Trevi Therapeutics (NASDAQ:TRVI) reported first-quarter financial results on Tuesday. The transcript from the company's first-quarter earnings call has been provided below.

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Summary

Trevi Therapeutics discussed their adaptive phase 23 design for clinical trials, focusing on patient population, dose selection, and interim analysis to confirm power assumptions.

The company is expanding its team, having added 10 new staff, including a pulmonologist, to support ongoing trials and strategic initiatives.

They are optimistic about their competitive positioning in the RCC space despite potential market entrants, noting strong differentiation and a large unmet need.

Future data readouts are expected in the second half of 2024, with insights from the RCC trial anticipated by the fourth quarter of this year.

Management emphasized their experience and capability in managing multiple programs and resources effectively.

Full Transcript

OPERATOR

Our intentions on using that in an SMDA (Specialty Medical Drug Application) strategy so that we would support approval with that adaptive Phase 2/3 design. So there's going to be details about our patient population, how we're going to use the phase two for our dose selection, confirmation and defining the dose for going into phase three and then pulling up the results from the phase two part of that study with the interim analysis to confirm our power assumptions for the phase three component.

Jim Rowana

I would add too, Jim Rowana we have added probably 10 people in the last since getting our Phase 2B results. We added a really experienced Pulmonologist. We've added several clinical people. So you know, 10 people for us is a lot of hiring and so we have tried to scale appropriately to address the busyness of these trials.

OPERATOR

Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.

Judah Frommer (Equity Analyst)

Yes. Hi guys. Thanks for the update and thanks for taking the questions two for us. I guess just from a competitive standpoint in RCC we have a P2X3 readout coming mid-year. Just curious how you think the landscape evolves for Haduvio if kind of along the spectrum of possible outcomes for that P2X3 readout, I guess if results are unexpectedly strong, what does that do for for your opportunity in RCC? What does it do maybe for enrollment in the RCC trial?

Jim

Judah, thank you for the question. You know, when we look at the competitive landscape, especially Kamlopixent (a competing drug), which we'll be reading out soon, in the next couple of weeks. you know, we're hoping that they are successful here. Right. This is a large unmet need patient population with no approved therapies and definitely a category that can support multiple modalities. And we have strong differentiation with our central and peripheral mechanism of action. And I think what we'll take you through on Thursday in the investor day is exactly how that positions us for success. I'll turn it over. You know, I'll just say on the flip side, if Kamlopixent is unsuccessful within that space, I think we'll have to take a look at, you know, what is our competitive positioning. But we have a really strong efficacy and see what the Phase IIb results say and see what the commercial opportunity lies ahead. But it's still a large unmet need. Patients are waiting for us. And I'll turn it to Jim. Yeah. On the enrollment side, we have our investigators lined up for that study. There's a lot of excitement, There's a lot of patients available to us regardless of what happens in that environment. We're strongly supported by the investigators that we have for the study who really talk about a lot of patients being available and interested in being, I think our different mechanism of action. The data that we've shown, the strength of the data that we have out there still is really the absolute driving force for the interest in being in our study. And our 2B will be done by the time they ever got approval. So it might be a phase three issue to deal with. But yeah, thanks for the question.

Judah Frommer (Equity Analyst)

Great. And then just maybe more high level philosophical just on the ILDs with kind of more inhaled formulation drugs kind of entering or late stage in kind of the IPF and PPF space. A common issue in many of those trials is cough. A common AE in a lot of those trials is cough. So just curious how, you think, you know, the opportunity for haduvio could be impacted by maybe more inhaled therapeutics in the PF space.

Jim

Thanks, Judah. We get this question a lot. I think obviously we're treating more of a chronic cough that's more systemic and now whether the hypersensitization's intertwined with them taking these inhaled products and you might be able to settle that down. That's something that's going to have to be learned over time. I do think, you know, these different therapies are helpful. They'll define the market, they create options. But we can lay alongside all of these. That's why Jim's been busy doing these drug-drug interaction (DDI) studies. But whether we can sort of help with the cough due to their delivery system, I think that will have to be discovered.

OPERATOR

Thank you. Our next question comes from the line of Alexa Deamer of Cantor Fitzgerald. Your line is now open.

Alexa Deamer (Equity Analyst)

Hi, guys. Thanks for taking my question. And congrats on the great quarter. So for the guidance for the data readouts for the upcoming program. So this begins in the second half of 2024, and I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

OPERATOR

Our next question comes from the line of Serge Bellinger of Needham and Company. Your line is now open.

