Q2 2024 Trevi Therapeutics Inc Earnings Call
Speaker Change: [inaudible]
Operator: Good afternoon, and welcome to the Trevi Therapeutics Second Quarter 2024 Earnings Conference Call. At this time, all participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your phone. To withdraw your question, please press star then 2.
Speaker Change: Good afternoon, and welcome to the Trevi Therapeutics second quarter 2024 earnings conference call.
Speaker Change: At this time, all participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.
Speaker Change: To ask a question, you may press star then 1 on your phone. To withdraw your question, please press star then 2. Please note this event is being recorded.
Operator: Please note this event is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the SAAP, Harbor Act, SAAP Harbor of provisions under the private securities, litigation reform act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important facts, including those discussed in the risk factor section of the company's most recent quarterly report on Form 10-Q, which the company filed with the SEC this afternoon.
Speaker Change: Various remarks that management makes during this conference call about the company's future expectations, plans and prospects
Speaker Change: constitute forward-looking statements for purposes of the Safe Harbor Act, Safe Harbor of Provisions under the Private Securities Litigation Reform Act of 1995.
Speaker Change: Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of the company's most recent quarterly report on Form 10-Q , which the company filed with the SEC this afternoon.
Speaker Change: In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date.
Speaker Change: While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its views change. I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO . Please go ahead.
Operator: In addition, any four lucky statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update before looking statements at some point in the future, the company specifically explains any obligation to do so, even if it's used change Analysis and the Conference over to Jennifer Good, Trevi's President and CEO. Please go ahead.
Jennifer Good: Good afternoon, and thank you for joining us for our second quarter 2024 Earnings Call and Business Update. Joining me today on this call are my colleagues Lisa Delfini, Trevi's Chief Financial Officer, and Dr. David Clark, Trevi's Chief Medical Officer. I will give an update on the progress in our clinical trials, and Lisa will give a brief financial update. Then, all three of us are happy to answer any questions that you may have.
Jennifer Good: Good afternoon and thank you for joining us for our second quarter 2024 earnings call and business update. Joining me today on this call are my colleagues Lisa Delfini, Trevi's Chief Financial Officer, and Dr. David Clark, Trevi's Chief Medical Officer.
Jennifer Good: I will give an update on the progress in our clinical trials, and Lisa will give a brief financial update. Then the three of us are happy to answer any questions that you may have.
Jennifer Good: This has been a fun but busy quarter at Trevi as we continue to execute against our clinical development plans for both chronic coughs in idiopathic pulmonary fibrosis, or IPF, as well as refractory chronic cough, or RCC. We have a number of data readouts expected by year end and are hoping to build on the strong efficacy data we saw in our Phase 2a trial in IPF chronic cough. To support this fast pace and focus on execution, we continue to bolster our team, and we're happy to announce in April the promotion of Dr. Meg Garron, who is key in progressing the clinical development of Kamla Pixant while at Bellis Health. Meg is overseeing our River Trial day-to-day and has already started looking ahead to planning for our next trial. She has been a great addition to the team.
Speaker Change: This has been a fun, but busy quarter at Trevi as we continue to execute against our clinical development plans for both chronic cough and idiopathic pulmonary fibrosis or IPS as well as refractory chronic cough or RCC.
Lisa: We have a number of data readouts expected by year-end and are hoping to build on the strong efficacy data we saw in our Phase 2a trial in IPF chronic cough.
Speaker Change: To support this fast pace and focus on execution, we continued to bolster our team and were happy to announce in April the hire of Dr. Meg Guerin, who is key in progressing the clinical development of Camlipixent while at Bellis Health.
Maggie: Maggie is overseeing our River trial day-to-day and has already started looking ahead to planning for our next trial. She has been a great addition to the team.
Jennifer Good: Let me provide a brief update on our clinical trials, beginning with our Phase 2A River trial in our CC, which is expected to read out in the fourth quarter of this year. RCC is a debilitating disease that affects approximately 2-3 million US adults and is defined as a persistent cough lasting greater than eight weeks despite treatment for an underlying condition or where no underlying condition exists. With a lack of any approved therapies for our CC and the U.S. and several drug-candidate failures, there continues to be a significant unmet need and an urgency from patients and providers for new therapies. We believe our key point of differentiation for Hadoobio is the mechanism of action, which works synergistically both centrally in the brain and peripherally in the
Speaker Change: Let me provide a brief update on our clinical trials, beginning with our Phase 2a River Trial in RCC, which is expected to read out in the fourth quarter of this year.
Maggie: RCC is a debilitating disease that affects approximately 2-3 million U.S. adults and is defined as a persistent cough lasting greater than 8 weeks, despite treatment for an underlying condition or where no underlying condition exists.
Maggie: with a lack of any approved therapies for RCC in the U.S. and several drug candidate failures. There continues to be a significant unmet need and an urgency from patients and providers for new therapies.
Speaker Change: We believe our key point of differentiation for Hadubio is the mechanism of action, which works synergistically both centrally in the brain and peripherally in the lungs.
Jennifer Good: We believe this mechanism has the potential to work more broadly in RCC patients and potentially have a stronger effect across the broader range of baseline cough counts than peripheral-only mechanisms. Our RCC trial is the standard Phase 2a crossover design that has been conducted across several COPS trials run to date and is planned to enroll approximately 60 patients. These patients will be randomized with a one-to-one stratification, or approximately 30 in each arm, between those with 10 to 19 coughs per hour, or moderate cough, and those with greater than or equal to 20 coughs per hour, or high cough.
Maggie: We believe this mechanism has the potential to work more broadly in RCC patients and potentially have a stronger effect across the broader range of baseline cough counts than peripheral only mechanisms.
Speaker Change: Our RCC trial is the standard Phase 2a crossover design that has been conducted across several COPS trials run to date and is planned to enroll approximately 60 patients.
Maggie: These patients will be randomized with a one-to-one stratification or approximately 30 in each arm between those with 10 to 19 coughs per hour, moderate cough, and those with greater than or equal to 20 coughs per hour, or high cough.
Jennifer Good: This trial has been progressing nicely, and we now have approximately 80% of the subjects enrolled. Based on the current run rate, we expect to report data from this study in the fourth quarter of this year. However, I want to note that we currently have an imbalance in the number of enrolled subjects between the two stratification arms, i.e., the 10 to 19 and greater than 20 cost.
Speaker Change: This trial has been progressing nicely, and we now have approximately 80% of the subjects enrolled. Based on the current run rate, we expect to report data from this study in the fourth quarter of this year.
Speaker Change: However, I want to note that we currently have an imbalance in the enrolled subjects between the two stratification arms. IE the 10 to 19 and greater than 20 cough counts.
Jennifer Good: The enrollment between the two arms has fluctuated throughout the study. This is important data to inform future development, and there may be a scenario where we get to our overall planned N of 60 but keep the study open a little longer to balance the odds. We are excited to complete the enrollment of this study and report the data in this important chronic cough condition. Next, an update on our LEAD program in IPF chronic costs.
