Lexicon Pharmaceuticals, Inc. (LXRX) Earnings Call Transcript & Summary

Welcome to the Lexicon Pharmaceuticals PROGRESS Study Top Line Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, March 3, 2025. I will now turn the call over to Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.

Thank you, Daniel. Good morning, and welcome to the Lexicon conference call to discuss top line results for the pilavapadin Phase IIb PROGRESS study. Joining me today are Dr. Michael Exton, Lexicon's Chief Executive Officer and Director; Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer; Scott Coiante, our Chief Financial Officer; and Dr. Suma Gopinathan, VP of Clinical Development, will join for Q&A. This morning, Lexicon issued a press release announcing top line results for the Phase IIb PROGRESS study evaluating pilavapadin, LX9211 in adults with diabetic peripheral neuropathic pain or DPNP. That press release is available on our website at www.lexpharma.com. A replay of this webcast as well as the slides presented today will also be posted to our website following this call. Before we begin, let me remind you that we will be making forward-looking statements during this call, including statements related to the efficacy, safety, clinical development, regulatory status and therapeutic and commercial potential of pilavapadin and other drugs as well as our business generally. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of pilavapadin and our other drug candidates, strategic alliances and intellectual property as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements, and we refer you to our most recent annual report on Form 10-K and other SEC filings for detailed information describing such risks. I'll now turn the call over to Mike Exton. Mike?

Yes. Well, thanks, Lisa, and good morning, everyone. It's a very exciting and long-awaited day for the Lexicon team, our collaborators and for patients. So Craig is going to discuss the trial in a little more detail shortly, but most importantly, PROGRESS met our objectives as a dose-finding Phase II study and provided meaningful results at the 10-milligram dose. As a reminder, progress is our second study of pilavapadin in DPNP. In our previous RELIEF-DPN-1 Phase IIa study, pilavapadin demonstrated a statistically significant reduction in average daily pain scores or ADPS, compared to placebo at week 6. However, in that study, patients experienced significant tolerability issues, including mild-to-moderate dizziness, which were dose and time-dependent and was related to a 10-fold loading dose that was part of that study's design. This loading dose also resulted in a higher number of treatment discontinuations in that particular study. And so building on the results from RELIEF, this study PROGRESS aimed to identify a dose to advance into Phase III trials, that achieved meaningful pain reduction while also being well tolerated. We modified the dosing regimen to eliminate that day 1 loading dose as well as to test 3 different dosing regimens over an 8-week double-blind treatment period in order to characterize the drug's efficacy and tolerability profile. We utilized a different statistical analysis plan, which modeled the dose response effect across all 3 doses. The goal of the study was to reduce dizziness and drug discontinuations while still providing meaningful pain relief. So we could ultimately choose a single, well-tolerated dosing regimen for the Phase III program. In all doses in the PROGRESS study, including placebo, we observed a clear separation in ADPS from baseline. All the pilavapadin-treated arms showed significantly improved tolerability when compared with RELIEF. In the PROGRESS study, the 10-milligram dose produced meaningful pain reduction, demonstrating separation in ADPS from both baseline and placebo. Importantly, the tolerability concerns observed in the RELIEF study can now be conclusively ascribed to the loading dose administered on day 1. The 20-milligram arm performed no better than placebo at week 8 in the ADPS. This resulted in PROGRESS not achieving the overall primary endpoint given the statistical analysis plan, but the study provided Lexicon with some definitive answers. And so all of that, we believe we have a compelling path forward with the 10-milligram dose. Now as we mentioned before, there's a tremendous need for new non-opioid treatment options for the approximately 9 million people that are currently diagnosed in the U.S. with DPNP. This condition severely impacts the patient's quality of life. It's a constant burden and existing treatment simply don't provide adequate relief for most patients. It's estimated that nearly 60% of patients have tried multiple treatments and in some cases, even leading to patients self-medicating and experimenting with alternatives and only 1/3 of patients indicate that they're satisfied with their treatment. Now there have been recent advances in acute pain. There have been no new non-opioid medications approved for the treatment of neuropathic pain in more than 20 years. And indeed, in the conversations I've had with many patients, I've heard their frustration with the disease and their desire for new treatment options. And so pilavapadin is a novel oral non-opioid investigational AAK1 inhibitor, that we developed specifically for the treatment of neuropathic pain. As a non-opioid therapy and inhibits neurotransmitter reuptake involved in neuropathic pain and has potential application across a number of related indications. We now have data from nearly 600 patients with DPNP who have been treated with pilavapadin. And so with that, I'll turn it over to Craig to go through the results of PROGRESS in some more detail.

