Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q1 2023 Earnings Call Transcript

Janet Hammond: Sure. Thank you. It is an interesting question. I think that where we are is that, obviously, we are going to have to see what the overall hospitalization rate is and this is the one of the points for the interim analysis is to determine what the hospitalization rate is and whether we need to upsize the study in order to have a sufficient rate of hospitalization, but not unblinding that. But just understanding what that hospitalization rate is. And so that is the idea behind the adaptive design. I think with regard to seropositive. It is an interesting, but I think a moving target isn’t that we know that for the most part, almost everybody has seen COVID at this time, and therefore is likely to be seropositive.

We believe that in the more vulnerable patient population, that antibody F effectiveness probably wins over time more quickly than for others. And I think there have been some interesting articles, actually, in the last week or two, again, looking at the efficacy of the Omicron booster, and that sort of thing and again, I think demonstrating that there is very rapid waning immunity to the vaccine as well as to natural infection. And I think as the virus continues to evolve with new strains coming through, it is likely that immune evasion is likely to continue. But it is impossible, obviously to predict with any certainty what the hospitalization rate is likely to be as a result, and that is really the basis for why we have designed the study in that way.

I think, firstly, from the point of the population, which is the most vulnerable to hospitalization. So I think it is likely to be higher in that patient population. And then secondly, gave us to Canada study and numbers necessary to accommodate a lower hospitalization rate.

Jean-Pierre Sommadossi: On the first question, as we have always indicated, we are targeting an NDA. And if the UAE the data will be sufficient in the – that would be wonderful. But let’s not forget that what we are targeting is an NDA, as we had indicated also, that the FDA has indicated in writing that this trial SUNRISE-3 will be sufficient for a an NDA filing. Janet, do you want to add anything?

Janet Hammond: No, I think you have covered as well. Thank you.

Operator: Our next question comes from a line of Tim Lugo with William Blair.

Tim Lugo: Thanks for taking the questions. Maybe I will switch to HCV. So you mentioned the ability to reduce the dosing for but not the severe? What kind of dose regimen do you think you can achieve and the ongoing Phase 2 going to inform that?

Jean-Pierre Sommadossi: Look that is a good question Tim. We want to have a better view with the clinical data on the leading course. We have a collaboration with as you know, is the goal on viral kinetics and that is where the analysis of those viral kinetics will really help us in determining our short we can go in terms of treatment duration.

Tim Lugo: You said that at the end of this phase 3.

Jean-Pierre Sommadossi: Yes basically what we will do is obviously feel that we have a very good profile with eight weeks, better than the standard-of-care as you know the great safety especially you see the difference when we are talking now, with the NS5A, a very inside – the field as I’m sure you open the – is very different now than six or seven years ago when those in those NS5A events actually were not as extensive as they are today. And we believe that this is going to play a major role in the differentiation of our combination, a lot more potent against any of those variants as compared to a for example. So and we will see as soon as we have the vowel kinetics even shoulder we can go them the eight weeks.

Tim Lugo: Thank you so much.

Operator: Our next question comes from Roanna Ruiz with SVB Securities.