that you developed. So I would expect that it will report on what the prespecified endpoints are.
So I don't -- beyond that, there'll be an opportunity to perhaps share some other aspects of treatment response. But in general, I think you focus really on what you study. And I wouldn't expect, in our case, to see much different.
Sujal Shah
The only thing I'll add to that, Ellie, thanks for the question is, the primary endpoint as well as the 2 key secondaries were part of our statistical hierarchy. So we would expect to see both the composite response as well as normalization data -- that would be our intention, obviously, in terms of what shows up in the label, inclusive now of hitting statistical significance on itch. So what you see here is exactly what we would intend to have in the label. Again, as Chuck mentioned, those upcoming for us as we file and have discussions with regulators.
Eliana Merle
Great. And then just for Dr. Hirschfield. I guess, how do you think about sort of high level, maybe how you would approach comparing seladelpar's efficacy versus others such as elafibranor across the various data points such as the composite response rate, ALP reduction, pruritus. And I guess, in the real world, what do you think will matter most to physicians in practice?
Charles McWherter
Yes. I mean I think it's a bit early to do that. I don't have sufficient data from either seladelpar or elafibranor to do head-to-head comparisons. And no doubt, those kind of comparisons will come when more. There's more bigger data reveal. I think what is apparent is that there's good normalization in seladelpar. There's a very robust ALPhos response. There's a very good composite endpoint response, which is exactly as expected and is better than the current approved therapies, and notably, there is statistical significance on pruritus.
So on face value, there are definitely some features of the data that's been presented today that stand out. But I mean, there's just a lot more for the community to look at and no doubt that will become available in the coming months at relevant medical meetings and will be scrutinized. I think as clinicians, what we're looking for is simplicity, we're looking for potency, conditions like high potent drugs. They like high potent drugs that have defined clear responses, a significant knowledge that your patient will improve their alkaline phosphatase and you can tell them that they will improve their itch. I think those are all factors that treating physicians in North America and beyond value very highly.
And on top of that, they value very highly understanding a broad development pathway for a new drug in a disease area such as PBC. So they look at the totality of the data for new drugs. And as regards seladelpar, they'll be able to look at other clinical trials and the long-term safety extensions with also, as was alluded to, the hope that, in fact, there are better treatment responses with duration of therapy, and given the tolerability profile, they're going to be comfortable to imagine that their patients are going to like to take a drug such as seladelpar.
But I mean, I think -- those are just high-level thoughts. There's a lot more to reveal for all new drugs in development and clinicians look forward to seeing that data and commenting at that point.
Operator
Our next question comes from the line of Seamus Fernandez with Guggenheim.
Seamus Fernandez
And congrats on the data. Just a couple of quick ones. First, just as you look at the data as it's presented so far, particularly on the ALP reductions, overall. Can you just give us your thoughts on the prospects of IDEAL and kind of the current powering assumptions with the sort of 75 patients that are being recruited into that study. And perhaps maybe just in addition to that, how we should think about the prospect of showing an itch benefit in that patient population. Do you think it's worth pursuing itch in that patient population a little bit more aggressively, whether it be by increasing the powering of the study or is really the focus here in IDEAL normalization of ALP?
And then the second question, just hoping to put into context the prospective kind of launch opportunity that you see here. This is maybe a bit of a dual question for Sujal, and also for Dr. Gideon. Maybe just as in terms of switch opportunity, second-line opportunity, maybe you could just frame what you see as kind of the initial target patient population and then the expanded population. And Dr. Gideon, maybe if you could just put in context for us, a little bit of the early launch trajectory of Ocaliva, which actually rose very, very quickly in that early phase. And I think a lot of -- there may be some confusion as to whether or not those were truly PBC patients versus NASH patients getting treated early. Just hoping that you could put a little bit of context around your own experience of using Ocaliva and then the limitations of Ocaliva that kind of capped the growth of that asset.
Charles McWherter
Seamus, this is Chuck. So thank you for mentioning IDEAL. I think this is an exciting new program that really is in line with the aspirations across the field to normalize biochemistry, especially alkaline phosphatase since patients with normal levels have been shown in retrospective analysis to have decreased risk for progression of their disease. And after all, that's the goal for all patients really is to stop the disease in its tracks and then, of course, offer them the benefit of symptom relief.