Thank you, Mike. I'll now walk you through the top line results for the PROGRESS study. But first, a bit of background on pilavapadin, formerly referred to as 9211 in the PROGRESS study. As Mike summarized, in the previous study, RELIEF-DPNP-1, dose regimen utilizing a tenfold loading dose on day 1 and the 100-milligram, 10-milligram dosing arm but not the 200-milligram, 20-milligram dose arm achieved significantly reduced pain scores as compared to baseline and placebo. However, this loading dose led to increased rates of dizziness, nausea and headache in the treatment arms that appear to be both dose and treatment duration related, with the majority of these events occurring early in treatment. Based on these observations, the PROGRESS study was designed to test a dosing regimen without day 1 tenfold loading dose, and to assess whether this change improved tolerability without negatively impacting efficacy. The Phase IIb PROGRESS study of pilavapadin enrolled 496 adult patients with a diagnosis of DPNP. After a 2-week blinded placebo run-in period, the study evaluated 3 different dosing regimens of pilavapadin, 10 milligrams for 8 weeks, 20 milligrams for 8 weeks and a third arm of 20 milligrams for 1 week followed by 10 milligrams for the remaining 7 weeks. Following the 8-week treatment period, there was a 4-week placebo safety follow-up period. I want to point out that PROGRESS allowed patients to continue on a stable dose of a single underlying non-opioid DPNP medication along with pilavapadin. Enrollment for this study was cleated a quarter early and exceeded the enrollment target by nearly 80 patients, which underscores both the interest in the study and the tremendous need for novel DPNP treatment options. As this was a dose-finding study, the statistical analysis plan was designed to detect a dose response signal based on a prespecified model that assumes separation of all treatment arms from placebo when measuring the primary endpoint of change from baseline to week 8 in ADPS. At the end of January, we held an R&D day webinar focused on pilavapadin in DPNP. While I won't repeat all of the presentation, I do want to underscore a few points from that program. Our corporate objectives with the PROGRESS study were: one, to identify a single dose to take into Phase III studies with; two, similar or better efficacy as we had seen in prior studies of pilavapadin; and three, improved tolerability as compared to the RELIEF study. As Mike mentioned earlier, the PROGRESS study achieved all of these objectives. Now coming to the results of the PROGRESS study. All treatment arms demonstrated reductions in ADPS baseline to week 8. The change from baseline to week 8 was 1.74, 1.7 and 1.38, all negative from baseline in the 10-milligram -- 10-milligram arm and 20-milligram treatment arms, respectively, compared to 1.31 point reduction in the placebo arm. To meet our objective for determining which dose move into later-stage development, the study statistical plan was predicated on a dose response signal based on a prespecified model that assumes separation of all treatment arms from placebo when measuring the primary endpoint of change from baseline to week 8 in ADPS. As a result of this lack of separation in ADPS reduction between the 20-milligram dose arm and placebo, the study did not reach the prespecified statistical significance on the primary endpoint. While we will continue, of course, to evaluate these findings further, we believe that a likely explanation for this lack of separation in the 20-milligram arm is that side effects such as dizziness led to a higher dropout rate and potentially also a lower treatment adherence in those who remained in the study. The benefit of the 10-milligram dose arm is clearly recognizable in both the PROGRESS results announced today as well as our prior RELIEF study results. As you can see from this slide, in both studies, there is a rapid early separation from placebo with the 10-milligram arm that continues throughout the treatment duration. This is particularly notable in PROGRESS where the placebo response was nearly double that of RELIEF and yet there is still a rapid and clinically meaningful separation from placebo. In PROGRESS, the separation continues through the entire 8-week dosing interval. And in Phase III studies, which will likely be 12 weeks in duration, there is the potential for this trend to continue. Based on our observations from the full Phase II DPNP program, both RELIEF and PROGRESS, it is clear that the 10-milligram dose shows consistent, meaningful pain reduction. This totality of evidence gives us great confidence in the advancement of the 10-milligram dose into pivotal Phase III studies. Moving on to tolerability, a primary aim of the PROGRESS study was to evaluate whether levels of dizziness and drug discontinuations in RELIEF were related to the day 1 loading dose, which we removed in PROGRESS. On this slide, you can see that the completion rate in the 10-milligram arm was similar to placebo. Completion rates in the other arms were lower and lowest in the 20-milligram arm with only 77% completing treatment. This higher rate of discontinuation in the 20-milligram arm may explain why efficacy did not separate from placebo, and this will be something we will continue to assess as we analyze the full study results. In patients who discontinued and had TEAE or Treatment Emergent Adverse Event, the only adverse events that resulted in discontinuations and crossed 2% or greater in prevalence in any of the treatment arms were dizziness and nausea. Compared to RELIEF-DPN study, removing the loading dose, markedly improved tolerability particularly in the 10-milligram arm. Overall, adverse events were more frequent in the pilavapadin treatment arms and placebo with higher AEs observed in the 20-milligram arm. Nearly all AEs were reported as mild or moderate. While there were discontinuations associated with dizziness and nausea, those occurred most frequently in the 20-milligram arm. The overall discontinuation rate in the 10-milligram arm was similar to placebo, although discontinuations associated with treatment emergent adverse events were greater in all pilavapadin doses compared to placebo, again, with the highest rates in the 20-milligram dose arm. In summary, the efficacy and tolerability of the 10-milligram dose observed across both RELIEF and PROGRESS offer the best profile amongst all doses studied for advancing into further clinical development. As always, with top line results, we will continue to analyze these results in more detail as well as potentially presenting the full results from the PROGRESS study at an upcoming medical meeting and submitting for publication in a peer-reviewed journal. While we will have an end of Phase II meeting with -- we will also have an end of Phase II meeting with the FDA, and we look forward to providing you further updates in the coming months. Before I turn it back over to Mike to wrap up with some closing thoughts, I did want to take a moment to thank the clinical development team at Lexicon, whose expertise and knowledge propelled the study forward and we exceeded all of our operational targets. I also wanted to thank the investigators and the study sites whose participation in advancing this program was top notch. And most importantly, I'd like to thank the patients who participated without whom this trial would not have been possible. Mike?

