Good afternoon, and welcome to the Trevi Therapeutics Third Quarter 2026 Financial Results and Corporate Update conference call. At this time, all participants are in listen-only mode. After today's presentation, there will be opportunity to ask questions. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference 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 safe harbor 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 factors, including those discussed in the risk factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings with the SEC. In addition, any forward-looking statements represents 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 companies may elect to update these forward-looking statements at some point in the future, the companies specifically disclaims any obligation to do so, even if views change. I'd like to turn the conference call over to Jennifer Good, Trevi's President and CEO. Please go ahead.
Good afternoon, and thank you for joining us for our third quarter 2026 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer, Farrell Simon, our Chief Commercial Officer, and David Hastings, our Chief Financial Officer. Dave and I will make some initial comments, and then the team is happy to answer any questions you may have. 2026 is a busy year of execution for the company, and the team is heads down on initiating and executing clinical trials in each of our programs. This includes activating sites globally, focusing on ensuring enrollment stays on track, all while staying aligned with the regulatory authorities. It has been fast-paced, but this is the fun part of what we do. Let me provide a brief update on each of our programs. First, our lead program in IPF-related chronic cough.
We have initiated both OCEAN-1 and OCEAN-2 trials. We are now approved by all regulatory authorities in each of the countries in which we are conducting clinical trials, and the clinical team is focused on getting all the sites activated and screening patients. We will give an update once we reach 50% of the patients randomized in each of these trials. The trials are in early stages and progressing, and we continue to believe we are on track with our previously stated guidance for OCEAN-2, the 12-week study reading out in the second half of 2027, and OCEAN-1, the 24-week efficacy endpoint with 52 weeks of safety, reading out in the first half of 2028. In October, we took an important step forward in our non-IPF ILD cough program by aligning with the FDA on the development plan and next study.
The pulmonary division has been very helpful and supportive as we think about how to get the first chronic cough drug approved in the U.S. The discussions have been collaborative and clear. Following this meeting with the FDA, our plan is to conduct a phase II dose-ranging study with approximately 120 non-IPF ILD patients to confirm the optimal dose or doses to take forward into phase III. The protocol is written and will be submitted back to the FDA for any comments. We also have the wheels in motion identifying sites and working with our CRO partner to prepare for study initiation. Recall that these clinical centers will overlap directly with the same sites we are using in our North American IPF phase III program. When we signed a contract and negotiated budgets for our OCEAN trials, we planned for the fact that we likely would conduct an ILD trial.
We are planning to initiate this trial in the first quarter of 2027. We will study two doses of Haduvio for 12 weeks of fixed dosing in patients with interstitial lung disease, excluding patients with IPF. We anticipate top-line data to be available in the first half of 2028. Remember, the ILD opportunity more than doubles the IPF potential, and we continue to hear about the high unmet need in this population from doctors. In parallel to the clinical work, we are looking at prevalence and epi data to help refine our estimates of the commercial opportunity in non-IPF-related chronic cough. Turning now to refractory chronic cough, or RCC, and our late phase IIb trial. With the two competitive drug failures this summer, I have talked more about this program over the past few months than I thought was humanly possible.
Let me try to briefly summarize where things stand in the RCC space and explain the upcoming sample size re-estimation, or SSRE. First, there are no active competitive programs left in RCC, or any of our targeted chronic cough indications for that matter. Peripheral-only mechanisms have not been able to withstand the complexity and heterogeneity of cough triggers. It was always our hypothesis that while the peripheral mechanism plays a role in sensory signaling, the central mechanism is critical in mitigating the hypersensitivity related to cough. Second, I've been asked about the differences in market dynamics between RCC and IPF and non-IPF-related chronic cough. The reality is that RCC is a significant unmet need in which patients' quality of life is deeply affected. We believe that if our drug can offer relief to these patients, we can figure out the commercial dynamics.
