Scott Rottinghaus: Yeah, sure, thanks, Jay. We’ve enrolled patients in both Northern and Southern Hemispheres in both the pediatric and the high-risk studies, including in the current season ongoing in the South. I don’t have the exact numbers in front of me either, but we are continuing to enroll actively in both of those studies. As Jay mentioned on the call in the pediatric study, in particular, we are down to the last cohort and enrolling in the South.
Jay Luly: Yes. I think directionally maybe the northern hemisphere beyond question is more highly represented in terms of clinical trial sites than the southern hemisphere. I mean, we’re in many different European countries, many different North American countries, we’re in Asia. In the Southern Hemisphere, we’re in South Africa, we’re in Brazil, we’re in Argentina, New Zealand, Australia, not as a larger footprint in the Southern Hemisphere, but nonetheless, we’re hoping to make good progress on enrollment and wrap this up as soon as possible.
Unidentified Analyst : Understood. And then just follow up on that. Can you please remind us how much overlap are there between the Southeastern Hemisphere RSV season and flu season? And also, do you expect to that point for the HR study, do you expect the study to complete enrollment in line with the conclusion of the Southeastern hemisphere RSV season?
Jay Luly: Was the first question about overlap with the flu season?
Unidentified Analyst: Yes. How much overlap are there between the RSV season and the flu season?
Jay Luly: I mean, generally, they’re somewhat correlated, but even in any given year, they can deviate a little bit one way or the other. Flu could come on a little earlier or a little later, come on twice. RSV has been and flu, but especially RSV have been substantially impacted by the pandemic years in terms of just only more recently starting to settle down into what we would call more normal seasonality. I think, again we follow, we track RSV season much more closely than flu. As it relates to HR, my guess is, we’ll need to come back to the Northern Hemisphere, given that we again have just much stronger footprint there. We made excellent strides in the Northern Hemisphere this year. That’s why especially a very nice season for us.
So, we may need some of that as well. Again, we’ll be tracking this and reporting progress later this summer, when we’re well into the Southern Hemisphere season and we’ll be able to forecast a little bit better, based on more current data, but that’s my expectation.
Unidentified Analyst : Okay. Understood. Thank you again for taking my questions, and we look forward to the progress in the second half of this year.
Operator: Our next question comes from Roy Buchanan from Citizens JMP. Your line is now open.
Roy Buchanan: Thanks for taking my question. Just a couple on RSV. Jay, for the RSVHR, I think I heard you say that, it was powered for a 50% reduction in symptoms and it’s probably a high bar. Just wondering where that conclusion about it being a high bar comes from. I think the challenge trial you had a 75% reduction in symptoms. Are you just interpolating between that and RSVP or is there something you’re seeing in the trial?
Jay Luly: Yes. So, to be clear, we’re talking about time to resolution of symptoms. So, it’s different than in the challenge. We are looking at the number of days, improvement and time to resolution of symptoms versus placebo. I can give a little color on that. I think for example with flu and a placebo study and Tara can correct me if I’m wrong. There’s about a four-day time period for time to resolution and TAMIFLU will shorten that by a day. It’s a three-day time resolution. So, it’s a one-day shortening out of four days. That’s a 25% improvement in time to resolution. And so, the way this was powered with HR and in order to keep it a relatively small study of only just under 200 patients, it was powered on a 50% effect. Had we powered it on a 25% effect that the study would be even much larger.
It’s that fine balance of running a Phase 2 study that is enabling of a pivotal trial, keeping it at a manageable size and we felt with a couple of hundred patients, even though it’s a high bar to reach stat segment on the way it was powered, we should be able to make good decisions based on clinical — clinically meaningful improvements. Again, shortening time to resolution of symptoms by one or more days would be clinically meaningful.
Roy Buchanan: And then for the 323 challenge, what are you hoping to see there? We’ve said many times that zelicapavir data is probably best-in-class. Are you expecting to see something similar? Do you need to see something similar? Just help us think about that. Thanks.
Jay Luly: Yeah. Zelicapavir sets a high bar. The mechanism is an in-protein inhibitor. It is about the best challenge study data in any book companies ever put on the boards. So, it does represent a high bar. That said, 323 is another mechanism, it’s a polymerase inhibitor. It’s a picomolar polymerase inhibitor, so it’s super potent. Can we replicate the same best-in-class data that we saw with zelicapavir? We’ll see. Hopefully, yes. It’s hard to do much better. I think we want to be in the same range to declare it as a strong player in the field but based on every bit of data that we have pre-clinically and our Phase I data, which showed good safety, tolerability, wonderful exposures after QD dosing, and again very, very strong virology. We’ve set it up about as best as we can. We are running it at the same clinical site as we ran the zelicapavir trial. So, we’ll see. So, we should have data for that in Q3 next quarter.
Operator: One moment for our next question. Our next question comes from Roanna Ruiz from Leerink Partners. Your line is now open.
Nik Gasic: Hi, this is Nik Gasic for Roanna. Thanks for taking our questions. Maybe first on RSVPEDs, could you give us a sense of how close you are to completing enrollment at a younger age cohort of RSVPEDs? Maybe how long do you think it could take to analyze and ultimately share the data afterwards?