Yes. Great. Thanks, Greg. So a few closing comments here, and then we'll get into the best part of the Q&A. So -- as we mentioned in our press release this morning, in addition to advancing the preparation for the Phase III program, we're also in active partnership discussions for Pilavapadin. The enormous potential of the medicine has generated significant interest from potential partners who were acutely interested in seeing the pilavapadin -- we could remove the tolerability issues that we saw with the original RELIEF data. And these data, of course, support that thought and the program even further. So we feel that having a partner who's able to augment our existing clinical development capabilities and with expansive commercial reach would give pilavapadin the best chance of reaching the significant numbers of patients globally who would benefit from the therapy. And so as a reminder, pilavapadin has received the fast track designation from the FDA for development in DPNP. So all in all, we're looking at all of our options to hit the gas with pilavapadin, the 10-milligram dose, which has the potential to enter Phase III in DPNP this year 2025. We'd like to express our deepest gratitude for the patients, investigators, trial site coordinators who participated in the PROGRESS trial, who've been instrumental in advancing our understanding of pilavapadin in DPNP. So -- with that, we've got plenty of time for Q&A. So operator, if you'd please open the line.

[Operator Instructions] And our first question comes from Yasmeen Rahimi with Piper Sandler.

Congrats on the data. I know the data is fresh and lots of analysis and additional data that we'll be seeing, which we very much look forward to. I guess between now and the next time we hear additional data, like what are the type of analyses you would want to look into? Especially in order to really kind of get the understanding why that maybe the 20-mg dose group was ineffective or maybe there is an opportunity to move it forward to Phase III. So like maybe to the extent you could comment on what are the type of analysis you would like to do to complete that? That would be helpful. And then did you see any -- and then one last one, I apologize. Did you see any differences in the 10-mg dose group based on the background therapies of the patients? And I'll jump back in the queue.

Great. Thanks, Yas. And I'll let Craig address that or both those questions, I guess really.