We are working on various options around targeting the most refractory patient group, potentially with lower doses, et cetera. In a world where it all starts with the patient, RCC is a severe chronic cough condition with no good treatment options. There have been numerous examples of brands, such as DUPIXENT, successfully navigating payer dynamics in larger follow-on indications. Finally, as you know, drug development has been very challenging in RCC because of the heterogeneity of patients with chronic cough, as well as the placebo effect. We believe we have distinct advantages with our dual central and peripheral mechanism, and the demonstrated evidence that our drug works broadly across cough counts. However, we are mindful that there have been very few positive trials.
So, as we design the phase IIb LAKE study, we built in a sample size re-estimation, or SSRE, to account for variability in the patient population, placebo effect, et cetera. Let's just recap the analysis. Once 50%, or 50 patients, complete the trial, an independent stats team outside of Trevi will look at the unblinded data and confirm powering assumptions at that point in the study. Essentially, we will get one of three answers back with no corresponding data, so as not to unblind the trial. The three potential answers are, one, the trial to date has at least 80% power, and we should continue with the original plan of enrolling 100 patients. Two, the trial is showing a conditional power range of 40%-80%. This means the drug is working, but there is either more variability or less of an effect size than our original assumptions.
We then will upsize accordingly, up to a maximum of 152 patients. It is not all or nothing with the upsize. It is a proportional upsize from four to 52 patients, meant to restore at least 80% conditional power. A little color on what that means. The effect size in this conditional power range represents an effect size of approximately low 20% range to 30%. Just to be clear, effect size is defined as drug effect less placebo. A 20%-30% effect size is clinically meaningful and could have a significant impact in a world where there are no good options. And finally, the third option for the SSRE is futility. The conditional power at the time of analysis for the trial would be below 40% and suggest futility for the fully completed trial.
In light of the fact that the study will likely be close to fully enrolled and there are no competitive programs left, we would plan to finish enrollment based on the original sample size of 100 and look at the data. To wrap up this SSRE discussion, the SSRE design means that a non-futile result is a clinically meaningful benefit in cough reduction, and upsizing the trial slightly is to ensure that clinical meaningfulness is statistically significant at the end of the study. We estimate we will have the results of the SSRE in the early part of the first quarter and have reconfirmed our guidance for full trial results in the second half of 2027.
Finally, last month, a number of chronic cough patient advocacy organizations teamed up to hold an externally led patient-focused drug development, or PFDD, meeting with the FDA to discuss the disease burden of chronic cough. Patients told their stories of the impact on their lives, and their experiences exemplified the burden of chronic cough across IPF, ILDs, and RCC patients. One ILD patient stated, "Cough is the single greatest thief of my quality of life." This meeting represents a meaningful engagement with the FDA in raising the need for effective and safe therapies. The results will be released in 2027 in a Voice of the Patient report. We are pleased by the focus of the FDA on this significant unmet need. In closing, we are focused on executing against our plan of becoming the leader in chronic cough.
With the recent competitive failures in RCC, we are alone in all three of our cough indications and have the potential to be a first-in-class therapy in very big markets. We believe if we are able to execute against our current plan, we can create meaningful value for patients and, in turn, significant value for our shareholders. I will now turn it over to Dave for his remarks, and then we are happy to answer your questions. Dave?
Thanks, Jennifer, and good afternoon, everybody. My remarks today will focus on our most important financial metric, which is our cash position and the runway it provides. We ended the third quarter of 2026 with approximately $299 million in cash equivalents, and marketable securities. Importantly, we are well capitalized to execute on our development plans, as our cash runway extends into 2030. This allows us to fund our clinical trials to key value inflection points, including our lead program in IPF-related chronic cough through potential FDA approval. As Jennifer mentioned, we recently completed a positive FDA meeting where we got clarity on the clinical trial pathway for our non-IPF ILD-related chronic cough program. With that feedback, our current cash runway includes funding that program through top-line data in our upcoming phase II trial.