Speaker Change: The enrollment between the two arms has fluctuated throughout the study. This is important data to inform future development, and there may be a scenario where we get to our overall planned N of 60, but keep the study open a little longer to balance the arms.
Maggie: We are excited to complete the enrollment of this study and report the data in this important chronic cough condition.
Jennifer Good: IPF is a serious end-of-life disease. Chronic cough is reported by approximately 85% of patients suffering from IPF and has significant physical, psychological, and social impact. Cross-contamination may also be a risk factor that plays a role in the progression of the underlying.
Maggie: Next, an update on our LEAD program in IPF chronic cough. IPF is a serious end-of-life disease. Chronic cough is reported by approximately 85% of patients suffering from IPF and has significant physical, psychological, and social impacts.
Maggie: Koch may also be a risk factor that plays a role in the progression of the underlying disease.
Jennifer Good: The constant lung injury, microtears, and inflammation caused by persistent coughing may lead to worse health outcomes for patients. With no currently approved treatment options for chronic cough and IPF, patients and providers have an urgent need for new therapy. Our IPF chronic cough trial, Coral, is a phase 2B parallel arm dose-ranging study that will investigate three active doses of Hadoobio and placebo. The study is a six-week trial with approximately 160 patients. We are conducting this study in multiple countries and sites to be able to complete enrollment in a timely manner. We now have the majority of our sites activated, and enrollment is progressing nicely.
Maggie: The constant lung injury, micro tears, and inflammation caused by persistent coughing may lead to worse health outcomes for patients.
Jennifer Good: We have great relationships with the investigators in the trial and are communicating with them frequently to ensure our study is top of mind. The next milestone in this study is to conduct a sample size re-estimation, SSRE analysis, when 50 percent of the patients complete. This analysis will be done by an unblinded statistician external to the company who will rerun the power calculations using actual data.
Maggie: With no currently approved treatment options for chronic cough and IPF, patients and providers have an urgent need for new therapies.
Speaker Change: Our IPF Chronic Cough Trial, CORAL, is a Phase IIb parallel-arm dose-ranging study that will investigate three active doses of Haduvio and placebo. The study is a six-week trial in approximately 160 patients.
Maggie: We are conducting this study in multiple countries and sites to be able to complete enrollment in a timely manner. We now have the majority of our sites activated, and enrollment is progressing nicely.
Speaker Change: We have great relationships with the investigators in the trial and are communicating with them frequently to ensure our study is top of mind.
Speaker Change: The next milestone in this study is to conduct a sample size re-estimation, SSRE analysis, when 50% of the patients complete.
Speaker Change: This analysis will be done by an unblinded statistician external to the company who will rerun the power calculations using actual data.
Jennifer Good: We will get very limited information back, but we will be informed of one of the following three outcomes. One, continue on as planned with the current planned number of patients, reconfirming the original powering assumption. 2. The drug is working within the pre-specified promising zone, but will require an increase in the number of patients to maintain the power. Or 3.
Speaker Change: We will get very limited information back, but we will be informed of one of the following three outcomes. One, continue on its plan with the current plan number of patients, we confirming the original powering assumptions.
Speaker Change: Two, the drug is working within the pre-specified promising zone, but will require an upsize in the number of patients to maintain the power. Or three, the drug is not working in the pre-specified range and the company should consider stopping.
Speaker Change: We will announce the results of this analysis, and we have the information, which we expect in the fourth quarter of this year.
Speaker Change: We continue to expect top-line data for the full study in the first half of 2025, subject to the result of the SSRE.
Speaker Change: We also are conducting two important supportive studies this year, the Human Abuse Potential, or HAP, study, as well as the Respiratory Physiology study. I will give you a quick update on both.
Jennifer Good: The HAP study is currently 95% enrolled and will require one more cohort of dosing to complete. We expect complete enrollment and dosing in the third quarter, with data from this study reported in the fourth quarter. Finally, we have initiated a phase 1 respiratory physiology study, which is being conducted to systematically measure respiratory function at varying levels of disease severity and IPF to help determine our phase 3 patient population. Currently, we have excluded sleep-disordered breathing patients in our clinical studies, and we want to better characterize the safety overall in the patient population.
Speaker Change: The HAP study is currently 95% enrolled and will require one more cohort of dosing to complete.
Speaker Change: We expect a complete enrollment and dosing in the third quarter, with data from this study reported in the fourth quarter.
Speaker Change: Finally, we have initiated a phase 1 respiratory physiology study, which is being conducted to systematically measure respiratory function in varying levels of disease severity and IPF to help determine our phase 3 patient population.
Speaker Change: To date, we have excluded sleep-disordered breathing patients in our clinical studies, and we want to better characterize the safety overall in the patient population.
Jennifer Good: The protocol has been approved in both the U.S. and the U.K., and the study has initiated patient screening. We expect to enroll approximately 25 patients that will be inpatient for 10 days. The primary endpoint of the trial is the effect of escalating doses of Hadoobio on respiratory function as measured by minute ventilation. Secondary End Point measures of additional respiratory functions are also included.
Speaker Change: The protocol has been approved in both the U.S. and the U.K., and the study has initiated patient screening.
Speaker Change: We expect to enroll approximately 25 patients that will be inpatient for 10 days.
Speaker Change: The primary endpoint of the trial is the effect of escalating doses of Haduvio on respiratory function as measured by minute ventilation.
Speaker Change: Secondary endpoint measures of additional respiratory functions are also included.
Jennifer Good: As you can see, these studies have progressed nicely, and data from these trials will be important to inform the development path forward for Hadubio in chronic cough conditions. I want to thank our team who have worked hard to keep enrollment on plan. We look forward to completing these clinical trials and reporting out the data beginning in the fourth quarter of this year. I will now turn it over to Lisa to review our financial results, then we will open it up for any questions you may have. Thank you.
Speaker Change: As you can see, these studies have progressed nicely, and data from these trials will be important to inform the development path forward for Hadubio in chronic cough conditions.
Speaker Change: I want to thank our team who have worked hard to keep the enrollment on plan.
Speaker Change: We look forward to completing these clinical trials and reporting out the data beginning in the fourth quarter of this year. I will now turn it over to Lisa to review our financial results, then we will open it up for any questions you may have.
Lisa Delfini: Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three months ended June 30, 2024, can be found in our press release issued ahead of this call and in our 10Q, which was filed with the SEC today after the market close. For the second quarter of 2024, we reported a net loss of $12.4 million compared to a net loss of $7.1 million for the same quarter of 2023. R&D expenses were $10 million during the second quarter of 2024 compared to $5.8 million in the same quarter of 2023, which reflects the strong clinical activity across all four of our tribes.