Yes. Thanks, Mike. And Suma, please comment as well. First and most importantly, Yas, on the 20-milligram arm, one of the things that we're going to really take a look at is the correlating the dropout rate to the efficacy. But importantly, what we found in the trial -- in the RELIEF trial is when we did the PK, even though patients stayed in the trial, they weren't always taking a full dose of the medication. So I think that is one of the other issues we're looking at. If you look at the curve that we have on the comparison of the time course, you can see that there's an initial drop in the 20, but those curves come back together with placebo by week 8, which is also an indication that there is a loss of efficacy, which we believe is probably related to patients not taking their full medication. I wanted to go back and reiterate why we picked the 20-milligram dose arm to begin with, and that was based on looking at PK and exposure. And what we found is that the more drug patients had in their serum in their bloodstream, the greater the efficacy. I think the issue is going to be practically is if the patients aren't really happy on the drug -- aren't tolerating it that well, will they take it? So there's one issue physiologically, if you have more drug on board, you're going to get a greater degree of efficacy. The issue is will those patients really be able to take it. And Suma, I don't know if you want to add anything more about that before moving on to Yas' second question.

No, I think you covered it, Craig. Yas, I think what we're looking -- we would be looking into is the impact of patient adherence on the therapy, as Craig mentioned, and that is a key factor that we will be analyzing in the months to come.

Yes. And Yas, on your second question regarding the background treatment, that, again, will be one of the analysis we do is we analyze the full data set. Just as a reminder, they're about 30% of the patients were on an underlying DPNP medication. So that means there's only going to be about 30 patients per arm that we can analyze. So I think we're certainly going to look at that, but I think we're going to have to obviously take that small sample size. We did stratify for it, but I think we'll have to be just cautious of not over-interpreting that data when it's available.

Our next question comes from Roanna Ruiz with Leerink Partners.

Two quick questions for me. First one, could you talk about how you plan to treat the discontinuations in the overall statistical plan for the PROGRESS trial? And given the higher discontinuation rate at the higher dose, I was also curious if you could sort of explain or give some theories about the possible impact of discontinuations on the ADPS score efficacy. And then secondly, just thinking ahead, could you talk a bit about your plans for Phase III, moving forward with the 10-milligram dose. Are there any trial design changes that you might consider moving forward with a larger trial?

Suma, do you want to talk about the discontinuations because you've been closest to the data.

Absolutely. Thank you, Roanna. The discontinuations in this was treated using the MMRM method and what we will be, as we -- Craig had previously mentioned, this is something we need to look at in terms of how the discontinuations have affected the primary endpoint, and we also need to understand how treatment adherence in the 20-milligram dose has had an impact on what we are seeing at the week 8 efficacy.

Roanna, before moving on, I did want to say that we did perform an additional analysis. Again, this is a post-hoc statistical analysis. But as Mike and I both mentioned, the modeling work, the statistical methodology we used was a model I'd assume that all 3 doses were going to be active. Since the 20-milligram dose performed no better than placebo, we re-ran the same exact statistical methodology we used running the model with only the 2 doses, the 10 and the 20-10. And what we found in that, again, using all the same data on an intent-to-treat basis, that drop in pain score compared to placebo then is significant at a p-value of 0.04. So again, even with the doubling of the placebo response in this study compared to RELIEF, the overall drop in pain score in the 10-milligram dosing arm was 1.75 points. So there was a large drop in pain score, and even taking the comparison to placebo when you rerun the identical analysis dropping out the 20 and just running it with the 10 and the 20-10, the p-value in both those arms is about 0.4.

So to your follow-up question then and Craig, maybe you want to jump in on this as well, Roanna, what tweaks might we make to the Phase III program. I think we're confident in the overall structure of the program now demonstrated between RELIEF and PROGRESS that we've got a good paradigm. Clearly, in PROGRESS, we see a pretty significant placebo response. And as Craig mentioned, despite a pretty huge placebo response, we still see meaningful separation of the 10-milligram arm, which is -- which gives us a lot of confidence. But clearly, we want to go back and look at some of the rationale and reasons, the explanations for why the placebo response in RELIEF is so much more significant than -- the other way around in PROGRESS is so much more than RELIEF. And we may make some tweaks into the execution and the protocol, but I think we're confident in the trial design as we have it.

Yes. I do think, though, Roanna, one of the elements here is patient education and patient selection are really, really important. And I do think continuing to work with the patients to make sure that we're getting accurate feedback from the patients on they're taking their medications, working with sites that have deep experience with the patients they enroll wherever possible. Those kinds of very operational issues, I think we continue to learn as we run these studies.

Our next question comes from Yigal Nochomovitz with Citi.