Additionally, our current cash resources will fully fund our ongoing phase IIb LAKE trial for the treatment of patients with RCC. The planned spending of these cash resources also includes pre-commercial activities, but does not include any expenses related to the commercial launch of Haduvio or a phase III clinical trial in RCC or non-IPF ILD. With that, I believe we are well-positioned to execute our clinical trials with sufficient funding through critical data points. Operator, we can now open the call for questions.
Thank you. We will now conduct a question-answer session. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. At this time, we will pause momentarily to assemble our roster. Our first question comes from the line of Roanna Ruiz of Leerink Partners. Your line is now open.
Great. Hi, everyone. I was curious, can you give me more color on your ILD chronic cough meeting with the FDA? Did you achieve all your goals going in, and are there any trial design features that we should think about for the phase II dose-ranging study that are particularly important for setting up the value proposition in this indication?
Hi, Roanna. This is Jim. Thanks for the question. We had a very positive and very supportive meeting with the FDA. I think the key takeaways are really around the design of the phase II dose-ranging trial, which will look very much like the CORAL study that we did to really launch the IPF program. One difference being that this will be a longer trial that will really support a more fully phase III program. I think the dose-ranging part of this is really to understand in this other ILD population that we have the same parameters for dosing and dose selection. I think we had really nice alignment on what we need to do there, and nothing out of the ordinary. I think just basic, show me the data and show me the doses that are really working in this particular population.
Makes sense. Thinking ahead to a potential phase III program in ILD chronic cough, any ideas on where you might land? Would it be a single phase III, or any insights coming out of your interactions with the FDA?
I think there's another thing that we had some dialogue on. I think because we want to take into account the fact that this is a follow-on to the IPF program. This will be an sNDA regulatory submission pathway. We'll be building on the data that we have from the IPF ILD population to support the non-IPF ILD population in that program going forward. The beauty of our approach here and the alignment we have with the FDA is to take this stepwise to help them understand what's needed here and for us to understand what they're looking for.
The phase II dose-ranging study is really to identify the doses, get experience in this patient population, build that on top of our findings and our observations with the IPF population, and then design the most efficient, hopefully, and I think realistically, one phase III trial that will bring us to support the sNDA for non-IPF ILD.
Sounds good. Thanks a lot.
Thank you. One moment for our next question. Our next question comes from the line of Annabel Samimy of Stifel. Your line is now open.
Hi. Thanks for taking my question. Just to follow on the ILD study, obviously it looks very much like the IPF study. I am wondering if the FDA has asked you to do anything more, or have you baked in any other subgroup analyses with this population, given that it is a little bit maybe more variable than the IPF population? Are you looking to identify different subgroups with your trial, or is it just not possible at this stage?
Hi, Annabel. Jim again. Thanks. It's a great question, and one that we had a really good dialogue with a number of the KOLs in this space, because it is a diverse population. It's more heterogeneous than IPF. IPF is that part of the ILD world that is really a more unified type of population. But when we get into non-IPF, there's really over 100 different conditions that are involved there. But the underlying condition, the fibrotic lung disease, is a common thread among all of these patient groups. We're going to capitalize on the fact that they have this underlying lung condition, a certain amount of fibrosis, as well as the cough. I think that is the common thread for all of these populations.
We've had a good dialogue with the KOLs, and I think that's the approach we're taking in this, because it's really hard when you look at all the different subgroups. Some of them are smaller, some of them are larger. But really, we're going to go to the fundamental of the disease here, where the belief is that the lung fibrosis is really a significant underlying condition for the cough, and that's going to tie all this together.
The FDA did not focus on subgroups, right—
No.
—they really, Annabel, were focused on the fibrotic lung—
Yeah.
—so, yeah. Awsome.
