Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2022 Earnings Call Transcript

Sean Kim: Okay. And just one quick follow-up question on the Phase IIb dose ranging study. So now that the trial is set to initiate in second half ’23, what would be the expectations for the top line readout in terms of timing?

Jennifer Good: Yes, Sean, I’m going to defer sort of giving hard guidance on that until we actually initiate it. I mean, David told you in sort of his last answer that we’re planning for roughly a 12-month recruiting process. It’s going to be a 6-month dosing — or 6-week dosing, I’m sorry. So it’s not a long trial. But I thought I want to wait until we actually get it initiated and then we’ll give some better time line guidance. But that allows you to kind of do the math in your head and think about where you think it could come in. Thank you for your report this week. I appreciate it.

Operator: Our next question comes from Sir Mamtani with B. Riley Securities.

Mayank Mamtani: I appreciate the level of detail. So about the CANAL abstract being accepted at PDS, if you could comment on that. But also — my understanding is that there’s the PAciFy trials as well as expected from Dr. Molyneaux both for morphine, post the test in IPF. Do you have any thoughts on your expectation for that on any relevant safety efficacy data points that could be relevant to Haduvio? And then I have a follow-up.

Jennifer Good: Yes, sounds good, Mayank. So our poster, I know exactly what it’s about. I know they’ve been tugging and pulling on all different looks at the data. So David, I don’t know. Do you know exactly what’s being covered there? Might be the anti-fibrotic data but I’m not sure. Go ahead.

David Clark: Yes. There will be additional analyses, including some additional end points that haven’t been disclosed before. That’s right presented there.

Jennifer Good: Yes. And I think, Mayank, you were asking about the Philip Molyneaux trial in the U.K. around morphine. Is that what you were asking me about and how I think that’s relevant to our program?

Mayank Mamtani: That’s correct. And I think there will be some data at APS around that also.

Jennifer Good: Yes. No, that’s great. I think from our perspective, we’re excited about that study because I think it just builds more critical evidence around the mechanism here in this whole opioid pathway. Morphine has its own set of issues, certainly around respiratory depression and also just the whole scheduling, Schedule II. But from our perspective, we think it just continues to build critical scientific evidence around the pathway; so I think it should work. They use low doses of morphine now. And as I’ve heard from several KOLs, it’s really the only thing that works in cough. It’s part of what drew us to the space. But we felt that, first of all, we work on 2 receptors and we felt that because of more of the safety profile and abuse addiction profile around our drug, that we could be a much better chronic option.

So I’m excited to see it. I would expect that it should work. And I don’t feel threatened by it because of all the things I just mentioned to you. And they’re going to have a hard time patenting that. So likely people may use it off label but there’s other challenges with prescribing morphine in today’s environment.

Mayank Mamtani: Got it. And then about the 2 studies, Phase IIb IPF and RCC, could you just comment on the different placebo responses you’re factoring in? And obviously, based on your learning from CANAL but also some of the dry run going on P2X3 development programs?