I would say with respect to the IDEAL study, we're very confident in the design and the execution, and that's really -- the foundation for that is the data that we represented here today, and we've seen in prior studies, over 40% reductions in alkaline phosphatase with very minimal changes in placebos, usually around single digit -- low single-digit percentages. That says to us that a 40% or greater reduction in ALPhos, if you're in the range between 1 and 1.67x upper of normal is extremely promising in terms of how many patients will normalize versus how many in the placebo group would do so. And of course, we -- we've learned a lot in our clinical conduct across our program, and we know how to stratify. So we'll stratify to make sure we have balance and guarantee that we have a strong treatment difference between the groups.
In terms of itch in the study, that is something that we're collecting. I think the results that we've reported here today in conjunction with what we found in response and even in the open label study improvement in itch out to a year as well, just as a consistent pattern that in this population with lower levels of alkaline phosphatase, they do carry itch as a symptom as a burden. So being able to address that and assess that. And this study is something that we look forward to. It remains to be seen what the results are, but it's something that we felt was important to include as a secondary endpoint in the study.
Sujal Shah
And Seamus, maybe I'll start off before I hand it over to Gideon for some additional perspectives. You asked a little bit about prospective launch opportunity. This is, I think, really well underappreciated from where we are. These data allow us now to forge ahead with regulators and begin to start thinking about patient populations that can benefit from seladelpar, which we think is quite a wide array.
First and foremost, the patients at highest risk of progression, effectively the population we've enrolled in response and enhance. Our patients that are in need of a better second-line treatment, a need of a better treatment to drive greater overall response as well as normalization of biochemistries, which is what we've seen here in this RESPONSE top line data, but also in need of relieving symptom burg and reducing itch. This is really a key unmet need. And so for those patients, this clearly sets up from our perspective as a potential to be the preferred second-line treatment alternative across that higher-risk population.
When we move from there, it's the population and IDEAL, as Chuck just described, those patients that never normalize biochemistries on UDCA as first-line treatment are, in fact, at higher risk than those that fully normalize. And our ability then in the second phase to see expanded potential use of seladelpar, if we're successful in that broader patient population, we think really sets up for a very significant commercial opportunity, an opportunity to really change the lives of many patients with PBC.
You can do all of that before you even think about anyone switching current second-line treatment. The opportunity is quite large even without patients that may switch. Of course, we recognize that patients that are responding well to current second line and not having symptom burden and symptom exacerbation, not likely to move over. But as some of those patients potentially eventually have any sort of safety issues or perhaps even begin to develop itch or exacerbate itch. Of course, we think that seladelpar's profile has the potential to address some of this as well.
Gideon, I don't know if you had anything to add to that or succinctly, I want to give your perspective.
Gideon Hirschfield
Yes, I think that's an appropriate summary of the situation. So as a treating clinician clearly, there'll be a group of patients who I see and I diagnosed who are young, just like the -- if you look at the demographics here the average age the patient is in the mid-50s, which suggest that they probably had the disease and diagnosed early. So there'll be that group of patients that I'll see and I'll see in clinic, and I'll tell them, I've got [ URSO ], but if you need I've got a second-line therapy, which will be potent by chemical and from a symptom perspective. So I think that's a very important population that patients who've never had second-line treatment.
Of the patients on second-line treatment, then, of course, there is a significant number of them who haven't biochemically responded enough, and there is a proportion of them who tolerate a pruritus burden from obeticholic acid, which is simply that's how a obeticholic acid works, and that's 1 of the the challenges of obeticholic acid as is perhaps changes to lipids.
So for that group of patients as a treating clinician in -- particularly in North America, I'm going to be encouraged to think I'll have an alternative, which is more potent and improves profiles of symptoms and other metabolic risks. So I think it's pretty clear how this will sort of be assessed by clinicians I agree with Sujal, patients who are already on second-line treatment and who are happy, of course, that won't be our target.