Lisa: Thank you Jennifer and good afternoon everyone. The full financial results for the three months and did June 30th, 2024 can be found in our press release issued ahead of this call and our 10Q which was filed with the SEC today after the market closed.
Lisa: For the second quarter of 2024, we reported a net loss of $12.4 million compared to a net loss of $7.1 million for the same quarter in 2023.
Speaker Change: R&D expenses were $10 million during the second quarter of 2024 compared to $5.8 million in the same quarter in 2023, which reflects the strong clinical activity across all four of our trials.
Lisa Delfini: DNA expenses were 3.3 million during the second quarter of 2024 compared to 2.5 million in the same period of 2023, primarily due to increases in personnel and related expenses, market research costs, and information technology services. As of June 30th, 2024, our cash, cash equivalents, and marketable securities totaled 69.5 million, compared to 83 million as of December 31st, 2023. During the quarter, we issued approximately 1.5 million shares from our ATM, which was purchased by a single buyer.
Speaker Change: G&A expenses were $3.3 million during the second quarter of 2024 compared to $2.5 million in the same period of 2023, primarily due to increases in personnel and related expenses, market research costs, and information technology services.
Speaker Change: As of June 30, 2024, our cash, cash equivalents, and marketable securities totaled $69.5 million compared to $83 million as of December 31, 2023. During the quarter, we issued approximately 1.5 million shares from our ATM, which was purchased by a single buyer.
Lisa Delfini: This cash inflow strengthens our runway, and we continue to expect that our cash burn, excluding the proceeds from the share issuance, will average $9 to $12 million per quarter in 2024, and we will have cash runway into 2026. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.
Speaker Change: This cash inflow strengthens our runway post-data readouts on our current clinical trials.
Speaker Change: We continue to expect that our cash burn excluding the proceeds from the share issuance will average 9 to 12 million per quarter in 2024 and we will have cash runaway into 2020-6
Speaker Change: This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.
Operator: We will now begin the question and answer session. To ask a question, you may press star then one on your touchstone phone. If you're using a speaker phone, please raise your hands before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. The first question comes from Annabel Samimy from Stiefel. Please go ahead.
Speaker Change: We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.
Speaker Change: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.
Speaker Change: The first question comes from Annabelle Samimi from Stiefle. Please go ahead.
Jayeth: Hi, this is Jayeth. I'm calling in on behalf of Annabel. Congratulations on the progress this quarter.
Jayeth: I had two questions. The first is related to reverberate chronic cough, and you guys are designing a child. Do they choose different powers and assumptions for the different severity groups being studied, or are they powers of the same treatment effect? And the second question is related to the Human Abuse Potential Study. Can you be confirmed that Nathanael Gershell is not a scheduled drug while the terminal is scheduled for, and that's the case? Is there any reason that you would expect... Any, would there be any reading to expect? that there would be a dose response to likability for the ER formulation? Has there been any indication from the FDA that there was a plan to potentially reschedule an outpatient ER visit? Thank you.
Speaker Change: Hi, this is a giant. I'm calling in Granabel. Congrats on the progress this quarter. I had two questions.
Speaker Change: First is related to reverberate chronic cough and you guys are designing a child on the huge different power in the assumptions for the different security groups being studied or are they parsed at the same treatment effect?
Speaker Change: and then second question is related to the human abuse potential study.
Speaker Change: Can you be confirmed that now the film is not a scheduled drug while the terminal is scheduled for, and that's the case.
Speaker Change: is there any reason that you would expect?
Speaker Change: Would there be any reason to expect that there would be a dose response to likability for the ER formulation? Has there been any indication from the FDA that there was a plan to potentially reschedule LB within ER? Thank you. Thank you.
Speaker Change: Yeah, thank you, Adam. I'm going to let David answer the powering assumptions for each arm, and then I'll take on the half question. Yeah, no, thank you for the question. So, as you know, the primary endpoint in River is the total population's N of 60.
David Clark: Yeah, and thank you for the question. So as you know, the primary endpoint in River is the total population of 60. So that's the primary analysis, but you really requested what you're asking about is the subgroup analyses. We made the same assumptions for the effect size in the... and then for the human abuse potential.
Speaker Change: Thank you.
David Clark: and then for the human abuse potential analysis atom. I mean, now, these things have been around for decades.
Speaker Change: Thank you.
Speaker Change: And then for the human abuse potential...
Adam: analysis, Adam. I mean, now buprenorphine's been around for decades. It's been unscheduled by the DEA and it gets looked at regularly and they continue to unschedule the drug. We also have a lot of information on it, you know, all the preclinical work was done, we have our whole clinical database, etc.
Speaker Change: We feel, based on what we know, the drug should remain unscheduled. There is sort of this last piece to bring it up to current standards, the Human Abuse Potential Study. You know, I guess we'll run the study, we'll see the data, it'll be part of the analysis. They look at sort of eight different factors, of which that's one. But I would just sort of bring everyone back to, you know, there's two pieces of the mechanism in our drug, immune antagonists, none of which are scheduled, and kappa agonists, none of which are scheduled. So it seems a little bit unusual. Butorphanol, just to draw that comparison, is a weak mu-agonist kappa agonist. We're a mu-antagonist kappa agonist. So I don't want to say there's no scenario where that happens, but we're feeling pretty good about our drug
Lisa Delfini: Lisa Delfini
Speaker Change: All right, thank you so much.
Operator: The next question comes from Thomas Smith from Lyrinc Partners. Please go ahead.
Lisa Delfini: Thank you, Adam.
Lisa Delfini: The next question comes from Thomas Smith from Lyrinc Partners. Please go ahead.
Thomas Smith: Hey guys, good afternoon. Thanks for taking the questions and congrats on the progress. Just on the respiratory physiology study, I was wondering if you could comment on your expectations.
Thomas Smith: Hey guys, good afternoon. Thanks for taking the questions and congrats on the progress.
Thomas Smith: Just on the respiratory physiology study, I was wondering if you could comment on your expectations
Thomas Smith: on enrollment in terms of patient disease severity that you're enrolling into the study and then also just comment on the doses that you'll be evaluating in that study and how that compares to what you're looking at in the IPF and RCC studies.
Speaker Change: on enrollment in terms of patient disease severity that you're enrolling into the study. And then also just comment on the doses that you'll be evaluating in that study and how that compares to what you're looking at in the IPF and RCC studies.
David Clark: Sure, I'm going to let David take that.
David Clark: Thank you very much, and thank you for the question. So the doses we're studying are the same that we have in both River and Coral. We're studying up to 108 milligrams BID in that inpatient study. And, sorry, the first part of your question was...
Lisa Delfini: Sure, I'm gonna let David take that. Thank you very much and thank you for the question.
David: So the doses we're studying are the same that we have in both River and Coral. We're studying up to 108 milligrams B.I.D.
David: in that inpatient study and, sorry, the first part of your question was... The gene severity, how severe. So we start the study, in essence, in the same population in which we're studying in coral, so the IPF diagnosis.
