Trevi Therapeutics Inc. Q1 2023 Earnings Call
Speaker 1: increased anxiety. The chronic cough in IPF is also hypothesized to potentially enhance activation of pro-phibiotic mechanisms and disease worsening.
Speaker 1: We are planning to conduct two studies in parallel during this next phase of development in our IPF chronic cough program. The first is a phase 2b dose ranging trial that will study three active doses of Hidubio and placebo. The doses we are planning to study are 27, 54, and 108 milligrams.
Speaker 1: in a timely manner. As you may be aware, there is a lot of development work going on with antifibrotics and IPF patients.
Speaker 1: So we expect that enrollment will be competitive and we are planning for that scenario. We have finalized the protocol for the DOS Ranging Study and are preparing for various international submissions to regulatory authorities.
Speaker 1: We have also engaged our CRO and are in the final stages of country and site selection.
Speaker 1: We are planning on initiating this study in the second half of this year.
Speaker 1: In parallel, we are planning for a Phase 1B Respiratory Physiology Study.
Speaker 1: This is not something we have seen in our safety data across our various studies to date, and there is literature that suggests that mixed agonist and antagonist have a sealing effect on the impact on respiration.
Speaker 1: However, given the respiration impairment of the IPF population, it is important that we characterize to what degree if any, or drug causes respiratory depression in this patient population.
Speaker 1: Previous planning to conduct a Phase I B in patient study in IPF patients with cough that have varying levels of disease severity. To determine if we see any clinically significant impacts on respiratory depression, this study will help define the patient population for our pivotal program and ultimately the label.
Speaker 1: We have received FDA feedback on the Plan Phase 1B study and are finalizing the protocol and preparing for the IND submission. We expect to initiate this study in the second half of this year as well.
Speaker 1: In addition to the preparations in IPF cough, we are also developing a protocol for a face-to-study in refractory chronic cough, also known as RCC.
Speaker 1: We believe that because Hadoo works both centrally in the brain and peripherally in the lungs, Hadoo has the potential to provide therapy across a range of chronic cough indications regardless of what the underlying disease is. We expect that this trial will look a lot like the canal trial, which was a dose escalating crossover design.
Speaker 1: and we expect to enroll approximately 60 subjects.
Speaker 1: There have been a lot of trials in RCC with only one mechanism which has seen some success, the P2X-3s, which mechanistically work peripherally in the long. However, we believe there's still a significant opportunity for a mechanism that works both centrally and peripherally and has the potential to provide strong and consistent efficacy.
Speaker 1: in the most difficult to treat cough patients.
Speaker 1: We are leveraging the learning from the prior development work in RCC by other companies as we design our own study. Our cost data to date continues to garner a lot of attention at upcoming medical conferences with oral presentations of the data accepted at both the American Theraphic Society meeting beginning the end of next week.
Speaker 1: as well as the American Crop Conference being held in June . We have also finalized a manuscript on the Canal Trial Results and have submitted it for publication.
Speaker 1: I think this speaks to the importance of the unmet medical need in these difficult to treat IPF patients and the medical community's interest in our program across cop indications.
Speaker 1: The other indication where we have ongoing work is for the treatment of Prygonodularis or PM, which is a serious and debilitating disease characterized by papules and nodules on the skin as well as severe itching.
Speaker 1: In June of last year, we reported positive data in the Phase 2B-3 Prism trial and PN. The trial achieved statistical significance on the primary and all key secondary endpoints.
Speaker 1: During the first quarter of 2023, we completed the one-year open label extension study that was associated with Prism. We are currently analyzing the data from that study and will then seek an end-of-face to meeting with the FDA, which we expect to have later this year. After this meeting, we will determine next steps for the program.
Speaker 1: Finally, we are conducting a human abuse potential study, which is required for an NDA filing. Note that the parental version of NALB UFIN is currently unscheduled in the US by the Drug Enforcement Agency or DEA. The objective of this study is to compare the likability or abuse potential of oral NALB UFIN.
Speaker 1: to an active comparator, which is the torphenol for this study. Butorphenol is a scheduled for drugs. The study is being conducted in two parts with the objective for the first part to characterize the various butorphenol doses and choose a dose appropriate for comparison against oral now-view-fein in part two.
Speaker 1: We have completed part one of the study and have selected the detour for all those for the second part of the study.
Speaker 1: The second portion of the study is a randomized double blind active and placebo controlled five-way crossover design to determine the abuse potential of three doses of oral now-be-ufine relative to the selected dose of butrofenol as well as placebo.
Speaker 1: Assuming neither of these two items causes a significant delay, we expect top-lying results from the Human Abuse Potential Study by the end of this year. In closing, we are focused on execution to get these studies up and running. We will announce studies as they are initiated and provide more details on the study design, expected timelines, and the all-important name of the trial. I will now turn it over to Lisa to review our financial results, then we will open it up for any questions that you may have.