And then overall, I totally agree that really what we hope for is treating clinicians is to expand the number of patients who go on to second-line treatment, because our goal is really to prevent any progression of liver disease and their symptoms over the long term. And I think there's a whole group of patients with PBC who should be treated with more effective treatments, as evidenced by the trial data and as evidenced by the efforts to get more trial data in a broader population.
Operator
Our next question comes from the line of Jay Olson with Oppenheimer & Company.
Jay Olson
Congrats on these results. Now that we have a Phase III study that successfully demonstrates ALP normalization and improvement pruritus. Can you talk about how these results might impact PBC treatment guidelines with regards to biochemical normalization and pruritus? And then as a follow-up, can you please share any potential read across from these results to the IDEAL study and the potential to impact treatment guidelines in a milder PBC population?
Charles McWherter
Well, thank you for the question, Jay. And of course, it's not our responsibility to write guidelines that we leave that to the medical experts. But of course, it's an area of great interest to us, really our role in this is really to develop the evidence. And so that's the reason that we conduct RESPONSE. We provide the evidence on normalization and that fits in with the broader evaluation of groups like Global PBC, U.K. PBC, many national registries looking at the relationship, for example, of normalization to outcomes for patients, both transplant death and even liver-related adverse events.
In IDEAL, of course, we want to, as in response, provide the evidence is it possible to achieve normalization with a safe effective therapy for patients who are in that range of alkaline phosphatase where currently, they're in a wait to fail mode. Basically, they're not recommended for guidelines. There may be issues with reimbursement. If we can provide the evidence and then the medical community will assimilate and digest and understand and put that together with what's known from epidemiology and disease progression risk factors. It could be that, that will help the trend that we're seeing where experts are interested. They're discussing -- there's publications around normalizing alkaline phosphatase. That's really our role is to gather the evidence around a treatment that might be able to do that.
Maybe Gideon might want to offer...
Gideon Hirschfield
I mean so I think what the efforts of the big PBC registry, Global PBC and U.K. PBC is to understanding greater debt how to be more aspirational and to provide the robustness that those people who write guidelines are looking for. And I think that we can be confident that our data sets are showing that there is justification to rethink the treatment goals in PBC and that patients can expect that because of the data that comes out from these registry studies that they're treating clinicians should be thinking about, why can't I get your blood test to normal or near normal. Why can't I improve your itch with a drug that also treats your PBC?
So I think that's from the academic community is our goal. Then clearly, it's important that sponsors then do studies of their drugs in the defined populations so that we can go back to our patients and say, we've brought 2 sources of evidence together our cross center retrospective and prospective analysis and then some controlled data with interventions. And that will give patients and their treating clinicians the confidence to not only aspire to what hopefully will become generally accepted treatment goals, but to have to -- but the choice of drugs will be based on evidence and efficacy. And so the next few years are going to be exciting, and it's a clear prediction that the number of patients on second-line treatment in PBC will grow.
Operator
Our next question comes from the line of Andy Hsieh with William Blair.
Tsan-Yu Hsieh
Great. Let me add congratulations to everyone at CymaBay. It's nice to see your perseverance paying off. So regarding the primary endpoint, I'm just wondering if you can help us [ become below ] that a little bit. How should we think about the individual components as you kind of look across the seladelpar arm and the placebo arm?
Sujal Shah
Appreciate the question, Andy. And just obviously, to highlight that there'll be more here we're able to share as we dig deeper and look to present these data. Obviously, the primary endpoint includes a patient needing to have an ALP below 1.67 with at least a 15% drop in ALP and normal bilirubin at 12 months. So first, I'll maybe take it a bit in reverse as you see in some of the baseline characteristics that we shared, the mean bilirubin, total bilirubin is actually in the normal range, but certainly, patients can have bilirubin above normal.
And so we're excited at some point to share more of the data around the differences in response between seladelpar and placebo groups with respect to that specific component. Again, today, I would simply guide you to the publications of our Phase II data and ENHANCE to get some idea of what we have typically seen with seladelpar, again, we'll look forward to sharing more specifics around the impact on bilirubin with seladelpar versus placebo.
