Unidentified Analyst: Okay. Appreciate that. And then one quick follow-up. What do you think we should focus on when your full safety adverse event table info is disclosed since that wasn’t really part of the top line release? Should you be needing to show improvement on pruritus? I’m sure this is a differentiating attribute that is also included or will be included on the label? Just any extra color.
Sujal Shah: Yes. I think the statements we made at top line were that the safety we observed in response in the treatment arm with seladelpar 10 milligrams was comparable to what was observed in placebo. We also made a statement that the safety was in fact consistent with what we’ve seen in previous studies. I think for seladelpar that’s a fairly significant data set the Phase 2 north of 100 patients out to a year 50 plus of which went out to two years and then the ENHANCE study that it actually randomized 265 patients, all of which are in the published domain. And so I think there’s a very rich safety data set to interrogate in the published domain for seladelpar already. And so what we’d observed in response is very consistent with the safety profile that we’ve now published on in multiple studies.
And so I think that should garner some level of confidence and we’ll look towards next week again to share more of that data out of response. You asked specifically about AEs with respect to pruritus. Again remember, perhaps up to 70% of patients with PBC can experience pruritus in the course of their disease. So not uncommon in the setting of clinical studies to observe AEs of pruritus. The more important tool to assess whether or not you actually have an impact on reducing itch of course are the NRS tool that we’ve incorporated in response as well as our prior ENHANCE study other PROs including 5D itch as well as PBC-40 pruritis domains. I think interrogating these tools really gives you the best sense of whether or not you have an impact on reducing itch.
So I think all of these collectively are insightful and we look forward to sharing more of this data next week.
Unidentified Analyst: Awesome. Appreciate that. Congratulations again. Thank you taking my question.
Sujal Shah: Yes.
Operator: Our next question comes from Thomas Smith with Leerink Partners. Please go ahead.
Thomas Smith: Hey, guys. Good afternoon. Thanks for taking our questions. Just wanted to clarify now that you have the revised breakthrough therapy designation in the US their plans to engage the EMA and a similar conversation around the scope of the prime designation. And is that something you think could be valuable to either your regulatory path in Europe or perhaps securing more favorable reimbursement or access there?
Sujal Shah: Chuck, would you like to make some opening comments?
Charles McWherter: Yes. So thank you, Thomas. A very logical question. I think our focus now is on submitting our application and then having the kinds of presubmission meetings that you have rather than opening up once again at the regulatory path for Prime. Prime is — seladelpar’s position with respect to Prime is very unique. Most of the prime-designated products in Europe are — in the EU are actually oncology products or other more — not more but different types of serious diseases. So we think with the benefits that come to us from the prime designation it provides us with close access and interactions with rapporteur, we’re able to have a frequency and a quality of regulatory interactions. So I think I would not be guiding you towards thinking that we’re going to just repeat the same process that we did in the US even though I think it’s logical that people kind of think that breakthrough designation and prime are the same thing.
They do have some semblance but they’re not exactly the same thing. So we think the most important thing for us to do is share the data sets to move forward towards submission and get into regulatory review as soon as we can. As Sujal mentioned earlier I think it’s the — one of the strengths of our program is that we’ve had more than 500 patients with PBC dosed with seladelpar. We have more than 300 ongoing as we speak. Now the size of the data sets and the consistency around the features that came with the revision namely pruritus and two placebo-controlled studies also pruritus effects in the open-label study and then the totality of patients that we’ve treated that have cirrhosis is something that is it’s an opportunity. We have more than just response.
We’ve got the other studies to supplement those experiences in the subpopulations.
Thomas Smith: Got it. That’s helpful. And if I could just sneak in a quick follow-up here. I know you collected some paired liver biopsy data in the response study based on guidance from the FDA. I was just wondering if there’s any requirement or if you were conducting any optional collection of paired liver biopsies in the AFFIRM trial with the compensated cirrhotic patient population.
Sujal Shah: Chuck?
Chuck McWherter: Yes. So we’ve collected we just once we started response we for most studies not all of them we’ve continued on that commitment we think to be able to characterize histology with disease status is a unique and differentiating feature of the seladelpar program. So we’ve actually collect paired liver biopsies in ASSURE. And we will be collecting biopsies also in AFFIRM. Now they’re optional. So it’s not a requirement because it’s not part of standard care in PBC. But for those patients, who are interested and willing to understand the status of their histology for their liver, and to help us gain an understanding of what might happen in treatment responses, we think that’s an important effort to be making.
Q – Thomas Smith: Got it. That makes sense. Okay. Thank for taking the questions. Looking forward to [indiscernible]
Chuck McWherter: Thank you, Thomas.
Operator: There are no further questions at this time. So that concludes our Q&A session. I would like to turn the floor back over to the company management for closing comments.
Sujal Shah: Thank you, operator. As we’ve discussed to date, with positive pivotal Phase 3 data now in hand our team is accelerating each of the activities necessary to get seladelpar to patients as quickly as possible. Just a few weeks ago, we were fortunate to have several people living with PBC share their stories with all of us here at the company. They remind us of the need they and others have for us to advance the potential treatment alternative that has the potential to treat earlier, to treat to normalization, and to treat to reduce symptoms and improve quality of life. Their daily struggle continues to inspire us to be focused, to be driven and sincere in the work that we do here every day. We could not be more excited as we’ve mentioned again today, about the liver meeting in Boston starting later this week.
Again as Chuck mentioned, in his remarks fortunate to have Dr. Gideon Hirschfield, on behalf of all of the study investigators present a more detailed summary of the RESPONSE Phase 3 results in a late-breaker presentation on Monday, November 13. This will be our most significant presence at the liver meeting, since we began development of seladelpar in PBC in 2015. And we expect CymaBay and seladelpar to be featured prominently at the Congress, as we meet with health care professionals as well as patient advocates many of which have been our valued partners for many years. And again, as we discussed in today’s Q&A session, our commitment to people with PBC continues beyond RESPONSE with our ongoing studies ASSURE, IDEAL and AFFIRM and we expect to share much more of our progress with you in the months and years ahead.
Thank you, again for joining.
Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