This is Lynn on for Yigal. I just wanted to ask, I know you mentioned you're continuing to evaluate some partnerships and things like that. So -- just wondering if you could talk about those potential opportunities there and what the ideal partner looks like for you? And then just one more -- wondering if you could remind us of the market opportunity for DPNP? I know you mentioned there's been recent advancements in acute pain and nothing specifically for DPNP. So just wondering if there's any market research or doc checks or anything that you can point to that kind of demonstrates what percent the market you're going to capture?

Great. Yes. I appreciate the question. So actually, there's been a lot of interest from a number of different parties from multinationals through to more regional players from -- who have an interest in the pain space. And in fact, the company that would be an ideal partner, it doesn't come in an exact form, because, clearly having a background in neuroscience is helpful and having the commercial reach that would make sure that this reaches its market potential and at the same time, brings some clinical experience would be helpful. But I think partners generally see neuropathic pain as a huge area of unmet need and a huge area of opportunity. And so there will be a number and are a number of interested partners to have these discussions with. So the market opportunity, as I mentioned, in the U.S. alone, there's 9 million patients with the diagnosis of DPNP. And so you can work out that this is clearly a multibillion-dollar opportunity in the U.S. alone. And it's for those reasons that there are significant -- significant interest from potential partners.

Our next question comes from Joe Pantginis with H.C. Wainright.

So Mike and team, going to your comments about the much higher placebo rate in PROGRESS versus RELIEF. Do you have any -- as we're awaiting obviously, the broader data set, do you have any first thoughts now are there anything that stick out with regard to the demographics between the two studies? Obviously, the background therapy percentage is around 30% for PROGRESS you said, but any broad thoughts here? And also sorry, how that might account for -- your powering assumptions for Phase III as you're seeing a higher level of variability for the placebo?

Yes, Joe, it's Craig. I'll take a shot at that. So what we did see in the demographics of this trial as it was a little different than the RELIEF study. The age was similar in the low 60s. They were somewhat more men in this study than the RELIEF trial, it was about 60% men and RELIEF trial was about 50%, 55% men. It was a greater representation of African-Americans in the study, 30% of the patients in the trial were African-American versus about 15% or 18% in RELIEF. And we don't know at this point until we analyze the full data set whether that had anything to do with the underlying placebo rate. I can share with you that if you look across in the pregabalin study is probably the best full data set, placebo rates vary dramatically from study to study. They vary from 0.7 or so like we saw in RELIEF, to similar to the rate we saw in this trial. This is kind of the extreme of what the placebo rates are about 1.5 points in historically what has been seen. So I think it does vary from study to study, which reinforces why it's so important to include a placebo in all these trials. And also Joe. You know this one, I know many on the call also know this, but just to reinforce it, that all the other trials that have been reported are reporting statistical significance of patient to their baseline, not placebo-adjusted reductions. And for example, some of the agents that have been out there, they don't show any separation from placebo at all, and we've shown significant -- or meaningfully -- clinically meaningful significance of reduction, both in terms of time and magnitude twice now compared to placebo regardless of the underlying placebo rate. So I think that -- we'll obviously continue to look at that, but I think part of it is just the variability in these trials from trial to trial, which is, again, why it's so important to have a placebo control. The impact of that on trial design, I think that will be something we'll have to look at a little bit more as time goes on. But right now, I believe that if you increase the sample size from roughly 100 per group that we had in this trial, to roughly 300 to 350 patients that were thinking about per arm in the Phase III program, plus extending the duration from 6 to 8 weeks to 12 weeks we feel pretty confident that, first of all, the trends in pain reduction will continue with the treatment arm, especially with a much lower dropout rate and with many more patients -- the variance of the data should also shrink, which should improve the statistical reliability of the data set.

Yes. Let me just add sort of a little bit of color to that because it's really important that what we've been able to achieve here is clearly identify 10 milligrams is a dose to take forward into the Phase III program. And clearly, we'll talk to the FDA about that. But that enables what -- ensuring that we have sufficient power to manage variability of any placebo response that we'll get. We can still keep those trials relatively small. It will be 1 dose versus placebo and independent of -- or depending on what powering a patient number that we need to get there, they're still going to be relatively small trials and straightforward to run now that we have identified that 1 single effective and tolerable dose. And so that gives us confidence going to the FDA and preparing all the things that a Phase III program would need to get up and running in this year.