Speaker 1: For the first quarter of 2023, we reported a net loss of 6.4 million compared to a net loss of 7.3 million for the same quarter in 2022. R&D expenses were 5 million during the first quarter of 2023 compared to 4.6 million in the same quarter in 2022. The increase was primarily due to increase consulting and professional fees related to startup activities for the three planned chronic off trials. This was offset by a decrease in clinical development expenses, reflecting the completion of both the blinded portion of the Phase 2B-3 Prism trial and the Phase 2B-3 Prism trial.
Speaker 1: Subsequent to the end of the first quarter, we elected to pay off our term loan early. The amount paid was 6.5 million and was previously classified as current on our balance sheet, because the final payment was due in the first quarter of 2024, according to its terms. The loan was with Silicon Valley Bank, now a division of first citizens bank, and it included restrictions related to keeping our corporate cash, cash equivalents, and marketable securities either at or managed by SVB. Given the recent events at SVB, we wanted to free ourselves of these restrictions.
Speaker 1: Our cash runway guidance remains unchanged since it had previously incorporated the paydown of the note in accordance with its terms. Accordingly, our cash, cash equivalents, and marketable securities will enable us to fund our expenses into 2026.
Speaker 1: In the first quarter, we burned approximately 9 million of cash. That included completing the clinical work on the PN Open Label Extension Study and conducting part one of the Human Abuse Potential Study.
Speaker 1: This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A. We will now begin the question and answer session. To ask the question, you may proceed to start in one your touch tone phone. If you're using a speaker phone, please figure out your hands up before messing the keys. To a dryer question, please proceed to start in two. At this time, we will pause on the material of the Sumbar roster. Our first question will come from Annabelle, Simeenie with Tiffle. You may not go ahead.
Speaker 2: Hi, this is Stacy dialing in for Annabelle. Congrats on the quarter and just a few questions on our end. So the first is what was the rationale behind the decision to dose up to 162 in the phase one B respiratory trial and IPF when the phase two B are at lower doses.
Speaker 3: Yeah. Okay. Thank you, Stacy, for the questions. So the phase 1B trial, we're still finalizing the study design. Our current plan is to only dose to 108 milligrams, but that's some of the discussions that have been going back and forth with the FDA. So we think we only need to go to 108, but we'll see when we finalize it. As far as the RCC indication, yeah, I mean, we obviously got a lot of inbound interest. I think I'm going to state the obvious, but GSK certainly validated the importance of cough as a market and the end met need there.
Speaker 3: I think with refractory chronic cough as well, there's just not been a lot of success there. You have the two players with the P2X3. So we kept quite busy from an investor perspective. We already are in a lot of discussions around sort of with various strategics. Actually, I'll see several more over the next couple of months at conferences. So yes, I think that got everybody.
Speaker 1: Our next question will come from Serge Ballinger with Needham and Company.
Speaker 4: You may now go ahead.
Speaker 5: Good afternoon. Just one question for us today. I think you received.
Speaker 5: a new patent for now, Vufin over the quarter. Maybe just give us an update on the overall IP for the product.
Speaker 5: patent for now, but you've been over the quarter. Maybe just give us an update on the overall IP for the product. Yeah.
Speaker 3: Thank you, sir. Yeah, it was an important patent for us. We had filed a broad application. So we have three layers of patent coverage. One is the formulation patents that have been in place for the product. Those start to expire in roughly 2029. So the primary coverage that will extend that is through method of treatment patents. And we have a big broad application that we filed around.
Speaker 3: various neurological cough. What we did was take the data from the IPF canal trial and actually pull out claims and prosecute a specific patent based on the dosing, the data, et cetera. And that patent was issued. It cooly has helped us with that. We consider it to have broad claims in the patent.
Speaker 3: elderly that will be in the label around dosing. And you know, those all have to play through, but if those get issued and actually into the label, that would move protection out even a couple years beyond that. So getting that method of treatment and IPF chronic cost was super important for us.
Speaker 6: Thank you. Yeah, thank you, sir.
Speaker 1: Hi, this is Max Joanne Cook-On for Thomas Smith. Just one quick question from Max. So what are the getting factors to initiate a Phase II trialling RCC and a Phase II B study in chronic cough in IPF? Clearly, like you mentioned, packaging material shortage was like one of the factors. Is that issue being soft? Yes, so just to be clear, the materials issued I mentioned is butorphinone. Only effects are human abuse potential study, so that does not affect our Phase II B dose ranging or our refractory chronic cough. We have plenty of drug supply.
Speaker 3: smoothly it'll be sooner and we get any comments back will have to adjust the protocol and go back to them so it could be a little later in the second half.
Speaker 7: got it thank you
Speaker 7: Thank you.
