Jay Luly: Yes sue, there is vaccines and monoclonal antibodies. Maybe I will let Tara Kieffer speak to that one.
Tara Kieffer: Sure. Hi Jay, this is Tara. So, in terms of the vaccines that have been recently approved in adults, we don’t anticipate that having much of an impact. Both GSK and Pfizer have guided towards minimal uptake of their vaccines at least initially in the first season. So, just by the way of example, GSK has sort of guided to expectations to be less than what they saw with Shingrix in the first year. So that was, say 7% in the first full-year. So we don’t expect that to have too much of an impact.
Operator: We have a question from Ed Arce with H.C. Wainwright.
Ed Arce: Wanted to start with the RSV program 323, and the recent results from your Phase 1, including the PK supportive of once-daily. I missed the EC90 multiples that you stated, as well as the nanomolar potency. And then beyond that, I just wanted to ask, if you could opine on how we should think about benchmarking those relative to potential other agents in development or indeed how to indicate or handicap the probability of success?
Jay Luly: So the potency of EDP-323, again, this is the L-inhibitor. It is extremely potent. It is 0.3 nanomolar, so 300 picomolar in terms of an inhibitor. That is good but it is good but not necessarily sufficient. What you want to see is obviously good PK and safety. So those were the two other things that we clicked off in the Phase 1 study. So in the MAD doses, we looked at 200, 400, 600 and 800. So a range of 200 to 800 milligrams and when we looked at the 24-hour trough time point, after a single dose at the low-dose, we saw multiples that were 11x, the EC90 and at the high dose, we saw multiples that were 44x the EC90. So just whopping multiples of that very potent EC90 and we were able to do that in a manner that was very safe and well tolerated.
So, I know Ed, you have focused on infectious disease for a long time. When you have an agent where the potency it takes to sort of take out the bug and you can deliver those concentrations or high multiples of those EC90s safely with either antibacterials or antivirals, it is usually a very significant de-risking step along the way. So I think it bodes well. The next proof in the pudding, I guess goes to when we get inside that human challenge study, which again will be starting early next quarter. And with that, we will actually be able to look at antiviral effects at various doses. So, stay tuned for that. Hopefully that will enroll fairly straightforwardly because the human challenge study recall is in healthy volunteers that we, then infect with RSV.
So it is not a question of seasonality, it is really just a question of bringing in a cohort after cohort of healthy volunteers to do your exploration. So, that will be the next step where we actually sit show hopefully some very solid antiviral activity.
Ed Arce: Well, I agree that these early readouts do give a lot of confidence in the correlations to actual patient results. The other question I had was around the COVID program, and I believe this is a new sort of decision to look for partnerships for Phase 3 once you have completed the ongoing study. I’m wondering if the rapid drop in COVID vaccine demand as described recently by both Pfizer and Moderna impact the potential of the program either for licensing or otherwise?