Our next question comes from Joseph Stringer with Needham.

What was the relative percentage improvement in ADPS between the 10-mg arm and placebo, if you take into account their respective baselines. For example, if you look at the RELIEF Phase IIb -- Phase II trial, it was around -- I think it was around 10%, numerically better than placebo on a relative basis. The reason I ask is that do you plan to position the drug as potentially an add-on therapy. What's the extra benefit that you're getting percentage-wise? And would you consider this clinically meaningful? And then second question is in the 10-mg arm, dizziness and nausea discontinuations were higher than the placebo. When did these events, the dizziness and nausea occur? Was it throughout the treatment period for the completers? Or was it early on, on initial dosing?

Yes. Joey, could you just clarify a bit more for me the first question? I'm -- I just didn't follow it completely with the percent improvement.

Yes. If you take -- I don't think you showed baseline values in this top line. But if you take into account the baseline values for both the placebo and the 10-mg arm, you showed absolute differences here between 10-mg and placebo. But on a -- if you take into account the baseline for each of those, what was the relative percentage improvement in ADPS? And in this trial. I think if you perhaps looked at the previous Phase II trial, it was like a 10% improvement for LX9211.

Okay. I think I see your question. So let me try to answer it. We -- the baseline pain score in this trial was a bit higher than in the RELIEF trial. I believe it was about 6.9%. So if you're looking at the reduction in pain score of that, I'm not sure, Joe, if that helps answer your question. We've shown that the reduction in pain score from baseline in the treatment arm was 1.74 versus about 1.3 in placebo, and that's the difference of 0.43 points. Are those the numbers that you're looking for?

Yes, that's helpful. That's helpful.

I don't want to over answer the question. I think the only missing piece to answer the question you're trying to get at was the baseline pain score, which was about -- 6.9, Suma if that's accurate?

Yes. So Joe, we had more patients in this trial who had severe -- who were classified as having severe pain that is a score on the ADPS scale of 8 and above. So we had about 33% in this trial who were having the severe pain compared to about 25% in the RELIEF trial and that is how the ADPS score is actually closer to 7, it's about 6.9 to 7. And that is pretty even across -- by the randomization, the baseline pain score fairly even across all treatment arms about 6.9 to 7. And from that, each of the patients in the treatment arm, what they are experiencing in the 10-milligram arm is close to 2, right, a 1.74 drop in ADPS from baseline.

And Joe, to answer your second question, we haven't yet fully analyzed the data to look at the time onset of the adverse events of the TEAEs. I can say, though, I think we mentioned this in the prepared remarks, is that the dizziness seems to be dose related and the nausea and the headache don't seem to be as much dose related, but the major reason for the dropouts. And again, I'll remind you that the only 2 at treatment-emergent adverse events that resulted in dropouts -- at greater than 2% were the dizziness and the headache. So I think there's going to be a relatively small data set to work with because there weren't that many dropouts particularly in the 10-milligram arm, but we're going to analyze those kinds of things for sure.

Our next question comes from Andrew Tsai with Jefferies.

This is Matt Marcus on for Andrew. Just sort of a continuation of the last question. I think your experts also want to see the percent of patients who achieved the 30% and 50% reduction in pain scores from baseline. What was that proportion of patients who saw improvements at both of those thresholds? And then also for your Phase III, what kind of placebo-adjusted separation do you think you can get in that study?

Yes. So like all of the secondary end points, Matt, we have that when we have the full data set. And I would assume that when we have a scientific presentation later this year, those kinds of data will be included in that. I don't think we've fully analyzed the data to make an assumption of what a pain score reduction would be to power the Phase III trial. But I can say that with both relief and progress, it was a placebo-adjusted reduction of 0.6 that we powered the trials around.

I'm showing no further questions at this time. I would now like to turn it back to Michael Exton for closing remarks.

Well, thanks very much, operator. And great to speak with you all this morning and really appreciate the questions. And we're looking forward to diving deeper into the data as it becomes available. But just to summarize where we're at that in this dose-finding study, we've been able to clearly confirm that the 10-milligram arm is an effective and tolerable dose of taking data across the Phase II program that we feel confident in developing a Phase III and the pivotal trial methodology to be able to demonstrate that this is an effective and safe medicine into the market and for looking to provide the first oral non-opioid treatment for neuropathic pain. So I look forward to further discussing with you and appreciate your time this morning.

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