15% reduction. Again, that's a threshold required to be a responder. You can look clearly at the time course of the percent change in ALP that we shared here today in the slide specifically as we mentioned, only about a 4.4% reduction over the 12-month period, really somewhat consistent with placebo at the initiation all the way through 12 months versus this 42% that happens quite rapidly with seladelpar. So again, you might imagine that in order for a placebo patient to be a responder, with about a mean 4% reduction, it's very likely those responders are sitting in hovering just above 1.67, and getting, frankly, just below as opposed to getting far below that line, clearly we can see that when we look at normalization as a much tougher threshold. So I think there's a lot you can glean from the data sets we've presented previously and the consistency of these data to that and the clear benefit seladelpar is providing.
Tsan-Yu Hsieh
Got it. And as you kind of think about market expansion opportunities, obviously, IDEAL is a nice way to kind of expand that opportunity. But in terms of addressing still nonresponders, I would say, what's your view on adding a third component like a [ 5 rig ] down the road as a corporate strategy? .
Charles McWherter
Yes. Well, thank you for the question. Of course, that's still a little ways into the future for us to consider. But what you're getting at is if you have 2 agents, UDCA and then a second-line treatment and you still have a patient that doesn't respond, would you contemplate adding a third agent. That's something that's, of course, been discussed, and there's been a couple of studies now that have conducted looking at that.
For us, we think seladelpar really is perhaps the most interesting agent if we're successful and it's approved to initiate second line. And then after that, would patients be considered for yet another agent, it would really depend upon the safety of combination of that second agent. There's a benefit risk calculation to take into account. And so that's something that we'll have to be able to examine as we get into the market and after we have some broader experience with seladelpar.
Tsan-Yu Hsieh
Got it. Congratulations again.
Operator
Our next question comes from the line of Ed Arce with H.C. Wainwright.
Antonio Arce
Let me add my congratulations on positive data across the board here on the primary and secondary end points. I just wanted to ask a couple of questions just related to the range and breadth of the responses. As you mentioned earlier, the baseline ALP was rather high, closer to the Phase II study. Just wondering if there were data around those patients that had a lower ALP, say, closer to 290 and what the responses were there. And also, the -- turning to pruritus. I know that you had prepared an earlier study data around the proportion of patients that achieved a 3-point and a 4-point reduction. Wondering if that is forthcoming or that's something you can share now. And I have a follow-up.
Sujal Shah
I appreciate the questions, Ed. First, I think it's important for me to point out, you're correct. The baseline here ALP was about 314 units per liter, really mirrored what we saw in Phase II. And again, the response we see on seladelpar is, in fact, quite similar to what we saw in that Phase II study.
I think the important point here to highlight is the percent reduction, the relative reduction in ALP, we've always found to be independent of baseline ALP level. So certainly, we have patients well above 314 units per liter on treatment. We have some patients below that bar, given that that's the mean but this 42% relative reduction we see is quite consistent, independent of that baseline ALP.
With respect to your second question on RESPONSE, I think you're referring to some of the data we shared in the ENHANCE trial where, for example, we looked at response rates on patients NRS changes those with at least a 4-point or greater reduction in itch, where we saw almost 37% on 10-milligram seladelpar versus about 5.5%, seeing that dramatic drop in NRS on the placebo arm, those data would be forthcoming with respect to RESPONSE.
Antonio Arce
Great. And then in addition, I wanted to ask if you can share any -- if you will report actually any additional measures of quality of life beyond pruritus, such as fatigue and sleep? And if -- and what's your strategy in terms of inclusion in the label?
Sujal Shah
Yes. Again, I appreciate the question. And I think a few things to point out. You can take a look at our Phase II publications in which we, in fact, look at various quality of life parameters outside of pruritus, including, as you mentioned, fatigue and sleep, we do have PBC-40 as a validated measure of quality of life in patients with PBC in response study. So again, we're excited to dig deeper into that data and have opportunities to both present and publish.
What we've seen historically, again, are improving trends on symptom burden outside of even itch. And so once again, I think we'll look forward into having a chance to share more of this data, obviously, into the future.
Operator
Our next question comes from the line of Thomas Smith with Leerink Partners.