David Clark: The gene severity, how severe? So we start the study, in essence, in the same population which we're studying in Coral. So the IPF diagnosis and, in essence, the same population. And then, once we have data from that initial group, we would expand the population, as we've disclosed previously, to include sleep disordered breathing subtypes. So that'll be added to the study and all varieties of sleep disordered breathing in that... study so that we can address the primary question, which is for phase three. We would like to include a broad range of IPF patients and phase three so we can address that question.
David: and in essence the same population and then once we have data from that initial group we would expand the population as we've disclosed previously to include sleep disorder breathing subtypes.
David: So that'll be added on to the study and including all varieties of sleep disorder breathing in that in that
David: Study, so that we can address the primary question, which is for phase three. We would like to include a broad range of IPF patients in phase three, so we can address that question.
Thomas Smith: Got it. That's helpful. And then just, um, look at how to follow up on River. Wondering if you could just elaborate on the, uh, enrollment balance between the moderate and severe patients that you're seeing, everything more moderate or severe, and are there any other basic characteristics that you have visibility into that, um, maybe differ from your initial expectations or some of the other contemporary face-to-face RCC studies.
Speaker Change: Got it. That's helpful. And then just, if I could ask a follow-up on River.
Speaker Change: is wondering if you could just elaborate on the enrollment balance between the moderate and severe patients that you're seeing, or we're seeing more moderate or severe. Are there any other baseline characteristics that you have visibility into that?
Speaker Change: Maybe differ from your initial expectations or some of the other contemporary phase two RCC studies.
Jennifer Good: Yeah, so we don't comment, Tom, on all the sort of specifics within the trial midstream because things go back and forth. I would say, you know, this is, there's sort of a bit of an imbalance, but that's gone both ways. You know, at one point, one arm's a little further ahead than the other.
Speaker Change: Yeah, so we don't comment, Tom, on all the sort of specifics within the trial midstream because things go back and forth. I would say, you know, this is, there's sort of a bit of an imbalance, but that's gone both ways, you know, at one point one arm's a little further ahead than the other. So, we'll sort of lay all that out by subgroup when we get to the end. I would say as far as baseline characteristics, I can tell you when Meg came in, she went through sort of all the subjects enrolled and sort of, you know, all their medical information. And David, you can comment as well, and felt it looked good, you know, good diagnoses, nothing unusual based on what she saw. Absolutely right. I mean, and which is what we expect.
Jennifer Good: So we'll sort of lay all that out by subgroup when we get to the end. But as far as baseline characteristics are concerned, I can tell you when Meg came in, she went through all the subjects enrolled and, you know, all their medical information, and David, you can comment as well, and felt it looked good. You know, good diagnoses, nothing unusual based on what she saw. Absolutely.
David Clark: Absolutely, right. I mean, and that's what we expected. We've, you know, this one of the advantages of the smaller face-to-face studies; you can go to really, very super expert centers for your trial. And so that's what we expected, and that's what happened.
Lisa Delfini: Lisa Delfini
Thomas Smith: Thank you, Tom. I got a question. That's helpful. Thanks for taking the questions and looking forward to the Q4 update.
Lisa Delfini: Thank you, Tom, for the questions. Got it. That's helpful. Yeah, thanks for taking the questions and looking forward to the Q4 updates.
Operator: The next question comes from Leland Gershell from Oppenheimer. Please go ahead.
Lisa Delfini: All right
Lisa Delfini: The next question comes from Leland Gershell from Oppenheimer. Please go ahead.
Leland Gershell: Take good afternoon. Thanks for taking our questions. Just want to ask, you know, as you think about the evolution of the development programs and we're coming up on the RCC top-line data, and as you continue developing a dubio in an IPF kind of cross, you know, would the outcome of the RCC trial impact upon your plans? In IPF, in other words, would you love to prioritize a new view in RCC with that alter, kind of the way you put on the IPF opportunities. It's wondering how you think about those two side-by-side, should, you know, RCC print out a strong data set. Thank you. Yes.
Leland Gershell: Hey, good afternoon. Thanks for taking our questions. I just want to ask, you know, as you think about the evolution of the development programs, and we're coming up on the RCC top-line data,
Leland Gershell: And as you continue developing Hadoopio in IPF Kronikov, would the outcome of the RCC trial impact upon your plans?
Speaker Change: In IPF, in other words, would you look to prioritize Aduvio and RCC? Would that alter kind of the weight you put on the IPF opportunity? Just wondering how you think about those two side by side should, you know, RCC print out a strong dataset. Thank you.
Jennifer Good: Yeah, it's a good question, Leland. We talk about it a lot as a team and as a board. There's a big commitment inside Trevi to that IPF is our lead indication. You know, severe unmet need, not a lot of options for those patients, cough is a big problem. Also, as I laid out in my comments, we believe that cough is potentially contributing to the underlying disease. And so, how we might sort of look at some of those endpoints in an exploratory way.
Speaker Change: Yeah, it's a good question Leland. We talk about it a lot as a team and a board. There's a big commitment inside Trevi that IPF is our lead indication. You know, severe unmet need, not a lot of options for those patients, cough is a big problem. We also, as I laid out in my comments, we believe that cough is potentially contributing to the underlying disease. And so how we might sort of look at some of those endpoints in an exploratory way.
Speaker Change: RCC is interesting because there is unmet need there and how that eventually merges with IPF is sort of, you know, a question we'll have to wrestle with. I think as Trevi, we would look to probably pick up sort of the most, assuming the P2X3 Camlipixin gets approved, we would probably look to be third line therapy behind that for the failures because we'd want to maintain the pricing we have in IPF. We think today that's probably the optimal way to maximize the value of the drug. Now in somebody else's hands that's got a bigger sales force, that may not be the case.
Speaker Change: I would think about this, assuming the data supports it, that Trevi is going to be leading with its IPF program and studying RCC with an eye towards picking up the most severe coughers that aren't getting relief anywhere else. And that could be, by the way, in this moderate cough count, if they're not able to be treated.
Speaker Change: That's we've done some modeling this summer and I think that's how we believe we could best optimize it.
Leland Gershell: Great, thanks very much for the cover.
Speaker Change: Greetings and I'm much for the other talent.
Operator: The next question comes from Mayank Mamtani from B Riley Securities. Please go ahead.
Lisa Delfini: Yeah, thank you, Lisa.
Lisa Delfini: The next question comes from Mayank Mamtani from B. Riley Securities. Please go ahead.
Mayank Mamtani: Good afternoon, team. Thanks for taking our questions and congratulations on the progress. On the Phase IIa river protocol, could you just remind us how that differs from the Phase IIa canal that you previously executed on very successfully? And then I have a quick follow-up.
Mayank Mamtani: Good afternoon to you and thanks for taking a question and congrats on the progress. On the face-to-a river protocol, could you please remind us how that before is from the face-to-a canal that you previously executed on very successfully. May I have a quick follow-up?
