Welcome to the Lexicon Pharmaceuticals Progress Study Topline Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a brief question-and-answer session. As a reminder, this call is being recorded today, March 3rd, 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 II-B PROGRESS study. Joining me today are Dr. Mike 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, who will join for Q&A. This morning, Lexicon issued a press release announcing top-line results for the phase II-B 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.
Yeah, thanks, Lisa, and good morning, everyone. It's a very exciting and long-awaited day for the Lexicon team, our collaborators, and for patients. Craig's 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 mg dose. As a reminder, PROGRESS is our second study of Pilavapadin in DPNP. In our previous RELIEF-DPN-1 phase II-A study, Pilavapadin demonstrated statistically significant reduction in average daily pain scores, or ADPS, compared to placebo at week six. 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 high number of treatment discontinuations in that particular study.
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-one loading dose, as well as to test three different dosing regimens over an eight-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 three 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 mg 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 one. The 20 mg arm performed no better than placebo at week eight in the ADPS. This resulted in PROGRESS not achieving the overall primary endpoint, given that statistical analysis plan, but the study provided Lexicon with some definitive answers. All of that, we believe we have a compelling path forward with the 10 mg dose. Now, as we mentioned before, there is 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 is a constant burden, and existing treatments simply do not 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 a third of patients indicate that they're satisfied with their treatment. 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. 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. 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, it 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.
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. First, a bit of background on Pilavapadin, formerly referred to as 9211, and the PROGRESS study. As Mike summarized, in the previous study, RELIEF-DPN-1, dose regimens utilizing a 10-fold loading dose on day one and the 100 mg, 10 mg dosing arm, but not the 200 mg, 20 mg 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 one 10-fold loading dose and to assess whether this change improved tolerability without negatively impacting efficacy.
The phase II-B PROGRESS study of Pilavapadin enrolled 496 adult patients with a diagnosis of DPNP. After a two-week blinded placebo run-in period, the study evaluated three different dosing regimens of Pilavapadin: 10 mg for eight weeks, 20 mg for eight weeks, and a third arm of 20 mg for one week, followed by 10 mg for the remaining seven weeks. Following the eight-week treatment period, there was a four-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 completed 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 pre-specified model that assumed separation of all treatment arms from placebo when measuring the primary endpoint of change from baseline to week eight in ADPS. At the end of January, we held an R&D day webinar focused on Pilavapadin and DPNP. While I won't repeat all of that 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 from baseline to week eight. The change from baseline to week eight was 1.74, 1.7, and 1.38, all negative from baseline in the 10 mg, 20-10 mg arm, and 20 mg treatment arms, respectively, compared to 1.31-point reduction in the placebo arm. To meet our objective for determining which dose to move into later stage development, the study's statistical plan was predicated on a dose-response signal based on a pre-specified model that assumed separation of all treatment arms from placebo when measuring the primary endpoint of change from baseline to week eight in ADPS. As a result of this lack of separation in ADPS reduction between the 20 mg dose arm and placebo, the study did not reach the pre-specified 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 mg 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 mg 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 mg 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 eight-week dosing interval.
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 mg dose shows consistent, meaningful pain reduction. This totality of evidence gives us great confidence in the advancement of the 10 mg 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-one loading dose, which we removed in PROGRESS. On this slide, you can see that the completion rate in the 10 mg arm was similar to placebo. Completion rates in the other arms were lower, and lowest in the 20 mg arm with only 77% completing treatment.
This higher rate of discontinuation in the 20 mg 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 a 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 the RELIEF-DPN study, removing the loading dose markedly improved tolerability, particularly in the 10 mg arm. Overall, adverse events were more frequent in the Pilavapadin treatment arms than placebo, with higher AEs observed in the 20 mg 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 mg arm.
The overall discontinuation rate in the 10 mg 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 mg dose arm. In summary, the efficacy and tolerability of the 10 mg 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 2 meeting with the FDA, 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 this 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. Most importantly, I'd like to thank the patients who participated, without whom this trial would not have been possible. Mike?
Yeah, great. Thanks, Craig. A few closing comments here, and then we'll get into the best part of the Q&A. 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 that Pilavapadin, we could remove the tolerability issues that we saw with the original RELIEF data. These data, of course, support that thought and the program even further. 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.
As a reminder, Pilavapadin has received a fast-track designation from the FDA for development in DPNP. All in all, we're looking at all of our options to hit the gas with Pilavapadin, the 10 mg 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. With that, we've got plenty of time for Q&A. Operator, if you'd please open the line.