Thomas Smith
Let me add my congrats on the data. A couple, first, just on data presentation timing, late-breaking abstracts at Mission ASLD opens on September 14. Is it reasonable to expect you'll be targeting ASLD here for the potential data presentation? And then secondly, we just saw Ipsen post the details of their confirmatory study for elafibranor on [indiscernible] looks like a 450-patient placebo-controlled outcomes design. Can you comment on their approach and just provide an update on your latest thoughts and how you're thinking about your confirmatory study?
Sujal Shah
Yes. I appreciate the question. So you're correct, the ASLD is in November. Obviously, we're quite excited about opportunities to present when we have those opportunities, and you can expect us to move here quickly towards at least applying to have that opportunity in the near term.
With respect to confirmatory study, I'd rather not comment on any other sponsor. I can tell you a few things on our side. We've had discussions with regulators around an outcome study in the setting of PBC for quite a number of years, given the development program with seladelpar. At this point in time, we believe we have all the feedback we need to initiate this work. We'll share details about this study prior to regulatory filing. As you know, a study must be enrolling patients in a confirmatory trial prior to submission of regulatory approval, and we intend to move forward here in a very timely fashion so that we can file as quickly as we can as well. I can tell you, again, planning actually began prior to today's data announcement and start-up activities are, of course, ongoing. We recognize some of the challenges in outcome studies, but we're confident that we'll have an approach perhaps that's somewhat unique to what others have done here and excited to, again, do the right thing for patients, important for us to forge a path here as well as to continue to investigate real-world data and generate world evidence. That's another parallel work stream inside of CymaBay. I think we've got some of the brightest and most talented individuals here with that experience, and we're excited to move that work stream along in parallel.
Thomas Smith
Got it. That's super helpful. I appreciate the color. And congrats again on the data. .
Operator
Our next question comes from the line of Mayank Mamtani with B. Riley Securities.
Mayank Mamtani
Congrats on the very, very strong results there. Sujal, just to clarify on what you said on pruritus responder rate analysis. Have you conducted that statistical analysis on the 2- or 3-year 4-point cut-off rate and also, have you looked at the pruritus AE rate as part of the safety evaluation and see if there's any numerical difference? And then I have a quick follow-up for Dr. Hirschfield.
Sujal Shah
Yes. I appreciate the questions, Mayank. So again, I think as you can appreciate, we do want to preserve our ability to have a presentation at upcoming medical meeting. It's important for us to share this level of data today. That's our commitment to patients. Patients have really devoted themselves to the work that we're doing and to limit the amount of data we share here today would be a disservice to those patients. And so we've done our best here to share as much as we can. But of course, responder analysis on itch would be things that would be forthcoming that we would want to preserve for an opportunity to have an appropriate presentation at an upcoming medical meeting.
With respect to pruritus AEs, again, I think that will be additional data that we will look forward to sharing. Often, it's not atypical to see really more of a brief safety summary at top line results. When we do share the overall safety summaries, again, at an upcoming medical meeting as well as in publications, you'll see a much more fulsome set. And I think the data that we've generated in the past is a very good guide. Again, on all parameters, we really see a lot of consistency here. And as we mentioned, with respect to safety and tolerability, consistency with what we've observed in the past, the key here, we think is seladelpar is really demonstrating an ability to reduce itch in patients with PBC again, somewhat groundbreaking in PDC from our perspective. And so we're excited about that as well.
Mayank Mamtani
Got it. And then Dr. Hirschfield, your comment on the treatment goal evolution in guidelines. Obviously, that's happening pretty rapidly. So just curious, some of the responder rig definitions, is your understanding that seladelpar could really stand out given the breadth of biochemistries and the depth that you get. Obviously, you haven't seen the [ ALP ] data, but in the past, that's been really good. Or you sense having a multi-mechanism approach where you could really have that very good opportunity initially to knock down these never biochemistries and have a really good chance early in the patient journey to have that long-term liver health impact?
Gideon Hirschfield
I mean I think what you're asking me is over time, as we become more proactive in our treatment, the early adoption of second-line treatment would be predicted to have even better responses than waiting to fail and the patient having the disease duration extended before you add second-line treatments.
