Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q1 2023 Earnings Call Transcript

Tara Kieffer: Sure. Thanks, Jay. Hi Eric, thanks for the question. This is Tara. So, I think if you think about Phase 3 trials for COVID, there’s a number of different strategies that one could think about, including different patient populations. So a high-risk patient population, standard risk population. There are currently Phase 3 studies going on in both of those populations, also ones that have mixed populations. In terms of endpoints, there are studies looking at hospitalization and death. Obviously, the rates are lower than what they were at the peak of the pandemic with different variants coming along now. However, some of the strategies being used would include high-risk patients that really focus in on those €“ a subset that have a higher risk and really elevating that event rate.

Other endpoints that are being used are looking at symptoms. So has an ongoing Phase 3 trial now that’s looking at a symptom endpoint, and they had shown data from their other Phase 3 trials being run in Asia where they did see a significant effect on symptoms looking at a subset of five symptoms that were shown in their Phase 2b study to be more correlated with an effect. So, I think there’s a number of different strategies one can use. We’re obviously thinking about all of those, among others, and having discussions with regulatory agencies as we move forward to our next phase.

Operator: Thank you. And I show our next question comes from the line of Roy Buchanan from JMP Securities. Please go ahead.

Roy Buchanan: Hey, thanks for taking the question. I guess one on 514. Any changes to your confidence in the capsid inhibitors? Doesn’t sound like it. Maybe more concretely, are you shifting to look more externally or internally versus your prior expectations, I guess, for partnering candidates? I’m just thinking of J&J’s comments around their hepatitis B program. GSK going into Phase 3 with just an ASO, and then any change to your thinking? Thanks.

Jay Luly: No change to the thinking. I think our core inhibitors are still an impactful class of HBV drug. I think, ultimately €“ whereas we’re doing a little bit internally, we’re looking externally at the landscape for other possible options. But I also think it’s important while we’re in sort of this phase to be thinking about other data sets that are going to be ultimately coming from others, which may inform potential other combination ingredients. And so I would say, we’re not in a hurry to push something ahead just to do it. We’re being very thoughtful and disciplined on this front. And until or unless we’ve come up with that solution, we’re not going to just push a dual-acting regimen forward in clinical development and spend that money and manpower on it. So, I think it’s going to be a little bit more watching and analyzing and a little bit of doing.

Operator: Thank you. And I show our next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Unidentified Analyst: Hi, this is Amy again. Thanks very much for taking our follow-up. Just wanted to get your thoughts on €“ so Pfizer recently made some interesting comments that competitor COVID antivirals won’t be on the market until around 2025, and they could show worse efficacy because of the lower event rate. Would love to get your thoughts on these comments.

Jay Luly: Well, it’s €“ anything is possible. I think, Paxlovid today, if you put it in a clinical trial, which show probably a lower event rate as well. But you €“ again, you can never know how to speculate on that. I think the variance continued to change. I think people will be looking at different things, but at the end of the day, we think you can show clinical significance and important patient populations and with an easier-to-use drug that doesn’t have some of the liabilities I mentioned earlier on the call. So either way, I think there’s going to be room for other drugs out there that are more conveniently dosed.