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. In the interest of time, we ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from Yasmeen Rahimi with Piper Sandler. Your line is open.
Good morning, team. Congrats on the data. I know the data is fresh and lots of analyses 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, 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? To the extent you could comment on what are the type of analyses you would like to do to complete that, that would be helpful. And then did you see any—
Yeah.
Yep. One last one, I apologize. Did you see any differences in the 10 mg dose group based on the background therapies of the patients? I'll jump back in the queue.
Great. Thanks, Yas. I will let Craig address both those questions, I guess, really.
Yeah, thanks, Mike. Suma, please comment as well. First and most importantly, Yas, on the 20 mg arm, one of the things that we're going to really take a look at is correlating the dropout rate to the efficacy. Importantly, what we found in the RELIEF trial is when we did the PK, even though patients stayed in the trial, they weren't always taking the full dose of the medication. 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 eight, 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 mg dose arm to begin with, and that was based on looking at PK and exposure. 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 if the patients aren't really happy on the drug, aren't tolerating it that well, will they take it? There is 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? 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 are 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.
Thank you so much.
I think Yas.
Thank you.
Yeah. Yas, on your second question regarding the background treatment, that again will be one of the analyses we do as we analyze the full data set. Just as a reminder, there are about 30% of the patients who are on an underlying DPNP medication. That means there is only going to be about 30 patients per arm that we can analyze. I think we are certainly going to look at that, but I think we are going to have to obviously take that small sample size. We did stratify for it, but I think we will have to be just cautious of not over-interpreting that data when it is available.
Thank you very much.
Thank you. Our next question comes from Roanna Ruiz with Leerink Partners. Your line is open.
Hey, good morning, everyone. 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? Given the higher discontinuation rate at the higher dose, I was also curious if you could sort of explain or give some of your theories about the possible impact of discontinuations on the ADPS score efficacy. Secondly, just thinking ahead, could you talk a bit about your plans for phase III moving forward with the 10 mg 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 that data?
Absolutely. Thank you, Roanna. The discontinuations in this were treated using the MMRM method. What we will be—as 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 mg dose has had an impact on what we are seeing at the week eight efficacy.
Roanna, before moving on, I did want to say that we did perform an additional analysis. Again, this was a post-hoc statistical analysis. As Mike and I both mentioned, the modeling work, the statistical methodology we used was a model that assumed that all three doses were going to be active. Since the 20 mg dose performed no better than placebo, we reran the same exact statistical methodology we used, running the model with only the two doses, the 10 and the 20/10. What we found in that, again, using all the same data on an intensity basis, that drop in pain score compared to placebo then is significant at a p-value of 0.04. Again, even with a doubling of the placebo response in this study compared to RELIEF, the overall drop in pain score in the 10 mg dosing arm was 1.75 points.
There was a large drop in pain score. 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.
To your follow-up question then, and Craig, maybe you want to jump in on this as well, Roanna, is 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. As Craig mentioned, despite a pretty huge placebo response, we still see meaningful separation of the 10 mg arm, which gives us a lot of confidence. 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—sorry, the other way around—in PROGRESS is so much more than RELIEF.
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.
Yeah. I do think, though, Roanna, one of the elements here is patient education and patient selection are really, really important. I do think continuing to work with the patients to make sure that we're getting accurate feedback from the patients on their 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.
Got it. Thanks.
Thank you. Our next question comes from Yigal Nochomovitz with Citi . Your line is open.
Hi, this is Rena on Yigal. Thanks for taking my question. I just wanted to ask, I know you mentioned you're continuing to evaluate some partnerships and things like that. Just wondering if you could talk about those potential opportunities there and what the ideal partner looks like for you. 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, but nothing specifically for DPNP. Just wondering if there's any market research or doc checks or anything that you can point to that kind of demonstrates what percent of the market you need to capture.
Great. Yes. Appreciate the question. Actually, there's been a lot of interest from a number of different parties, from multinationals through to more regional players, who have an interest in the pain space. In fact, the company that would be an ideal partner 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. I think partners generally see neuropathic pain as a huge area of unmet need and a huge area of opportunity. There will be a number and are a number of interested partners to have these discussions with. The market opportunity, as I mentioned, in the U.S. alone, there's 9 million patients with the diagnosis of DPNP.
You can work out that this is clearly a multi-billion dollar opportunity in the U.S. alone. It is for those reasons that there are significant interest from potential partners.
Thanks for taking my question.
Thank you. Our next question comes from Joe Pantginis with H.C. Wainwright. Your line is open.
