Operator: Thank you. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is now open
Jay Olson: Congrats on the progress. I’m curious about the fresh trial for INT-787. It says on clinicaltrials.gov that patients must participate in alcohol use disorder program. So will patients be allowed to consume alcohol during the study? And if so, how do you plan to manage alcohol consumption and the potential impact that could have on the trial outcomes?
Jerry Durso: Michelle?
Dr. Michelle Berrey: Yes. It’s a great question. As we were designing this study, we worked with many of the centers across the U.S., U.K. and France really experts in this area. And what we have found is that it’s really critical for outcomes for these patients to commit to being an outpatient program immediately after their release from the hospital. So the trial is focused on hospitalized patients, of course, but then they would continue for their follow-up in this outpatient program. We do find that patients in general don’t consume alcohol within the first couple of months after release from the hospital, it’s I think special period in that recovery, certainly after that, we do see recidivism, but we are working, again, closely with these centers who have expertise in treating these patients and in maximizing the — their retention in the trial and making sure that these have lost to follow up patients because of recidivism early.
Operator: Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.
Unidentified Analyst: This is for Salveen. You referred to this briefly in the past. So how are you thinking about the product market fit for OCA given the data demonstrating greater efficacy in three patients compared to F2 patients in NASH as well as given the data from emerging treatments like the ones from .
Jerry Durso: Yes. So, I can start on this and just make sure I got the question correctly. I understand the question kind of positioning given our stronger efficacy in F3s in the context of other data being out there. I mean, I think, look, we continue to do all the deep work in market and continue to confirm the understanding that this incremental efficacy that we see in the advanced population is an important part of the overall value proposition. We also know that look there are different mechanisms of action at play here between OCA where you have clearly consistent antifibrotic effect and other drugs that might be working differently. So again, I think everything we learn in an updated context, including consideration of other potential profiles that are out there confirm that the unmet need is high overall.
The unmet need is most pronounced in these more advanced populations and that the well-known profile of OCA plays to that more advanced population. Of course, there is an asymmetry of information available. So we know a lot about OCA in the context of all the safety and efficacy we’ve put out. The profile of other emerging therapies, as you would expect, are there’s less information, particularly when we consider the longer-term experience that we now have with OCA. And importantly, when we think about the improved the benefit-risk profile of OCA that we believe we have from the first submission. One of the important dimensions is that longer-term safety experience where we believe we have the opportunity both in the regulatory dialogue and ultimately, hopefully, in market to talk about appropriate chronic therapy, the right guidance around what to measure and monitor over time.
