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

Jay Luly: Thanks, Ed. Yes, so 323 data in Q2, it’s a standard Phase 1 in healthy trial. But the good news is, when it comes to virals, that tells you an awful lot and can, in fact, do a lot of de-risking of the asset, as you know. So, we’ll be looking at safety, PK, especially PK. Not that safety is not important, but PK is where you really dial in your dose selection for future studies. And there, we always aim for a once-daily dosing, that’s always our target. So, we hope to achieve once daily dosing that gives adequate trough level concentrations at the 24-hour time point to deliver good pressure on the virus in terms of multiples of the EC90. So if we can do all of that, that’s certainly what we’ve done with our other antivirals and our preclinical modeling suggests that we’ve picked doses to achieve that in this study.

So, we’ll soon enough know the answer to that. And then assuming that the data are good, you can think about €“ probably, the quickest way to get any viral data would be to do a challenge study, which you can also use to check antiviral effect, you can look at symptoms, and you can also further would find any dose decisions that you might be wanting to make for other more advanced studies. So, I think that’s the broad layout for the year.

Operator: Thank you. And I show our next question comes from the line of Eric Joseph from JPMorgan. Please go ahead.

Eric Joseph: Good evening. Thanks for taking the questions. Just a couple on 235 in COVID. I’m wondering if there’s a clear sense of the types of endpoints that would be needed to support registration for COVID antiviral. Just given where we are with the vaccine exposure and prior virus exposure, has there been any shift, I guess, from the precedent set by Paxlovid and Lagevrio? And then secondly, assuming compelling data from SPRINT, I just want to get a sense of the sequencing event of events from here between partnering and launching the Phase 3 study? And I guess specifically, whether your cash guidance through fourth quarter next year anticipates full execution of the Phase 3 trial, whether you could do it alone? Thanks for taking the questions.

Jay Luly: Yes. So, I think we’re setting ourselves up to collect SPRINT data, assuming it’s as expected, having discussions with the regulators to design that Phase 3 study. There’s lots of different possibilities in terms of how you could think about that in terms of end points. Maybe I’ll let Tara Kieffer here elaborate on that a little bit further, but with regards to partnering, will €“ that timing will be that timing. And I’m not going to co-mingle that with SPRINT Phase 3 start or data collection. So, we’ll give updates on each of those tracks as updates are relevant. From a cash perspective, we would position ourselves to be able to do that ourselves. Obviously, it depends a lot on what Phase 3 development plan you choose and how those Phase 3 designs are ultimately implemented in terms of trial size, et cetera.

But right now, I think we feel reasonably good about that. So maybe I’ll turn the call off to Dr. Tara Kieffer here. She’s our Senior Vice President of New Product Strategy Development. We’ve been thinking a lot about Phase 3 stuff along with our clinical team about possible endpoints and so forth. Again, we will ultimately select it after discussions with the agency. So nothing that we’re going to declare today, but there’s different possibilities. Tara?