All right, that's helpful. Just one question on the RCC. The SSRE slipped just a little bit to the first quarter, so I'm just wondering with enrollment speed, I'm surprised. Is it just slightly slower enrollment because I didn't expect it to be slower enrollment because of some of the failures out there. Are there any options to increase powering beyond the 152 if you seem to be falling at the low end of the range? Is there any possibility there in terms of clinical effect size?
Well, I'm going to start, and Jim, you can add in.
Yeah.
I think, Annabel, this was always going to be our timelines, always showed December. So, when you say slipped to Q1, it's early Q1. We're sort of talking about weeks here with the holiday. So, just to put it in context, it was always a little tricky because it was December, so it didn't take much, and you sort of fell into January. As far as is there any opportunity to go above 152, and Jim, you can comment on this, but we won't know in the 40%-80% range. We'll only know that it's X and you should upsize Y. I mean, we always over-enroll a little bit, but no, we're not going to try to chase efficacy here. We're going to follow the recommendation.
Yeah. Annabel, I think that we went in with powering assumptions. This is our first parallel arm study in RCC. We learned a lot from the RIVER study, which was the crossover in RCC, and we learned a lot from the CORAL study in terms of the IPF parallel arm study. I think the key here is that we are powering sufficiently. This is a little bit of a statistical adjustment given the effect sizes that we saw previously. So, we will take it with 80% power, which is appropriate for a phase II study. So, if we can get back up there, that is the end we will go with.
Okay. Got it. Thank you.
Thanks, Annabel.
One moment for our next question. Our next question comes from the line of Maxwell Skor of Morgan Stanley. Your line is now open.
Great. Thank you very much. Beyond confirming powering, would the SSRE outcome change how you plan for RCC overall? For example, the target patient segment, phase III sizing, or whether to partner the program? Thank you very much.
We'll wait to look at the full data set. We don't really get much, Maxwell, from the interim other than to confirm powering in the end. We'll wait for the full data set. I think what's changed here is we're in a world where there's nobody else, and I think before we were trying to be mindful of making superiority around any competitive programs, but that's changed. I think we'll take a good look at the data, we'll talk to the agency, and we'll figure out what our phase III program needs to look like. I think much like Jim described on non-IPF ILD, we believe this is also an sNDA and may only require one phase III study. As for partnering, I don't think that's probably on the table because we're a single asset company.
We're going to want to retain global rights. Now, whether commercially we look at, Farrell, you can jump in, co-promotes or anything, I think certainly all those options are on the table. But our intent today is to retain commercial rights for our own program.
Great. Thank you.
Yeah. Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Leland Gershell of Oppenheimer. Your line is now open.
Oh, great. Thanks for providing this update and taking our questions. Just one from us on the non-IPF ILD. So it sounds like the doses that you will be evaluating here just fall effectively in line with what you have looked at historically in cough. I am just wondering, maybe for Jim, do you think that there is any biology that could lead to differences in response in that dose range versus IPF ILD? Obviously, a lot of variability in the biology and the diseases of the various other non-IPF ILDs. Just curious your thoughts there on kind of dose response in that non-IPF ILD. Thanks.
Yeah. No, thanks, Leland. It is a great question, and actually one that we were all very interested in, especially the FDA, because it is all about doing definitive dose ranging. I think you can imagine that we have IPF, which is a very severe and terminal population. This may be, in the eyes of some, a little different than that more IPF, more severe population. So, there is a possibility that you could see something working maybe a little bit better at the 27 mg dose strength.
However, I think when we talk to the KOLs, their belief is that this is all being driven by the fibrotic lung. So, this is really a study to demonstrate what we have and probably see something along the lines of what we saw with IPF. I think that really is, it is a show me stage to make sure that we have our doses right. I do not think we have a different expectation for ILD, but I think we will get some good answers out of this.
Great. Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Ryan Deschner of Raymond James. Your line is now open.