Speaker 8: Our next question will come from Mayank, Mantanny, with the Riley securities. You may not go ahead. Hi, this is William on from Mayank. Congratulations on the very nice quarter and thank you for taking the question. So a couple from us. Just a little.
Speaker 8: regulatory level, I guess. Could you remind us of the current IND status for Hadovio in chronic costs and how that's progressing?
Speaker 3: around this Phase 1B respiratory physiology study. That will be our IND opening study. So we're preparing that now. And that should be submitted shortly with the agency. But fortunately, we've had a lot of good dialogue with them about the program. So we should be able to move that through and hopefully get the IND open and get that study moving along.
Speaker 8: Got you. Very helpful. And just thinking about RCC, when in terms of the patient population that you're planning to target, are you going completely broad, sort of incorporating everybody or trying to do more to targeting specific subgroups that you think could do? If you have a job that you may work best in and then maybe building out from there or some combination of that.
Speaker 3: but we'll probably do a two-to-one enrichment strategy of, you know, coffers greater than 20 and then some portion of coffers that are in the 10 to 19 range. We want to be mindful though because Bellis is out running these two pivotal studies with this enrichment criteria of greater than 20.
Speaker 3: If we don't have that as a requirement, our studies will end up with all the mild coffers, so we don't want that to happen either. So we have put in some parameters around that to get a more enriched population, but we will also study some of the lower coffers, which they're doing as well. They're doing a 3-to-1 randomization. Right. Make sense. And then one quick last one. I know you've made...
Speaker 3: I'm actually waiting to see that data myself, our physician who's driving that along is sort of synthesizing that down and we'll share it with the team. Where that gets presented, I think the most obvious next big Durham conference is the ADV, which is in the fall in Europe . But we probably will do something in one of our press releases with some of the top line that we saw because people I know people are interested in that.
Speaker 3: As far as strategic conversations, we continue to be active there and move those along. But as we said, you know, we as well want to have our end of phase two meeting. So we clarify exactly what's left in this program. So we certainly have been in conversations.
Speaker 1: We know the short list of interests. I think it's a matter of working our way through that FDA meeting and then reassessing at that point based on what we learn. Got it. That's all from us. Thank you for taking our questions again and congratulations again on a good quarter. Thanks. Thank you.
Speaker 9: Our next question will come from Shawn Kim with Jones Trading.
Speaker 9: Next question, we'll come from Sean Ken with Jones Trading. Him and I go ahead.
Speaker 7: Yeah, hi. Thank you for taking my questions. So I guess one question on the modularity program. So what kind of feedback would you be expecting from the end of phase two meeting in order for you to kind of move forward with the program? And I guess my second question is on the RCC.
Speaker 3: potentially partnering up to get you to become a company against the larger platforms. Thank you. Yeah, so thank you, Sean. On PN as far as feedback, the key question that we want to confirm is that the Phase II B3 serves as one of our two pivotal studies. The agency agrees that we only need one additional trial.
Speaker 3: We're going to present the protocol for the next trial, which essentially looks just like the trial we just ran, possibly a little bit longer. So we just want to confirm that there's one more study, here's what it looks like. There's some little CMC questions to nail down, but nothing too major. So it's really pretty, it's all really around that, that we're sort of there.
Speaker 3: As far as RCC, I don't think it's changed our thinking at all. I think we're continuing to sort of refine in our own minds where we're going to compete. And I think where the RCC market comes out for us is, you know, we're looking at the severe difficult to treat patients. P2X3 is working about half the population, but don't
Speaker 3: think will set us up for nice premium pricing and also other interstitial lung diseases. We think that we may be able to hold that at a pretty strong level for picking up the failures in the chronic cough market, which is about half that market. So it's still a big opportunity. So that's how we think about it as far as partnering that out.
Speaker 3: You know, we say to partners all the time when they ask about that. I mean, we're a single asset company and, you know, COF is our lead focus. So if people want the rights in the US for that program, they're going to have to buy Trevvy. You know, we'll look at sort of Japan or possibly Europe , but in the US they're just going to have to buy the company.
Speaker 3: time when they ask about that. I mean, we're a single asset company and you know, COF is our lead focus. So if people want the rights in the US for that program, they're going to have to buy Trevi. You know, we'll look at sort of Japan or possibly Europe , but in the US they're just going to have to buy the company. Okay, that's very helpful. Thank you very much.
Yeah, thank you, Sean. Again, if you have a question, please press star then one. Our next question will be a follow-up from Annabelle Simeone with people. Thank you.
You may now go ahead. Hi, sorry about that. Our question was previously answered. Thank you.
I'm showing no further questions. This concludes our question and answer session. I would like to turn the conference back over to Jennifer Good for any calls or remarks.
We would like to thank everybody for participating in today's call. We have several upcoming conferences and medical meetings that we are participating in before summer gets fully underway. You can see them detailed in our earnings release issued today. I hope to see some of you at these meetings. Thank you.
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