Mayank Mamtani: Okay, got it. Thanks team for taking our questions and look forward to the data shortly here from the challenge study.
Andrei Floroiu: Thank you, Mayank.
Operator: [Operator Instructions]. Our next question comes from Roger Song with Jefferies. Please proceed with your question.
Unidentified Analyst: Good afternoon. This is Liam Chong [ph] on for Roger Song. Thank you for taking our questions. Our first question is about the upcoming Phase 2 challenge data. So could you give us some color on what would be the go, no go decisions for the Phase 2 challenge data?
James Cummings: I can give you some color as opposed to go, no go. I think we’d have to talk as a team. But certainly we’re looking at several endpoints and indicators, so looking at a decrease in severity of acute gastroenteritis. I mentioned before that a challenge study is very aggressive compared to what someone sees in nature. So we’re trying to ensure that those who could get sick would get sick, right? But we’re looking for a decrease in severity of acute gastroenteritis secondary to norovirus, potentially a decrease in shedding. And I think that shedding is important because that could then be somewhat of a surrogate for decreasing shedding, decreased transmission, or even may affect on infectivity I think is going to be very important.
And again, I tie that to viral shedding. And then disease severity, right? So how ill are people actually getting? I think we’re looking at all of those items along with the immunogenicity and the safety, but also trying to tease out, if we can, what a correlative immunity might look like. And I think those are the things that we’re considering as we look at that dataset.
Unidentified Analyst: Sure. Thank you. This is very helpful. So in terms for the larger Phase 2 study, do we have any guidance? And could you provide some color on the study design?
James Cummings: Sure. So I can give you some thoughts. We would look at the evidence we see of the data that we are seeing from both the 202 study that we’re talking about, that data — some of that data in hand now, but waiting on the mucosal data, as well as the impact of the data we see from the 201 challenge study. And taking a look at both of those I think we’ll be able to determine or help determine what size of a study might look like. One of those factors that may impact it is if we’re able to determine a correlative, right, having a correlative in hand would mean decreasing the size of, if not the Phase 2, certainly the Phase 3. So Phase 2b study would be larger. You’d have enough people enrolled to ensure that you have a safety set that would be acceptable to the FDA.
I don’t necessarily want to speak for the FDA, but certainly it would be larger than the study we had done now. And we would be ready to execute once we have those data in hand and have met internally. Hope that answers your question.
Unidentified Analyst: Got it, great. Thank you. Maybe a quick one for last. So in terms for the pivotal Phase 3, I know that probably you don’t have much information. So what age populations would be prioritized, if you can comment on that?
James Cummings: Sure. I’ll speak specifically to that question or generally about the Phase 3, right? Again, that Phase 3 would depend on the results of the 201 challenge study. The Phase 2 is about 2b study at the end of Phase 2 meeting with the FDA. We take the guidance of the agency literally to harness. We’re all I think interested in providing a solution for what is now unanswered, which is there’s no approved vaccine for norovirus, right? I think that we’d address the timing for the Phase 3 once we have more visibility informed by those milestones. In terms of where we’re at right now, we have tested in this study the vaccine 18 and older and I think that’s what we’re looking for, as we march forward, but that would be dependent on Phase 3 design, it would be dependent on conversations with the agency, the FDA.