Hey, thanks for the question and congrats on the progress. I am curious what you have been able to learn from the failure of GSK's phase III program with camlipixant that could be helpful in the execution of the LAKE trial or in a subsequent phase III program for RCC, or impact how you are thinking about the upcoming SSRE update. Thanks.
Yeah. Thanks, Ryan, for the question. I think none of the data has been put out, so it has all been sort of through the grapevine, but there has been a lot of stuff drifting around. I would say what I have learned, just from investigators and actually from the company itself, is I do not think placebo was a big problem here, which is really, as you know, has always been the only thing we really needed to care about. I also think that it sounds like their first trial worked reasonably well, and for whatever reason, their second trial, CALM-2, fell apart. It was the longer trial, but that trial was also upsized twice, so a lot of kind of confounding factors in that.
I think as Jim has warned me about from the very beginning, we are better off to follow our own data because there was a lot of extenuating circumstances around those trials. I think they were trying to sort of enrich for this greater than 20 coughers. They upsized the trial twice. They sort of took over the development program midstream. There was a lot of challenging aspects of that. I think, Ryan, we will run our phase IIb, hopefully nail the dose, and then I am hoping that we do not need as big a trial as everybody else has had to run because our effect size will be bigger. That is kind of what we know. I think there is also the Nocion program out there some people are aware of. That drug just did not work. I have seen all the data.
It did not work in 2a, and I think they sort of enrolled 400 patients to show it did not work in phase IIb. I do not think, I do not know, Jim. There was not anything I really learned out of that trial that was really all that enlightening either.
Yeah. I think the key, Ryan, is that we've designed the LAKE trial to really give us the information we need to have. I think, given our experience with chronic cough, with IPF, and with the RIVER data, we can drive our program based on our own results, and we know that we really need to keep the control over the centers we pick and the patients they pick, and we're all over that.
Thank you very much.
Thank you, Ryan.
Thank you. One moment for our next question. Again, as a reminder to ask a question, you'll need to press star one one on your telephone. Our next question comes from the line of Kaveri Pohlman of Clear Street. Your line is now open.
Hi, team. This is Wayne on for Kaveri. Congrats on all the progress this quarter, and thanks for taking our questions. Based on our conversation with some investors, there remains some concerns around ultimate size and durability of the RCC market. How do you think about those concerns, and what commercial initiatives and market development efforts do you believe will be important to drive physician awareness, patient identification, and successful uptake of Haduvio following approval? Thank you.
Yeah, Wayne, this is Farrell. Thank you for the question. When we look at the RCC market, I just want to go back. We're an IPF/ILD-led company. When we're focused on building the market, and we've already started those efforts with our unbranded campaign, we've approached, I think, 93% of pulmonologists that we've already touched talking about the burden of chronic cough and that disease. When we look at the future potential of the RCC market, we'll do our proper market sizing of that market, but we estimate the severe portion, those who have failed other therapies, and aligned with our inclusion/exclusion criteria of being diagnosed for greater than one year, that really narrows that market to around one million patients.
Those are the patients that are going to be seen by pulmonologists primarily. We're still focusing all of our efforts on pulmonology, and as we look at just further market development, that is further off in RCC, right? We are solely focused on developing that IPF and ILD market currently.
Got it. Thank you so much.
Thank you. One moment for our next question. Our next question comes from the line of Debanjana Chatterjee of JonesTrading. Your line is now open.
Hi. Thanks for taking my question, and congrats on all the progress with all the programs. I have a question on SSRE. If the data calls for, the update calls for upsizing, how long would it take to do the additional 52 patient enrollment, and how could it affect the top line readout? I have a quick follow-up.
Yeah. So, hi, Deb. This is Jim. We anticipate that if we have to go to the full increase in cohort, that we would still be able to read that out by the end of 2027.
Sorry, guidance would remain the same.
Yeah.
Second half 2027. Yep.
Okay. And curious, how low would the RCC approvable dose need to be to allow you to launch that as a separate brand from the IPF program and to preserve differential pricing?