David Clark: Thank you so much for the question. The design, as you know, is in essence the same. The only difference we made was based on the early efficacy signal that we saw in the canal design where we went up to 162 milligrams BID, we capped the dose at 108 BID. So the dose we reduced compared to canal, and we increased the washout period up to three weeks. There's another minor difference as well.
Speaker Change: Thank you so much for the question, so the design, as you know, is in essence the same. The only difference we made is based on the early efficacy signal that we saw in the canal design, where we went up to 162 milligrams BID.
Lisa Delfini: We capped the dose at 108 BID, so the dose we reduced compared to canal, and we increased the washout period up to three weeks.
David Clark: Canal was run when COVID was very active, and we could only get the objective cough endpoint at baseline and week three. Here we've gone back to when we were able to get weekly objective cough data, which was always the aim of Canal, but COVID got in the way.
Lisa Delfini: is another minor difference as well.
Speaker Change: can now run when COVID was very active and we could only get the objectives coffin point at baseline and week three here we've gone back to the more we were able to get weekly objective cost data which was always the aim in canal but COVID got in the way
Mayank Mamtani: Very helpful, thank you. And then on PROs, which we all know is an important regulatory topic also, could you just remind us what you're looking for in CORO, obviously, and then is River also going to give us some more information on some of these PROs? And then after that, I have one more question.
Speaker Change: Very helpful. Thank you. And then on the PROs, which we all know is an important regulatory topic also, could you just remind us what you're looking for in coral, obviously, and then is river also?
Speaker Change: are going to give us some more information on some of these PROs and then I have one more question after that.
David Clark: Yeah, so we increased the range of PROs, and I'll start with the Coral study first, compared to the canal study. So in Coral, we basically have the opportunity to profile both with coffee, we can see score. That's we're using the exact, which would be the same endpoint we used and face to aim, can now.
David Clark: It's been unscheduled by the DEA, and it gets looked at regularly, and they continue to unschedule the drug. We also have a lot of information on it. You know, all the pre-clinical work was done. We have our whole clinical database, et cetera. So we feel, based on what we know, the drug should remain unscheduled.
Speaker Change: Yeah
Speaker Change: Yeah, so we increase the range of PROs, and I'll start with the CORAL study first, compared to the CANAL study. So in CORAL, we basically have the opportunity to profile both with cough frequency score, that's we're using the EXACT, which was the same endpoint we used in Phase 2a in CANAL.
Speaker Change: but we've also expanded quite broadly living with IPF. A lot of PROs which allow you to get a good feel for the overall clinical characteristics and improvements, including functional improvements that you get.
Jennifer Good: Yeah, thank you Adam. I'm going to let David answer the powering assumptions for each arm, and then I'll take on the half question. Yeah, no.
Speaker Change: So we've got a broad range of PROs, so less the cough questionnaire you would expect. Living with IPF is a very good instrument. And then standard anchor measurements, patient's global impression of severity and change in cough and IPF. Those are the sorts of measures. Those are some of the most important.
Speaker Change: PROs we added there, and we took a similar approach, frankly, even in the small river study. So there, the important secondary endpoints of PROs would be cough frequency again.
David Clark: Living the list of cough questions there, and cough severity, we're using the VAS measurement because that's used in the majority of RCC programs, so it's a good comparison compared to other programs. We may at some stage switch to the cough severity in our rest measurement because, regulatory wise, that'll probably be a better endpoint for approvals, but that's a relatively small detail. And then again, good anchor with patient global impression of severity and change in cough in the river study as well.
Speaker Change: living the Lester Koff questionnaire.
Speaker Change: and Koff Severity. We're using the VAS measurement because that's used in the majority of RCC programs, so it's a good comp.
Speaker Change: compared to other programs. We may at some stage switch to the cough severity NRS measurement because regulatory-wise that'll probably be a better endpoint for approvals but that's a relatively small detail. So
Speaker Change: And then again, good anchor with patient global impression of severity and change in cough in the river study as well.
Jennifer Good: Very helpful, thank you. And then lastly, on your earlier comment, Jennifer, on the focus on the severe cough cohort or maybe refractory to P2X3, is that a more recent development or is that something that you're just gonna be data-dependent on what you learned from RCC? And I just ask that because your final dose ranging work could give you a different dose in those two different indications. So I was just curious how tied you are to the idea of pegging yourself to the idea of chronic cough indication.
Speaker Change: Very helpful. Thank you. And then, lastly, on your earlier comment, Jennifer, on the focus on severe tough cohort or maybe refractory
Speaker Change: to P2X3. Is that a more recent development or is that something that you're just going to be data dependent on what you learn from RCC?
Speaker Change: And I just ask that because your final dose ranging work could give you a different dose in those two different indications. So I was just curious how tied you are to the idea of pegging yourself to the idea of chronic cross-indication.
Jennifer Good: It's a good question, Mayank. Like I said, it's something we debate a lot. I would say it's come out of a bit of work this summer, and you are right, this is all going to be data-driven. Obviously, these are two big indications; there is a lot of unmet need in both. So, lots of opportunity here. I think what we've been wrestling with a bit as a small company, you know, IPF is very, we can take that all the way through approval, and if we had to commercialize it, it's a very specialty sales force. So we feel really comfortable with that model.
Speaker Change: It's a good question, Mayank. Like I said, it's something we debate a lot. I would say it's been, it's come out of a bit of work this summer, and you are right, this is all going to be data driven. So obviously, these are two big indications, a lot of unmet need in both. So lots of opportunity here. I think what we've been wrestling with a bit as a small company, you know, IPF is very, we can take that all the way through approval. And if we had to commercialize it, it's a very specialty sales force. So we feel really comfortable with that model. RCC starts to open sort of that can of worms a lot broader. So the work that our colleague has done a lot this summer is trying to figure out how you could maintain the premium pricing that we think we can get an IPF into an RCC population.
Jennifer Good: RCC starts to open sort of that can of worms a lot wider. So, the work that our colleague has done a lot this summer is trying to figure out how you could maintain the premium pricing that we think we can get in IPF in an RCC population, but those decisions are by no means final. I would just say that I'm probably out of some research this summer and thinking about how to optimize it without cannibalizing IPF.
Speaker Change: Appulation, but...
Speaker Change: Those decisions are by no means final. I would just say that's probably out of some research this summer and thinking about how to optimize it without cannibalizing IPF. That's our current thinking. But on the other hand, the RCC market's big enough, and that's what I say, in somebody else's hands that's already got an existing sales force, you could see them launch much more broadly because they don't have the cost sort of associated with building that.
Jennifer Good: That's our current thinking. But on the other hand, the RCC market's big enough, and that's what I say. In somebody else's hands, it's already got an existing sales force. You could see them launch much more broadly because they don't have the cost sort of associated with building that.
