Incyte Corp to Discuss the Key Data Presentations at AAD Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : A few on povorcitinib and then a couple on Opzelura, please? First, for Dr. Kwatra on povorcitinib. How do you think about the safety profile here, specifically the serious treatment-emergent adverse events and the grade 3 plus treatment-emergent AEs? What were those? And I guess, overall, is the safety profile acceptable to you? And then while we're on povorcitinib, I think you mentioned that elevated blood eonosinophils predict response to dupi. Is that the case for other therapies too or thought to be the case? And with that in mind, I noticed that baseline demographics weren't broken out by treatment arm. Were the racial demographics balanced in this trial? And what about the other baseline demographics?

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : Yes. It was on the elevated eosinophils, predicting response to dupi and whether we think that's the case for other therapies, given that I think you said that those are elevated more so in Caucasian and Asian patients. And so with that in mind, were the racial demographics balanced in the povorcitinib trial? And what about the other baseline demographics? Because it looks like the data is provided on a pooled basis. Shawn Kwatra Yes, that's a great question. So the -- all clinical trials right now have more Caucasian patients and less skin-of-color patients. So that's not unique to this trial, that's every trial. The HS trial had very high numbers of African-Americans actually higher than the population prevalence. So we're. Martina Porter We're going crazy trying to get... Shawn Kwatra Yes. But there was no imbalances, but that's consistent with the dupilumab and nemo arms. For the elevated eosinophils, I mean, we just found it and this group in China just found it. So now we're trying to look at it. We have no idea with nemolizumab. But I will say, if you look at some of the AEs, you have -- you can see how the cookie is crumbling. So nemo, you have some AEs for eczematous events, either eczematous or eczema, it's a small percentage, it's managed by. But for dupi and (inaudible) too, what we're seeing is there's an immune switching phenomena where then you're getting -- I have a few patients who have a [story as a forum] phenomena. We know about head and face neck dermatitis in our lab studying this. So what we think is IL-4 receptor alpha actually upregulates Th117 responses, which may actually harden some of those different pathways in PN patients. And then with nemo there may be very mild, but there may be some effect in subsets of patients with the eczematous derm as well. So we have some kind of insights into it. I would expect that you have very good efficacy in both groups with this molecule because we know it's IL-22 interferon gamma IL-6, and JAK1 hits all those. So that would be my hypothesis, but we'll look at it in the translational data.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : And can I ask a couple on Opzelura? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 11, 2024 / 4:00PM, INCY.OQ - Incyte Corp to Discuss the Key Data Presentations at AAD

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : On the explanation of the different rates of dropout in the Opzelura arm not being explained by those with more nodules at baseline, is that to say that there were disproportionately high dropouts from the Opzelura arm versus placebo in the milder patients? And then what might explain that? And then secondly, for Opzelura and HS, it looks like the HiSCR didn't separate until week 16, and I'm curious about the time course of the AN50, 75, 90, et cetera, response criteria. Did those also not separate until week 16? Martina Porter Well, sort of a heads like you were saying, we haven't cut all the data that way yet to -- so I don't know the answer about the separation for the AN50, 75, 90 by week. I can tell you for the dropout, let me just see, wait a sec here. Oh, there it is. Thanks. Yes. So the dropout was the same between the vehicle and the rux cream for the moderate patients, which we define in the 5 to 10 arm, and the delta there was different and it had a very similar pattern that we saw at week 8 where they were separating. The milder patients is where all of the dropout essentially occurred almost. And of those patients, some of them -- well, there was a big portion of them, 5 that were lost to follow-up, and all 5 of those patients were of the same racial demographic. And it wasn't clear why those patients dropped out. And it could be that they were not experiencing much improvement because they started out with only 3 or 4 lesions and their expectation was to be clear. And so I think it's a little bit difficult to really tease out with such a small dataset if these trends will carry forward to a larger trial. But also, I would say the other thing is, in this study, if you started as mild and you're only treating one area where you had those lesions and something pops up elsewhere, then you're artificially also seeing fewer changes because there's no way or, in my opinion, no expectation that treating an area at a distant site would have prevented those lesions from popping up elsewhere.