Hey, Debanjana , this is Farrell. We will get the dose from that study. It is part of the reason we are testing the 27 mg once a day. If we end up in that range or lower, it does not necessarily even have to be a once a day. Even if we get into really low doses in a twice-a-day delivery, we could still do that. We have work to do there in order to refine what we get out of the trial and really understand how that could impact IPF and ILD, because one of the things we do not want to do is cannibalize the pricing in those indications.
Appreciate the color. Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Serge Belanger of Needham & Co. Your line is now open.
Hi, good afternoon. This is John on for Serge today. Thanks for taking my question. Maybe just one for us today surrounding IP for Haduvio. Curious if there's been any updates to strengthen Haduvio's patent protection over the past few months, and what some initiatives might be on that front as we head into 2027.
Yeah, John, thank you for that question. That's been a big effort and focus around the company this year. I mean, we've always thought about it, but there's been a concerted effort. You'll see in our earnings release we just put out that we actually did get another patent issued around dosing in hepatic impaired patients and non-IPF ILD. That would take that protection out to 2041. So fundamentally, our patenting strategy is method of use patents. We're trying to get the base patents in place for each of our indications. That takes the protection through 2039, and then beyond that, we're filing essentially different dosing claims that have come up through the work Jim's doing and different claims in the label. And we're having good success getting those issued. So, yeah, made some progress on that this quarter.
Great. Thanks for the added color.
Yeah, thank you.
Thank you. One moment for our next question. Our next question comes from the line of Brandon Folkes of H.C. Wainwright. Your line is now open.
Hi, thanks for taking the questions, and congrats on all the progress. Just maybe two from me on RCC. On the LAKE, the sample size re-estimation, can you just talk about how do you account for potentially different doses across different responses, I beg your pardon, across the three active doses? Is the conditional power assessment on SSRE driven by the 54 mg arm or the three active arms? Then secondly, if an upsize is needed, do you get insight into if this is driven by effect size or variability? If so, can you help us think about just variability, the scenario there, just given you are testing lower doses? Thank you.
Yeah. Hi, this is Jim. So, on the SSRE, it is based on the high dose only, the 54 mg twice daily dose. So, we will drive everything based on the analysis of that dose alone. We get very little information from the statisticians. We will know to stay at our current N or upsize by a certain number. We have no read on what the issues are or what may be driving any kind of an upside. The whole idea here is to keep us unbiased, and that's what the purpose of this is. It really is a statistical adjustment. So, in order not to bias the trial, we get very, very little information. We will know all that at the end of the day, obviously, when the study completes, but we don't get that information along the way.
Great. Thank you very much.
One moment for our next question. Our next question comes from the line of Conor MacKay of BMO Capital Markets. Your line is now open.
Hi there. Thanks for taking my question, and congrats on all of the progress. I am wondering if maybe you can speak to how enrollment is progressing for OCEAN-1 and OCEAN-2, and how you would think about timing for an eventual filing in IPF chronic cough. Would you be able to submit the filing with just the OCEAN-2 data and add OCEAN-1 at a later point, or do you need both data sets in hand before you can [inaudible]
I will comment on the first part of that. Jim, you add any. Things are going well. We have a plan. I think site activations are coming along nicely. We have enrollment coming along nicely. It is early. We think that we have reconfirmed our guidance, so we are comfortable with that as of now. I think I would just add a little color. I have gone to all the investigator meetings that Jim and his team have hosted. There is a lot of excitement and enthusiasm around this clinical trial. As you guys probably know, there has been a lot of clinical work done in IPF, a lot of anti-fibrotic work, and I think there is a genuine excitement around having a cough option for people to enroll in. So, yeah, I think we feel good about that. What was the second half of the question?
Really, on the filing strategy.