Jennifer Good: So, you're right, it'll be data-dependent. Really, not something we have to decide for a while. I mean, we'll continue on. We'll run the next study. But at some point, somebody's got to wrestle with that question.
Speaker Change: So, you're right, it'll be data dependent, really not something we have to decide for a while. I mean, we'll continue on, we'll run the next study, but at some point somebody's got to wrestle with that question.
Mayank Mamtani: Yep, it makes an order sent and end good to be ahead of that. Thanks again for taking your question; I then look forward to it.
Speaker Change: Yep, makes a lot of sense and good to be ahead of that. Thanks again for taking our questions and look forward to the 4Q update.
Operator: and the next question comes from Brandon folks from Roman in Rancho. Please go ahead.
Mayank Mamtani: Thank you, Mayank.
Speaker Change: The next question comes from Brandon Folks from Rodman and Renshaw. Please go ahead.
Brandon Folks: Hi, thanks for taking my questions and congratulations on all the progress. Maybe just for us on the update or read out.
Speaker Change: you
Brandon Folks: In terms of a positive outcome, is it really as long as we don't see a dose-dependent likability that that's a positive outcome for you and strengthens your discussions with the agency? So that even if we see high likability in one of the groups...
Speaker Change: I'm sure we'll see some likeability, but as long as it's not those dependent, should we interpret that as a positive and strengthening your discussion with the agency?
Jennifer Good: Brandon, it's a good question. Like all data, sort of, the good stuff to what you see, I would say, you know, there's a published paper Carer did with their capa agonistware. They showed separation from placebo, but they were less likeable than their comparator pentazane. They only had one dose, so the dose response question wasn't there. That drug was left unscheduled.
Brandon Folks: So, Brandon, it's a good question. Like all data, it's sort of the gestalt of what you see. I would say, you know, there's a published paper CARA did with their Kappa agonist where they showed separation from placebo, but they were less likable than their comparator pentazazine. They only had one dose, so the dose response question wasn't there. That drug was left unscheduled. So, I think at a baseline on data, you know, we will likely separate from placebo, but hopefully be less likable or similar to our comparator. I think that puts us in a strong situation. Now, having said that, you are right that what the FDA really has concerns that there's a little bit of signals and likability that you don't see the dose dependence because you don't want to see somebody.
Speaker Change: Like it a bit and then you take sort of three acts of dose and they like it three times more.
Speaker Change: It's a bit of all of that combined, so it's certainly something we'll look at, but our expectation is this drug should not be all that likable. I mean, you've looked at our adverse events profile, and we just don't see that.
Speaker Change: So when we get all the data, we'll lay it out for the street and also have an expert to help sort of interpret what we've seen and our own conclusions around it.
Brandon Folks: Right, very helpful, and then maybe just shifting gears into the respiratory study. Yeah, anyway, to characterize what you think the hurdle rate is to include sleep disorder patients going forward, or is it also a case of generating the data and then having a conversation with the agency in terms of whether it's enough to get these sleep disorder patients, or do you think there's a finite hurdle here at the agency one?
Speaker Change: Yeah, anyway, to characterize what you think.
Speaker Change: The hurdle right here is to...
Speaker Change: include sleep disorder patients going forward? Or is it also a case of generate the data and then have the conversation with the agency in terms of whether it's enough to get these sleep disorder patients? Or do you think there's a finite hurdle here that the agency wants to see?
David Clark: Regarding the respiratory physiology study, I think there are well-established endpoints and markers of what is a clinically relevant change in ventilation, which, for example, which is the primary endpoint that we can utilize. So actually, we think the signal of the study will be relatively interpretable ourselves when we get this because, in clinical practice, there is fairly clear guidance as to what is a clinically relevant change in all the endpoints we're looking at.
Speaker Change: With regards to the Respiratory Physiology Study, I think there are well-established...
Speaker Change: endpoints and markers of what is a clinically relevant
Speaker Change: Change in Ventilation, which, for example, which is the primary endpoint, which we can utilize, so actually we think the signal of the study will be relatively interpretable ourselves when we get this, because in a clinical practice.
Speaker Change: there are fairly clear guidance as to what is a clinically relevant change in all the endpoints we're looking at. So we believe that the results of the study will be interpretable by ourselves. I don't, it's definitely not our thinking that we have to.
David Clark: So we believe that the results of the study will be interpretable by ourselves. It's definitely not our thinking that we have to, it's mandatory that we have to go back to the FDA and have some discussion. As part of an end of phase two meeting, we'll have this data set, but we think it'll be more straightforward than now. Here's a detailed discussion about the relevance of all these findings.
Speaker Change: It's mandatory that we have to go back to the FDA and have some discussion, you know. As part of, you know, as part of an end-of-phase-2 meeting, we'll have this data set.
Speaker Change: But we think it'll be more straightforward and now here's a detailed discussion about the relevance of all these findings.
Brandon Folks: Thanks for your help, and then maybe last, just following up on a few of the earlier comments, just on the river imbalance between the two arms. You talked about how this fluctuated throughout the study. Is this just the normal part of the fluctuation and of that cycle, or has one patient group become a little bit more competitive to enroll going forward? I know you're not giving any color on which patient group, but is there sort of a fundamental competition for one of these patient groups, or is it just a normal fluctuation? Thank you
Speaker Change: Thanks that's very helpful and then maybe lastly just following up on a few of the earlier comments just on the river imbalance between the two arms.
Speaker Change: and you talked about sort of how this is fluctuated throughout the study.
Speaker Change: Is this just a normal part?
Speaker Change: are the fluctuation and of that cycle or has one patient group become a little bit more competitive to enroll.
Speaker Change: going forward. I know you're not giving color on which patient group, but you know, is there sort of a fundamental competition for one of these patient groups or is it just normal fluctuation? Thank you
David Clark: So we always expected, thank you for the question, we always expected, you know, you're always going to get one group that recruits a little bit faster than the others when you, you know, but we didn't, weren't predicting which one, frankly. The difference here that Jennifer was speaking to was a little bit larger than we expected.
Speaker Change: So, we always expected, thank you for the question.
Speaker Change: We always expected, you know, you're always going to get one group's going to recruit a little bit faster than the others when you, you know, but we expect, you know, we didn't, weren't predicting which one, frankly. The difference here that Jennifer was speaking to is the difference was a little bit larger than we expected. And that's why, as we've always explained,
David Clark: And that's why, as we've always explained, we think approximately 30 subjects per group in these two subgroups, the 10 to 19 and the greater than 20 patients, will allow us to detect, you know, a clinically meaningful effect size. We've got more than 80% power in both of these subgroups with about approximately 30 subjects to detect a mid 30% effect size on top of placebo. And for that reason, we think it's important, too, to stick with that stated aim, and that's what Jennifer was speaking about. So the difference was the imbalance was a little bit larger than we were expecting when we started the study, but we always knew there would be one group that recruited quicker.