John

Hi, good afternoon. This is John on for surg today. Thanks for taking our questions. So, just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, curious what some of the key checkpoints will be that you're looking for during this analysis. I would imagine it might look somewhat similar to the Intellectual Property (IP)F (Idiopathic Pulmonary Fibrosis) one done during phase two. And in the event of requiring additional patients, just curious how you might expect that to look. And then secondly, on the Intellectual Property (IP) front, I believe you have patents issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvia.

Jim

Yeah. Jim, you want to do the ssre? So the SSRE is exactly what we did with CORAL. It'll be at the halfway point looking for conditional power of 80% of 80%. If the numbers are below that, if the conditional power of 80% at that point is below 80%, we will upsize proportionately. And like we had in the CORAL Design, if there's futility, it will be recognized too. That's going to be down in that 30, 40% range. So I think conditional power of 80%. So it's really what you expected from CORAL is going to be carried over to here and we'll be reporting whether or not we have to stay the same or upsize.

John

Great. Thanks so much for the caller.

OPERATOR

Thank you. Our next question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

Ryan Deschner (Equity Analyst)

Thanks for the question. You have some very interesting dyspnea (shortness of breath) data coming up at ATS later this month in Orlando. How impactful do you think dyspnea (shortness of breath) is as a quality of life metric for IPF on chronic cough patients? And how relevant is potential modulation of dyspnea (shortness of breath) for the RCC and non IPF ILD indications?

Farrell

Yeah, Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point. You know, when you look at the, when you look at the top three most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top three. It's cough, dyspnea and fatigue at the top three. So it doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also I think just the adoption from patients because it's going to be helping them across more than one of the experiences that they have. impacts and payer conversations Right. And payer conversations, it will help. In payer conversations, it'll help justify additional value.

Ryan Deschner (Equity Analyst)

Got it. And then how do you plan to try to minimize placebo in the RCC clinical program and is high potential placebo is much of a concern in the IPF chronic cough and non-IPF ILD indications.

Jim

Right. It's Jim. So, you know, I think we have solid data from our coral study in the IPF population. You know, came in with under 20% placebo response. I think that was expected. I also think that that's probably in the world of chronic cough, that's probably one of the more well behaved populations and expect to see something like that going forward. I think there's precedent here in the RCC (Refractory Chronic Cough) world that the placebo response could be a little bit more variable and a little bit more ranging. We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well controlled trial. So we're doing our best there. I think we are incorporating, at the advice of some of the experts in the RCC space a placebo run in period to try to mitigate any of the response there. The idea there is to look for stability around lower end of cough response. So we are incorporating those things and of course just sort of the rules of thumbs that I'm bringing in from my CNS background where placebo response is always a big concern, is really about trial conduct and making sure that you don't set false expectations, that you don't over promise and things like that that can help contribute to the overall placebo response.

Ryan Deschner (Equity Analyst)

Thank you very much.

OPERATOR

Thank you. Our next question comes from the line of Debanjana Chatterjee of Jones. Your line is now open.

Debanjana Chatterjee (Equity Analyst)

Hi, thanks for taking my question and congrats on all the progress. So looking forward to ats. What are some of the most exciting developments we should look forward to? And I have a quick follow up.

Jim

Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them. So. Hi Deb. I think we have some exciting updates in the oral presentation that will be given by Dr. Phil Molyneux. I mean that's going to be some new sub analyses from our CORAL study. I think there's also going to be some interesting presentations and posters on cough bouts. Our analysis of the cough bouts for both coral and river and it was brought up earlier, but I think our breathlessness data being presented by Don Mailer, who is really one of the key experts in this space is really going to be exciting poster to get out that initial analysis that really shows some benefit here on the breast census piece of things. So I think those are highlights. I think that really adds some new information into the data flow for us.

Debanjana Chatterjee (Equity Analyst)

Appreciate the color and just a quick follow up. So I know of course FVC (Forced Vital Capacity) is not an endpoint that you are pursuing, but given that you'll be following the IPF patients like 52 weeks at least, right in the phase three program, do you expect to see some trends there? And even if that's kind of like a

Jim

a safety endpoint, so we are following FVC. We have it at baseline, we have it throughout the 52 week time period. We will be able to look to see what's there. Our ends are very different than what you expect from an IPF trial, because FVC is highly variable and I think that drives the size of those trials. But all I can promise you is that we will see what we see and report it.

Debanjana Chatterjee (Equity Analyst)

Thank you.

