Jay Luly: Okay. And the second part, I guess, is relates to oral remdesivir for COVID. I mean, I guess our initial reaction, I mean, we, like everybody else, just got that news late yesterday afternoon. I think it simplifies the COVID landscape, which is – one of the things that I think everybody who’s involved in COVID, including us, everybody who’s interested in COVID, whether its strategics or the government. We’re trying to figure out what the competitive landscape is, or what the arsenal of drugs is going to be available for COVID patients. And it seems like there’s one fewer now. So that’s going to help clarify things. I guess, Chianogi is another one that’s due to turn over a card pretty soon here. I guess there’s a question about what’s Pfizer doing with their follow-on molecule.
We haven’t seen that they’ve advanced it, but so a question mark there that will hopefully get sorted here in the nearer term. And then, we’ll have a more complete view of what that competitive landscape looks like, which is, again, important for anybody who would be making funding decisions going forward. Our plan, as we’ve stated a few times before, is to only pursue 235 in the context of a collaboration.
Amy Li: Okay. Understood. Thank you so much. That was very helpful.
Jay Luly: You’re welcome.
Operator: And thank you. And one moment for our next question. And our next question comes from Eric Joseph from JPMorgan. Your line is now open.
Eric Joseph: Oh, thanks. Just a quick…
Operator: Eric, I’m sorry. You’re sounding a little low there.
Eric Joseph: I’m sorry. Can you hear me now?
Operator: Yes, sir.
Eric Joseph: Yes. Okay. Thanks for taking the question. Just your 3Q guidance for reading out RSVPEDs, does that anticipate full accrual of your target of 90 patients? If you sort of end up tracking under that goal after this season, do you go ahead with a readout, or do you perhaps sort of push out timelines a bit?
Jay Luly: No, I think we’re still targeting to, at least hit the target enrollment, that’s the plan, that’s plan A. And to report data on the full set in Q3.
Eric Joseph: Okay. Great. And sorry if I missed it earlier, but can you just comment a little bit on just how accrual is taking place with RSV high risk and sort of how much further behind it might be, from a full accrual, or how much further behind basically a readout from that study is tracking relative to RSVPEDs? Thank you.
Jay Luly: Yes, so, quarter-after-quarter, I’ve been asked, which study do you think is going to read out? And I could never answer the question because, especially when we target as a goal of Q3 for data. But as I said, I think at the JPMorgan conference, as we get a little further into this season, we’ll have a better sense of it and should be able to make a call. And clearly today we’re making that call. It looks like PEDs, is the one that will. In terms of the HR, how far behind is it? I think we just got to continue the recruitment in that. Obviously, I think we’re going to need to go to the Southern Hemisphere, continue on beyond the Northern Hemisphere season. And we’ll just give updates as we go. Once we have a good, more, crisp target guidance to provide it, we will.
But we did see it. And to remind you – since it’s a larger study than PEDs, right? So it’s roughly twice the size. And it started later than PEDs. But we did see a nice uptick in this Northern Hemisphere season. It was really gratifying to see that. So, we’ve got over 100 sites now. We’re in over 15 countries. Yes, we got a pretty big catcher’s mitt on now. And – it’s just all about execution and hoping, the trends towards normalcy continue. But that’s been again, something that we’ve seen this COVID season in terms of when it started and the shape of the season and everything else. This is the first season we’ve seen like this in years.
Eric Joseph: Okay. Great. That’s helpful. Maybe one follow-up, if I could. If you have a clear, what seems to be clear evidence of, reducing viral load in RSVPEDs? Can you talk a little bit about gating steps running an efficacy study in the pediatric population? Is that dependent on results from RSV high risk? Thank you.
Jay Luly: No, I mean there, I can let Scott comment on that. But they’re isn’t, they’re just very different patient populations. Scott, I don’t know.
Scott Rottinghaus: Sorry, Scott Rottinghaus, it’s different patient populations. And we’d feel comfortable moving forward in pediatrics with positive results from our pediatrics study.
Eric Joseph: Okay. Great. Thanks for taking the questions.
Jay Luly: You’re welcome.
Operator: And thank you. And one moment for our next question. And our next question is Jay Olson from OPCO. Your line is now open.
Unidentified Analyst: Hi, this is John [indiscernible] for Jay. Thanks for taking the question. I’m glad some progress. Maybe two questions for us. First on the RSV program. Just for zelicapavir, if you decide to move the program into a pivotal study, just wondering how are you thinking about the adoption of RSV vaccine in your target patient population? And would you maybe exclude patients who recently took the vaccine? Were there some other thoughts around that for the moment? And I have another question for the CSU program?
Jay Luly: Hi, Scott, you want to take the RSV?
Scott Rottinghaus: Yes, for sure. So from a vaccine perspective, obviously the coverage of vaccines is going to be far from 100%. And they’re not 100% efficacious. So, we still see the market and the clinical opportunity persisting there. So that’s the first important point. And then in terms of a putative Phase 3 study in pediatrics, we envision including patients broadly, including patients who break through on vaccine or [indiscernible]. So we again, envision broadly studying patients in pediatrics.
Unidentified Analyst: You had it. That’s helpful. And for the CSU program, I’m just wondering your thoughts on how would you position the oral KIT inhibitor into the treatment landscape for CSU? And there’s like recent BDK inhibitor that are positively. So just wondering if you think that’s kind of a good benchmark, for efficacy you’re shooting for? Thanks.
Tara Kieffer: Hi, this is Tara. Yes, thanks for the question. I guess the way we look at the CSU landscape is broadly at all the different mechanisms. If you think about the standard of care, being antihistamines and only 50% of the patients really being controlled on that, very few of those go on to get the only indicated biologic, which is [Xolair]. The data coming through from the BDK inhibitors, which are an oral option in development. Those studies did read out positive. I would kind of put their efficacy to be somewhat similar to Xolair in that camp. What we’re excited about from a KIT inhibitor perspective, is the data that was generated through an antibody program in Phase 2 where they have seen some of the best efficacy in this disease so far.
And that’s really the benchmark we’re looking towards and hoping to replicate that data with an oral option. So that’s sort of how we’re seeing this evolve. Obviously, we’ll continue to watch as the data comes out, hoping to provide additional efficacy over and above what a BDK inhibitor might provide.
Unidentified Analyst: Yes, that’s maybe a quick follow-up on the last part. I think there are some like side effects for antibody approach, maybe including the hair color change or some change in blood cells. So do you think the oral KIT inhibitor, may have some advantage on safety as well? Thanks.
Tara Kieffer: Yes, so there are certainly known side effects, on-target side effects for KIT inhibitors. Overall, the antibody has had a good safety profile. Most of the AEs were mild or moderate, and they resolved. The ones that are known on target that you mentioned in terms of your neutropenia, there were generally mild hematologic impacts, and the neutropenia sort of stabilized after a short time period of a week or two of dosing. And so, what we did find out is that it didn’t get worse with longer dosing, and so it seems quite manageable, at least at the levels that they’re observing so far in the clinic. They were not associated with infections, at least in the trials thus far, though. And so, we’re obviously keeping an eye on it, but we don’t think that will be a limitation.
Unidentified Analyst: Okay. Got it. Thank you so much.
Operator: And thank you. And one moment for our next question. And our next question comes from Brian Skorney from Baird. Your line is now open.