Hey, everybody. Good morning. Thanks for taking the questions. 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? Is there anything that sticks 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? Also, sorry, that might account for your powering assumptions for phase III as you're seeing a higher level of variability for the placebo. Thanks.
Yeah, Joe, it's Craig. I'll take a shot at that. What we did see in the demographics of this trial is it was a little different than the RELIEF study. The age was similar in the low 60s. There were somewhat more men in this study than the RELIEF trial. It was about 60% men, and the RELIEF trial was about 50-55% men. There 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. 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 studies, it's probably the best full data set, placebo rates vary dramatically from study to study.
They vary from 0.7 or so that, 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 one and a half points in historically what has been seen. I think it does vary from study to study, which reinforces why it's so important to include a placebo in all these trials. I also, Joe, and you know this, and 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. For example, some of the agents that have been out there, they do not show any separation from placebo at all.
We have 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. I think that we will 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 is so important to have a placebo control. The impact of that on trial design, I think that will be something we will have to look at a little bit more as time goes on.
Right now, I believe that if you increase the sample size from roughly 100 per group that we had in this trial to roughly 350 patients that we're thinking about per arm in the phase III program, plus extending the duration from 6- 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 the much lower dropout rate. With many more patients, the variance of the data should also shrink, which should improve the statistical reliability of the data set.
Yeah. 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 mg as a dose to take forward into the phase III program. Clearly, we'll talk to the FDA about that. That enables, while 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'll be one dose versus placebo. Independent of or depending on what powering and 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 one single effective and tolerable dose.
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.
Got it. Thank you very much. Looking forward to the next steps.
Thank you. Our next question comes from Joseph Stringer with Needham. Your line is open.
Hi, good morning. Thanks for taking our questions. 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 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 if 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? 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 upon initial dosing? Thanks.
Yeah. Joe, could you just clarify a bit more for me the first question? I'm sorry, I just didn't follow it completely with the percent improvement.
Yeah. 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. If you take into account the baseline for each of those, what was the relative percentage improvement in ADPS 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. Let me try to answer it. The baseline pain score in this trial was a bit higher than in the RELIEF trial. I believe it was about 6.9. 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 a difference of 0.43 points. Are those the numbers that you're looking for?
Yeah. 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.
That's correct. Yeah.
6.9, if that's accurate.
Yes. 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. We had about 33% in this trial who were having the severe pain compared to about 25% in the RELIEF trial. That is how the ADPS score is actually closer to 7. It is about 6.9- 7. That is pretty even across by the randomization. The baseline pain score is fairly even across all treatment arms, about 6.9- 7. From that, each of the patients in the treatment arm, what they are experiencing in the 10 mg arm is close to 2, right? A 1.74 drop in ADPS from baseline.
Okay. Got it. Makes sense.
Joe, to answer your second question, we have not yet fully analyzed the data to look at the time onset of the adverse events of the TEAEs. I can say, though, and I think we mentioned this in the prepared remarks, that the dizziness seems to be dose-related, and the nausea and the headache do not seem to be as much dose-related, but are the major reason for the dropouts. I will remind you that the only two treatment-emergent adverse events that resulted in dropouts greater than 2% were the dizziness and the headache. I think there is going to be a relatively small data set to work with because there were not that many dropouts, particularly in the 10 mg arm. We are going to analyze those kinds of things for sure.
Okay. Got it. Thank you for taking our questions.
Thank you. Our next question comes from Andrew Tsai with Jefferies. Your line is open.
Hey, good morning. This is Matt Barcus on for Andrew. Just sort of a continuation of the last question. I think your experts also wanted to see the percent of patients who achieve a 30% and 50% reduction in pain scores from baseline. What was that proportion of patients who saw improvements at both of those thresholds? Also for your phase III, what kind of placebo-adjusted separation do you think you can get in that study? Thanks.
Yeah. Like all of the secondary endpoints, Matt, we'll have that when we have the full data set. 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. I can say that with both RELIEF and with PROGRESS, it was a placebo-adjusted reduction of 0.6 that we powered the trials around.
Got it. Okay. Thank you so much.
Thank you. I'm showing no further questions at this time. Now I'd like to turn it back to Mike Exton for closing remarks.
Thank you very much, Operator. Great to speak with you all this morning and really appreciate the questions. We are looking forward to diving deeper into the data as it becomes available. Just to summarize where we are at, in this dose-finding study, we have been able to clearly confirm that the 10 mg arm is an effective and tolerable dose. Taking data across the phase II program, 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 to take into the market and for looking to provide the first oral non-opioid treatment for neuropathic pain. We 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.