Speaker Change: We think approximately 30 subjects per group in these two subgroups the 10 to 19 and the greater than 20 patients
Speaker Change: will allow us to detect, you know, a clinically meaningful effect size. We've got more than 80% power in both of these subgroups with about approximately 30 subjects to detect a mid 30% effect size on top of placebo. And for that reason, we think it's important to
Speaker Change: stick with that stated aim, and that's what Jennifer was speaking to. So the difference was, the imbalance was a little bit larger than we were expecting when we started the study, but we always knew there'd be one group that would recruit quicker.
Jennifer Good: and It's a difference of a month or two of recruiting. So, you know, we'll just see how it comes together. This issue could go away. I'm just reminding people of the protocol and that that could come up at the end of the study.
Speaker Change: And it's a difference of a month or two of recruiting. So, you know, we'll just see how it comes together. This issue could go away. I'm just reminding people of the protocol and that that could come up at the end of the study.
Brandon Folks: Thank you very much, very helpful as always, and congrats on the progress. Thank you.
Speaker Change: Thank you very much, very helpful, and congrats on the progress.
Operator: It's nice to have you following us.
Speaker Change: Thank you Brandon. Nice to have you following us.
John Giunco: The next question comes from John Giunco from Newtonman Company. Please go ahead.
Speaker Change: The next question comes from John Gianco from Needham & Company. Please go ahead.
John Giunco: Hi, this is John on behalf of Serge today. Thanks for taking our questions. First, regarding the IP for now using ER, can you provide an overview of the current patent coverage and if any additional applications are outstanding at this time, and whether the existing method of use IP applies equally to both IPF and RCC?
John Gianco: Hi, this is John on for Serge today. Thanks for taking our questions.
John Gianco: First of all, I'm going to start with the IP for NWFNER. Can you provide an overview of the current patent coverage and if any additional applications are outstanding at this time? And whether the existing method of the VU-SIP applies equally to both IPF and RCC.
Speaker Change: Yeah, good question, John . Thank you. So, we have issued a method of treatment patents. We have a set of formulation patents that protect the product till roughly 2030, but we have issued method of treatment patents, which is really the core of the protection, that are issued through 2039 for IPF costs. We do have worldwide rights and patents that we've prosecuted around that. There are some additional applications being prosecuted as well concerning other clinical work we've done around the label, things like dosing in the elderly or hepatically impaired, renally impaired, probably get some IP maybe out of our human abuse potential study. So, those kinds of patents that are being prosecuted now would actually extend this.
Speaker Change: out to one group's 241 and one group's 243.
Speaker Change: But I think of this sort of the core of the patent coverage through this method of treatment 2039 As for refractory chronic cough that broadly follows under the same umbrella We're waiting for our data out of this river study and then we'll prosecute the actual claims around the data We saw file them as track one claims and those should be issued as well We wrote the overall invention with it in mind that we would be looking at IPF
Speaker Change: Other interstitial lung diseases and refractory chronic cough and we pull from that application when we get actual data to get the claims issued.
Jennifer Good: Great, sounds good. And just a quick follow-up, if you could discuss the current patient population with regard to RCC in terms of how many are diagnosed and how many are currently seeking treatment, just to provide a little granularity on that.
Speaker Change: Great, sounds good. And just a quick follow-up, if you could discuss the current patient population with regard to RCC in terms of how many are diagnosed and how many are currently seeking treatment, just to provide a little granularity on that. Thanks.
Jennifer Good: Yes, a good question. We have some of this in our corporate deck, and I don't have my commercial colleague on it.
Speaker Change: Yes, good question. We have some of this in our corporate deck and I don't have my commercial colleague on. We believe there's about 2 to 3 million treatable patients in the U.S. It's a big indication. I think there's roughly 7 million patients diagnosed in the U.S., but when you sort of work that down of people who are looking for treatment and not getting proper care, sort of it brings its way down to about 2 to 3 million patients.
Speaker Change: But if you want to, John , we can follow up on that, and I can have Farrell join the call, and we can give you a better walk-down.
John Giunco: Great, yeah, that sounds good, and congratulations again on the progress. Thank you for the fun!
Jennifer Good: Thank you for the questions.
John Gianco: Great, yeah, that sounds good, and congrats again on the progress.
Operator: The next question comes from Devon Johnna, from Chattergy, from James Trading. Please go ahead.
Speaker Change: Thank you for the questions.
Speaker Change: The next question comes from Devin Jonna from Chatterjee from Jones Trading. Please go ahead.
Speaker Change: Hi, thanks for taking my question. Are you able to hear me? Yes, yes. Okay, I would kind of curious like how long of a delayed view anticipate to the RTC's readout because of this imbalance. And I have a follow up question.
Jennifer Good: Bye-bye.
Jennifer Good: I mean, sitting here today, I don't expect any delay. We've confirmed our guidance for the fourth quarter of this year. We are at 80% enrolled. So I just bring up the issue because if we get to the end and want to hold the trial open for, I mean, we're not going to hold it open for more than a month or two at the most to get these arms and balance, and it may not even be required. So at this point, I don't expect any delay. I'm just pointing out that that wasn't a part of our protocol. We really wanted to try to execute on to get the information.
Speaker Change: I don't know. I mean, sitting here today, I don't expect any delay. You know, we've confirmed, reaffirmed our guidance for the fourth quarter of this year. We are we're 80 percent enrolled. So I just only bring up the issue because if we get to the end and want to hold the trial open for.
Speaker Change: I mean, we're not going to hold it open for more than a month or two at the most to get these arms in balance and it may not even be required. So at this point I don't expect any delay. I'm just pointing out that that wasn't a part of our protocol we really wanted to try to execute on to get the information.
Jennifer Good: And maybe one other question, as you mentioned that, you know, it's, I mean, in case you decide to leave the government and execute the RTT program on your own, like you could be considering, like, in third line, how big do you think the opportunity size is there, how many, like, what's the number of patients?
Jennifer Good: [inaudible]
Jennifer Good: Yes, that's very helpful. Thank you. And maybe one other question as you mentioned that you know, it's I mean in case you decide to Lead the I mean, you know and execute like the RCC program on your own Like you could be considering Like, you know in third line, how big do you think the opportunity size is there? How How many like what's the number of patients?
Jennifer Good: Yes, so we have not shared all of that. We're doing a lot of work this summer. It's a big patient opportunity. I mean, you know, there are a lot of P2X trees. I know you followed that space, Dev and Donna, you know, they don't work in sort of 30 to 40 percent of the patients. Some of the patients they work on have very severe coughs, and even then, with the reduction in cough, it's not completely reduced.
Jennifer Good: Yeah, so we have not shared all of that. We're doing a lot of work this summer. It's a big patient opportunity. I mean, you know, with a lot of the P2X3s, I know you followed that space, Deb and Donna, you know, they don't work in sort of 30 to 40% of the patients. Some of the patients they work in have very severe cough, and even then, with the reduction in cough, it's not completely reduced.