And so I would agree with your sentiment that there is a high likelihood that you can see even better results over time as we adopt new treatments earlier, and really get on top of the disease at the very beginning rather than waiting for persistence ductopenia and duct loss and then a reduction in the chance of responding. And therefore, in that context, the data that's being presented today is very good news for patients to see already very consistent effects consistent with prior studies and consistent with our goals of treatment efficacy and symptom relief.
Mayank Mamtani
Very helpful. Thanks again for taking our questions and congrats to you.
Operator
Our next question comes from the line of Shawn Kim with Jones Trading.
Unknown Analyst
Congratulations. Just a quick one. Can you comment on the commercial readiness activities that you have ongoing? And also maybe any potential further ramp-up that you're anticipating now that you have the positive Phase III data?
Sujal Shah
Sean, I apologize. Can you repeat your first question?
Unknown Analyst
Yes. Just curious, the commercial readiness activities that you have ongoing for seladelpar and any further ramp-up?
Sujal Shah
Yes, I appreciate that. So yes, good question. Again, as I commented perhaps briefly, really pleased with the team that's been coming together, highly experienced individuals when we look across our franchise lead, Head of Marketing, we're starting to really build out a team in analytics, as well as market access and thinking about commercial operations, that is continuing to expand, really, just a stellar organization, given the fact that we think there's significant upside in terms of the number of patients that might benefit from seladelpar and our confidence that we can actually deliver all the way through that goal of actually commercializing.
You should expect to see us continue to, in a very smart and efficient way, invest in our team and those activities. A lot of activities, in fact, initiated already around medical affairs. Again, a group with just absolutely tremendous experience, relationships in this industry and in this therapeutic area. I couldn't be more pleased again with the entirety of that team that on today's announcement is already hitting the ground running with sharing these data, not just with the PIs obviously, involved in our studies, but with hepatologists and GIs broadly to provide some appreciation for this early data set and continued data that we'll look forward to sharing.
Operator
Our next question is a follow-up from the line of Yasmeen Rahimi with Piper Sandler.
Yasmeen Rahimi
Thank you team for allowing me to ask a follow-up. Have you had a chance to look at the fatigue benefit? And maybe just comment on whether you observed any directional or statistical separation in fatigue? And then the second 1 is, is there a chance that once seladelpar gets launched that given its use that you could handicap and maybe prevent other second-line agents to restricted use. So I would love to hear some color around how the market entrance of seladelpar could shape the current landscape of therapies in development?
Sujal Shah
I appreciate the questions, Yas. Again, unfortunately, limited information I can share with you here. Of course, fatigue is captured and represented in the PBC-40 questionnaire that is part of response. Again, some of our historical data, I think, was promising with respect to potential improvements in fatigue, but it was very early, and I'd point out it didn't include a placebo comparator. Here, again, we'll look forward to digging in more into that specific element of seladelpar's profile with respect to the response data and are excited to dive deeper into that.
With respect to the dynamics in the market, again, I think a bit premature for us to describe how the entirety of the landscape will change. I think these data, we think, are seminal because they do represent the potential for perhaps a best-in-class second-line treatment alternative. And for those patients that are inadequate responders to UDCA effectively even for a broader patient population that never normalize on UDCA with respect to biochemistries, patients that continue to be plagued with symptom burden we think these data have the potential to be quite seminal in being an alternative for many patients that may benefit. So we're going to turn our attention to that next phase here with respect to both regulatory discussions and filing, and really setting ourselves up for a potential successful commercial launch, again, if we're successful at that first part.
Operator
Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Shah for any final comments.
Sujal Shah
Well, seladelpar has already been quite a journey in its development for patients with PBC. And I'll say that while days like today can often be a time of reflection, I can tell you that it is equally a time of focus for us here. I couldn't be more thrilled with the people we have here at CymaBay, who will now dive deeper into these exciting data as we look forward to presenting as well as filing for regulatory approval, all the work our teams will do in CNC medical affairs, pre-commercialization, we've just got a stellar team here at CymaBay to really put behind this effort to bring seladelpar potentially to every single patient that may benefit. We look forward to talking to you all again soon. Thank you again for joining us for what we believe is really a milestone date for all patients with CymaBay. .
Operator
Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation
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