Yeah
We would report out the trials for OCEAN-2 and OCEAN-1 separately, but we would do a comprehensive integrated NDA filing. That involves the reporting of each of the individual trials, but there is also integrated safety, integrated efficacy. Those will all come together at the end and be filed all as one piece for the clinical portion of the NDA.
Jim, if we were to get fast-tracked, though, we could file in pieces. I know they do not read it all till they get everything.
They do not read anything until the thing is filed.
Okay.
It doesn't necessarily help us on any date, because it's not until the last piece is in.
I appreciate the additional color there. Thanks.
Sure.
Thank you. One moment for our next question. Our next question comes from the line of William Wood of B. Riley Securities. Your line is now open.
Thanks for taking our questions, and congrats on another successful quarter. Two from us, one on ILD, one on LAKE. For LAKE, I was curious, could you provide any comment on how your site activation is ongoing and if that's remained on track or if that's been completely activated? Also, how many patients have you actually enrolled? I know you were expecting the SSRE to read out at 50% completion, but I was curious. Specifically on enrollment and then on ILD, could you just remind us, you've had some discussions now with the FDA. We know this is not IPF, but is it still what is being excluded from the trial in terms of sort of its basket enabling? Then, in terms of your dosing, why not a 27 once daily dose?
Is there a certain level degree of fibrosis or cough that will be needed in this trial? Thank you.
Thanks, William. I will take the first part. I will let Jim do ILD. LAKE, our site activations are on track. Not every site is up and running, but we are a long ways there. That has gone very well. I think the enrollment percentage, our general policy is going to be we will let you know when we hit 50%, and we will give updates after that. We are obviously progressing nicely, for having this come sort of early in the year. When we hit that number, we will let you know. Jim, I will turn it over to you on all the ILD questions.
Yeah, I may have missed the last one, so you can remind me. In terms of the strategy on patient selection, it will be based on a certain level of fibrosis. That is going to be the underlying condition here. We are not looking at it in terms of their specific comorbidities, but the intention is that all of the various comorbidities are eligible for the most part with the underlying fibrosis and chronic cough. I think the last question was. Sorry, you may have to remind me.
What is being excluded? Nobody is excluded, IPF.
Yeah. No, for the ILD, I mean, really nobody's being excluded unless they don't have the level of the fibrosis.
Could you—
Was there one more? Yeah.
—Yeah, one follow-up there. What is the level of fibrosis? I'm just thinking in terms of, is this a sort of like a moderate to severe cough trial that you have to have just fibrosis, meet some bar, or is it there's a certain level of very specific fibrosis in the lungs versus just any that you have to sort of complete or meet? And then dosing specifically, why not a 27 QD once daily dose?
Yeah. In terms of the level of fibrosis, what the KOLs in this space generally have a floor of at least 10% fibrosis in the IPF, non-IPF world to really establish a sort of a reliable condition. Then they sort of break out based on the HRCT scan, what type of ILD they may have. So we're thinking along the lines of that we would have a minimum of about 10% lung fibrosis and without any particular pattern. So that sets the floor for us, but that's pretty much what the experts agree would be establishment of an appropriate level of interstitial lung disease, whether it's IPF or non-IPF. So nothing magical there other than setting the floor. Cough count, I mean, obviously they have to have chronic cough over the period of time. So why not go into a 27 QD dose?
Well, because in the IPF world, we saw that the 27 BID dose was our more effective dose. We are making the assumption that this non-IPF ILD program will follow very closely to the IPF program. We just didn't think that once a day 27 in the ILD space would be sufficient given the data that we have with IPF.
Got it. Appreciate that. Thanks for the extra color .
Sure.
Thanks.
Thank you, William.
Thank you. I am showing no further questions at this time. This concludes our question and answer session. I would like to turn the conference back to Jennifer Good for closing remarks.
We appreciate you joining us for today's call. We will be at the Stifel conference on Wednesday this week and hope to see many of you there. Thank you.
This concludes today's conference call. Thank you for attending. You may now disconnect.