Brandon Folks: Hi, thanks, segment questions, and congratulations on all the progress. Maybe just firstly, on the half day to read out loud, eat it. In terms of a positive outcome, is it really as long as we don't see a dose-dependent likability that that's a positive outcome for you and strengthens your discussions with the agency? So even if we see high likability in one of the groups, I'm sure we'll see some likability, but as long as it's not dose-dependent, should we interpret that as positive and strengthen your discussions with the agency
Speaker Change: So, there's a pretty big opportunity here for this group with really not a lot of options. So, we are finishing up our market research and at some point we'll share sort of our views on that and how that walks down, but we view that as a very significant market opportunity, particularly in light of the fact there's very little, there's not a lot of competitors left in the space.
Devon Johnna: Thanks a lot. Yeah, thank you.
Devon Johnna: Thanks a lot. Yeah, thank you.
Jennifer Good: This concludes our question and answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.
Jennifer Good: This concludes a question and answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.
Jennifer Good: Thank you for joining us. We are expecting a steady flow of data in the upcoming months with regard to our clinical trials data, and we look forward to sharing this with you. We will be participating in several investor conferences over the next couple of months, as listed in our press release, and hopefully, we will see some of you there. Thank you for joining us on the call, and we're available afterwards for any questions you may have.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Operator: Thank you for joining us. We are expecting steady news flow of data in the upcoming months with regards to our clinical trials data, and we look forward to sharing this with you. We will be participating in several investor conferences over the next couple of months as listed in our press release, and hopefully we will see some of you there. Thank you for joining the call, and we're available afterwards for any questions you may have.
Operator: The conference is now concluded, thank you for attending today's presentation. You may now disconnect.
Jennifer Good: Yeah, a good question, John. Thank you.
Devon Johnna: Hi, thanks for taking my question. Are you able to hear me? Yes. Yes, okay. I was kind of curious, like how long of a delay do you anticipate for the RCC readout because of this imbalance? And I have a follow-up question.
Jennifer Good: The drug is not working in the pre-specified range, and the company should consider stopping it. We will announce the results of this analysis, and we have the information we expect in the fourth quarter of this year. We continue to expect top-line data for the full study in the first half of 2025, subject to the result of the SSRE. We are also conducting two important supportive studies this year, the Human Abuse Potential, or HAP, study, as well as the Respiratory Physiology study. I will give you a quick update on both.
Jennifer Good: So we have issued a method of treatment patterns. We have a set of formulation patterns that protect the product till roughly 2030, but we have issued a method of treatment patterns, which is really the core of the protection that is issued through 2039 for ITF costs. We do have worldwide rights and patterns that we've prosecuted around that. There are some additional applications being prosecuted as well, concerning other clinical work we've done around the label, things like dosing in the elderly or hypothetically impaired, probably gets my P maybe out of our human abuse potential study.
Jennifer Good: We wrote the overall invention with it in mind that we would be looking at IPF's other interstitial lung diseases and refractory chronic cough, and we will pull from that application when we get actual data to get the claims issued.
Jennifer Good: So I think it is based on data. You know, we will likely separate from placebo, but hopefully, the less likeable or similar to our comparator. I think that puts us in a strong situation. Now, having said that, you are right that the FDA really has concerns that there's a little bit of signals and likeability that you don't see the dose dependence, because you don't want to see somebody like it a bit, and then you take sort of of a reaction to the dose, and they like it three times more.
David Clark: But we've also expanded quite broadly, living with IPF, a lot of PROs, which allow you to get a good feel for the overall clinical characteristics and the improvements, including functional improvements that you get. So we've got a broad range of PROs, so let's take off the question areas that you would expect, living with IPF is a very good instrument. And then standard anchor measurements, the patient's global impression of severity and change in cough and IPF, those sorts of measures.
Jennifer Good: We believe there are about two to three million treatable patients in the U.S. It's a big indication. I think there are roughly seven million patients diagnosed in the U.S., but when you sort of work that down to people who are looking for treatment and not getting proper care, it sort of brings it down to about two to three million patients. But if you want to join, we can follow up on that, and I can have Feral join in the call, and we can give you a better walk down.
Jennifer Good: RCC is interesting because there is unmet need there, and how that eventually merges with IPF is sort of, you know, a question we'll have to wrestle with. I think, as Trevi, we would look to pick up sort of the most, assuming the P2X3, Kamala Pixink, is approved. We would probably look to be third-line therapy behind that for the failures because we'd want to maintain the pricing we have in IPF.
Jennifer Good: So there's a pretty big opportunity here for this group with really not a lot of options. So we are finishing up our market research and at some point will share sort of our views on that and how that plays out. But we view that as a very significant market opportunity, particularly in light of the fact there's not a lot of competitors left in the space. Thank you.
David Clark: There is sort of this last piece to bring it up to current standards, the human abuse potential study. You know, I guess we'll run the study. We'll see the data. It'll be part of the analysis. They look at sort of eight different factors, of which that's one. But I would just sort of bring everyone back to, you know, there are two pieces of the mechanism and our drug, a new antagonist, none of what you're scheduled for and capaagunist, none of what you're scheduled.
Jennifer Good: So those kinds of patterns that are being prosecuted now would actually extend this out to one group's 2041 and one group's 2043. But I think of this sort of as the core of the patent coverage through this method of treatment 239. As for refractory chronic cough, that broadly falls under the same umbrella. We're waiting for a date from this river study, and then we'll prosecute the actual claims around the data we saw, file them as track one claims, and those should be issued as well.
David Clark: Those are some of the most important PROs we added there. And we took a similar approach, frankly, even in the small river study. So they are the important secondary employees of PROs that we would be coffee can see again.
Jennifer Good: We think today that's probably the optimal way to maximize the value of the drug. Now, in somebody else's hands, it's got a bigger sales force, so that may not be the case. So, I would think about this, assuming the data supports it, that Trevi is going to be leading with its IPF program and looking at and studying RCC with an eye towards picking up the most severe coffers that aren't getting relief anywhere else.
Jennifer Good: So it's a bit of all of that combined. So certainly, something we will look at, but our expectation is this drug should not be all that popular. I mean, you've looked at our adverse events profile, and we just don't see that. So when we get all the data, we'll lay it out for the street and also have an expert to help sort of interpret what we've seen in our own conclusions around it.
David Clark: So it seems a little bit unusual. Your torpenologist to draw that comparison is a weak new agonist capaagunist, where a new antagonist is. So I don't want to say there's no scenario where that happens, but we're feeling pretty good about our drug and have not sort of seen any issues with that. But, you know, clearly, you have to run the study and see the data, and then we'll submit everything when we get it.
Jennifer Good: And that could be, by the way, in this moderate cough count if they're not able to be treated. But we did some modeling this summer, and I think that's how we believe we could best optimize it.