Jay Luly: Yes. Again, so there are two parts to the study. Part 1 is completed in all age cohorts. Part 2 of this study is done in the older age cohorts. We’re down to the final cohort of 20 patients. It’s the youngest children from age, 28 days to six months and we’ve been actively recruiting that cohort. So, we’re in the home stretch and we just — unfortunately, our pool of patients is now only one-sixth of what it was based on age groups. So, it’s a narrower pool, and any older children, we really have to — we can’t enroll in the study anymore. We’re just really zeroed in and focused on getting the remaining young children to fill out this cohort.
Nik Gasic: Got it. Thanks, Jay. Maybe on CSU, curious, what are you hoping to see in a future Phase 1 for your oral inhibitor in terms of safety? Maybe how should we think about frequency administration for this asset? Is it once daily, twice daily, how should we think about that?
Jay Luly: We are still finalizing the candidate. Again, we are targeting to have the finalists in Q4. But suffice it to say, we are very much zeroed in on QD dosing. We’ve made molecules that are very potent, that are very selective. We’re optimizing DMPK profiles, tissue distribution, a number of other sorts of parameters like that to make it the kind of candidate that we typically bring forward. So, we’ve already shown data on a strong prototype and we continue to — the chemists are very busy, well not just chemists, but the chemists and all the biology people who are doing the characterization, and our DMPK and safety team are working very, very diligently on this. So, we would be aiming for a QD candidate that would have the best safety profile we can provide as well as good potency and selectivity.
Operator: [Operator Instructions]. Our next question comes from Brian Skorney from Baird. Your line is now open.
Unidentified Analyst: Hi. This is Luke on for Brian. For EDP-323, can you remind us of your current thoughts on potentially entering a Phase 2b in otherwise healthy adults, as opposed to starting with the high risk in pediatric populations, like you’ve done with zelicapavir? And would you wait for RSVPED or RSVHR data to make this decision?
Jay Luly: Yes. That’s a good question. I mean the short answer is, we won’t do another RSV study in otherwise healthy adults. We found out from our RSVP trial that otherwise healthy folks just self-resolve the infection so quickly on their own. So, they’re really not in need of a therapy. We would only focus on high-risk patient populations and we are hoping to have an abundance of data here in the second half. We’ll have 323 data, we’ll have PEDs data. We’ll be able to look at the totality of the information and figure out how best to position 323. So, for us, it’s been about bringing another strong mechanism forward. We’ve been working on this from the beginning. I guess, we’ve been working on it for a few years now to bring forward another differentiated asset in RSV and that could give us the potential for doing combination therapy down the road in particularly hard-to-treat patient populations.
Potentially, it could help widen the treatment window, where we to go after a patient with two drugs rather than one. So, it’s just part of our strategy overall to try to build a leadership position in RSV as a therapeutics company and the more sort of cards we have to play, I think we can come up with ways to leverage another asset over time. So the key is getting it up to a strong threshold on the challenge study data, first.
Operator: And our next question comes from Liisa Bayko from EVR. Your line is now open.
Unidentified Analyst: Hi. This is Zima on for Lisa. I have a question on the 323 program. What doses of 323 are testing in Phase 2a human challenge study?
Jay Luly: Yes. We are looking at a couple of different dose regimens. So, the first is 600 milligrams straight across for five days. The other is 600 milligram loading dose on day 1, followed by 200 milligrams on each subsequent day. It’s kind of like, in antibiotics, they do that sometimes. They give you a loading dose on day 1 and then a lower maintenance dose for a few days thereafter. So, we just put both of them in and I think, in theory, either at least based on calculations and modeling either has a good chance of demonstrating the activity we want. One obviously is a lower dose and has different cost of goods ramifications et cetera, et cetera. We’re just — the challenge study is just such a wonderful way to tease all those kinds of questions out because you don’t have to wait for the season. You can just infect human volunteers, line cohorts up every few weeks and dose them. Does that answer your question?
Unidentified Analyst: Yes. That’s helpful. Thank you. I have second question on the patent against Pfizer because last year, Pfizer said that PAXLOVID doesn’t infringe the patent because PAXLOVID has chi-floral group, which is not described in your patent. If you can comment on that?
Jay Luly: Yeah, I really can’t get into the discussion on our ongoing patent litigation. The only thing I can say is that assuming that were to go to trial, we would expect a trial around the end of the year.
Operator: [Operator Instructions]. Our next question comes from Jay Olson from Oppenheimer. Your line is now open.
Jay Olson: Hi, Jay. Thanks for providing the update and taking the questions. On the immunology program, what are the most important differentiators you are looking for with your oral KIT inhibitor candidate versus other oral KIT inhibitors in development? And how are you thinking about positioning oral KIT inhibitors versus other oral therapies for CSU, such as BTK inhibitors?
Jay Luly: Thanks for the question, Jay. I’ll let Tara speak to that.
Tara Kieffer: Sure. Hi, Jay. So, I think some of the data that’s been generated from the monoclonal antibodies against KIT, that would be from Celldex, and then an earlier program with Jasper had indicated that inhibiting this target has some of the best-in-disease efficacy, at least from the Phase 2 trials that have been have been run. It gives us confidence in the target and what we’re really hoping for our program is to match or even exceed potentially that efficacy with a good safety profile, just with an oral route of administration. So, that’s the goal of our program. As you mentioned, there’s other companies working on this as well. They’re all early. They’re all preclinical at the moment. There’s really only preclinical data, at the moment.
