Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2024 Earnings Call Transcript

And that’s if we either have a variance, which is not — is higher than we expected or the effect size is smaller. So for example, if the effect size — the increasing it to the top sample size of 400, that’s 100 per group, if that is necessary, that would allow us to detect a clinically relative effect size of 25% on top of placebo. So that’s how we framed the SSRE characteristics.

Mayank Mamtani: Super helpful. And then on the Phase II RIVER study moderate versus severe cohorts, are they equally split in terms of enrollment? And would you be looking to present data in second half in both of those cohorts or you do sort of a total pooled analysis? And then lastly, what’s the program for this half study presentation, obviously, great to see the 75% enrollment achieved, but it does have a relatively short follow-up. So just curious if that would be a press release or an event or KOL event. If you could clarify that. Thanks again for taking our questions.

Jennifer Good: Yes. Thank you, Mayank. So far, so good on the enrollment in RIVER, we’re seeing sort of equal numbers in both moderate and severe. Obviously, we won’t finish the study until we get everybody in. We will — we do plan to report that out as part of our top line data. So that won’t come later. That will be part of our top line data reported out. As far as the form for human abuse potential, we’re sort of working through that. But I think what we’re working towards is a press release and then also doing a call with probably an expert or two on the phone that works in this area regularly. So we’ll present the data on our end, but then also open up the call to folks like you to be able to ask whatever questions you’d like around the data. I mean, hopefully, it’s clear and sort of not a lot to discuss, but that’s also encouraging and allows you guys the opportunity to sort of confirm that yourself. So that’s the current plan that we are working against.

Mayank Mamtani: Understood. Looking forward to it. Thank you.

Jennifer Good: Good. Thank you.

Operator: I’m not showing any further questions. This concludes our question-and-answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.

Jennifer Good: Thank you. We are expecting a data-rich year with regards to our clinical trials for Haduvio. We see an exciting road ahead for Trevi, and we are locked down on executing good quality trials on time. We will be participating in several investor conferences over the next couple of months as listed in our press release and look forward to seeing many of you there. Thank you for joining today’s call, and we are available after the call for any follow-up questions you may have.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.