OPERATOR

Thank you. Our next question comes from the line of William Wood v. Reilly securities. Your line is now open.

William Wood (Equity Analyst)

Thanks for taking our questions and congrats on a nice quarter. So just curious when we're thinking about the peers P2X3 readout coming up, I was curious if there's anything specific that you might be looking for in that trial, regardless of whether it's positive or negative in terms of taking forward to the FDA, that you think they could really improve your learnings on your own trials.

Jim

I mean, I'm just going to jump in. Jim, you add any color? Thanks for the question, William. I don't think so. You know, P2X3s have had to kind of chase this path of the highest level of coughers and placebo run ins and highly adjudicate the indication. You know, we've shown data that our drug works broadly in IPF, chronic cough and refractory chronic cough across different cough counts. So I think that we have to be a lot less fussy with who goes into the trial and how we get results. We'll obviously be interested in the placebo effect and how they've controlled that. But those trials were upsized. The bigger trial was upsized twice and that's always tricky. I think they're also managing a much tighter response. So we'll look at it. We're interested. I agree with Farrell. I hope they see some results for patients, but they are guiding towards about a 15 to 20% placebo adjusted change in their coughs. We would expect much better performance of our drug. So we really are looking to be best in class and most refractory patients for our drug. So you know, it's more as Farrell mentioned, just how we position the drug and where we go. But I would say nothing that really impacts our program. We'll learn more from our phase IIB then we'll probably learn from their phase three data.

William Wood (Equity Analyst)

That's helpful. And then one brief quick add on just in terms of, you know, sort of setting our expectations for the for your Key Opinion Leader (KOL) event coming up as well as at ATS (American Thoracic Society). You know, is there anything specific that the FDA may be looking for in terms of guiding for your non IPF ILD related chronic cough trials that you may be highlighting at these that really sort of bolster moving into this and or certain subsets populations as you look to meet with them in the second half. And thank you for taking our questions.

Jim

Well, we are having an ILD expert in the U.S., Dr. Toby Marr, who runs a big ILD center. He's going to speak there. He's got to join us by zoom because he has clinic, but one of the topics we've asked him to cover is why in his judgment an IPF and an ILD patient is the same or not the same as it relates to cough. So you'll hear straight from one of the experts here. Toby's been involved in our program from the beginning. He knows our drug quite well. He actually sat on our FDA call with us. So you'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

William Wood (Equity Analyst)

That's helpful. Thank you.

Jim

Yeah, thank you William.

OPERATOR

Thank you again. If you have questions, please press star 1 1. Our next question comes from the line of Cavaria Pullman of Clear Street. Your line is now open.

Cavaria Pullman

Yes, good evening. Thanks for taking my questions. And just like a follow up on the previous comments you made on the Phase 2B RCC trial design, I was wondering how you are thinking about enrolling a truly addressable patient population to fully de risk the program, particularly given the expectations that many of patients may be P2X3 antagonists. Experience in real world and broadly, just like on a high level, there appears to be an increasing focus on the development progress in IPF and non IPF ILD obviously alongside continued efforts in RCC. How do you think about the relative opportunity across these indications in the context of the evolving treatment landscape and what key challenges in RCC will need to be addressed to fully realize its potential. Thank you.

Farrell

There were a lot of questions there to disentangle. So I'll just kind of start from a strategy perspective. And Trevi has always been led as an IPF sort of. And then adding an ILD led strategy primarily because of our commercial strategy, specialty high pricing, specialty sales force. So that was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC. We did and got very strong data. So I think definitely a commitment to RCC. But it is sort of the third leg of the stool here with regard to the variability in the program and P2X3 responders. Anything, Jim, on that?

Jim

I think. Are you asking there's going to be people who have experience with P2X3 that may be entering in our trial. I mean, I think the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have the requirements to get into the study. They're fair game for coming in. We want people with various experiences. We know this is a refractory condition and people have tried a lot of different things and they may or may not have succeeded on a P2X3, but if they meet our entry criteria, they'll be coming into the trial. So I don't think it really differentiates from any other type of. Of therapy that they have tried in the past. They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Cavaria Pullman

Got it. Thank you.

Jim

Thank you, Kaveri.

OPERATOR

Thank you. I am showing no further questions at this time. This concludes our question and answer session. I would now like to turn the conference back to Jennifer Good for closing remarks.

Jennifer Good

We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

OPERATOR

This concludes today's conference call. Thank you for attending. You may now disconnect.

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