Lexicon Pharmaceuticals Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 6, 2025

There are 10 speakers on the call.

Operator

Welcome to the Lexicon Pharmaceuticals Fourth Quarter twenty twenty four Financial 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, 03/06/2025. I will now turn the call over to Lisa DiFrancesco, SVP, Investor Relations and Corporate Communications for Lexicon.

Operator

Please go ahead, Lisa.

Speaker 1

Thank you, Gigi. Good afternoon, and welcome to the Lexicon Pharmaceuticals' fourth quarter and full year twenty twenty four Financial Results Conference Call. Joining me today for prepared remarks are Doctor. Mike Exton, Lexicon's Chief Executive Officer and Director and Scott Chianti, Senior Vice President and Chief Financial Officer. Sir Craig Granowitz, Senior Vice President and Chief Medical Officer will also join us for Q and A.

Speaker 1

This afternoon, Lexicon issued a press release announcing our financial results for the fourth quarter of twenty twenty four, which are available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call along with a slide presentation is also available on our website. During this call, we will review the information provided in the release, provide a corporate update, and then use the remainder of our time to answer your question. Before we begin, let me remind you that we will be making forward looking statements, including statements related to safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of pilavapidin, LX-nine thousand eight hundred and fifty one, sotagliflozin and our other drug programs as well as our business generally. These statements may also include characterizations and projections relating to the clinical development, regulatory status and market opportunity for our drug programs and the commercial performance of INPEFA for heart failure.

Speaker 1

This call may also contain forward looking statements related to our growth and future operating results, discovery and development of our 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 would now like to turn the call over to Mike Exton. Mike?

Speaker 2

Great. Thanks, Lisa, and good afternoon, everyone. Thanks for joining the call. Look, we've had a busy start to 2025 already, including our announcement on Monday of top line results from our progress Phase 2b study of filabapentin in diabetic peripheral neuropathic pain or DPNP. But as we take a moment to look back and reflect on 2024, I'm immensely proud of the resilience and adaptability of the team in keeping our pipeline of novel medicines moving forward and advancing our lead to succeed strategy.

Speaker 2

Last year, we strategically reposition Lexicon to focus the company and its resources on our clinical development programs and some key highlights from these programs included the early completion of enrollment for our progress study, great progress in our pivotal Phase three SONATA HCM study of sotagliflozin in hypertrophic cardiomyopathy or HCM, where we continue to enroll patients as planned, advancing IND enabling studies of LX LX9851 in obesity and related cardiovascular disorders. And lastly, we reinvigorated our business development efforts, including a significant licensing agreement with VITRIS for sotagliflozin outside of The U. S. And Europe. Now I want to begin today's overview with our most recent significant development.

Speaker 2

On Monday, we issued a press release and held a conference call to discuss the top line results for PROGRESS, the Phase 2b dose finding study of pilobapitan, our oral non opioid drug candidate for DPNP. Now the two most important takeaways from our top line announcement this week are, first, in all doses in the progress study, including placebo, we observed a clear separation in ADPS from baseline with a ten milligram dose also showing meaningful improvement compared to placebo. Secondly, all filabapatin treated arm showed improved tolerability when compared with our previous relief DPN study. Indeed the ten milligram dose of pilobapitan showed particularly better tolerability as compared to relief. And for these reasons, we successfully achieved our corporate objectives for progress with the ten milligram dose.

Speaker 2

And so these data in combination with the data from the release study give us greater confidence in the potential of pilobapatine to be the first novel oral non opioid DPNP medication in more than two decades. And we're moving forward with a ten milligram dose. As you can see in this slide, filabapentin ten milligrams performed strongly, improving ADPS at week eight, reducing it by 1.74 points from baseline. Now as we continue to analyze the data, there are already signals that give us even greater confidence to advance the ten milligram dose in the pivotal trials. Cooling the two arms that utilize ten milligrams, the ten milligram dose plus the 20 plus 10 arm, this POC analysis shows an approximately 0.6 ADPS reduction versus placebo as early as week two, which is maintained throughout the treatment period.

Speaker 2

Interestingly, while the pain reduction curve of the placebo arm appears to flatten out in the last four weeks of the trial, the ten milligram dose continues to consistently reduce ADPS scores, suggesting that in pivotal trials of twelve weeks duration further separation may be achievable. Furthermore, as we outlined on Monday, the ten milligram dose was well tolerated. In progress, as many patients with ten milligram pilavapidin as with placebo completed trial, conclusively ascribing the tolerability performance in the previous relief study for the day one tenfold loading dose. This gives us confidence in the tolerability of ten milligrams of pilabapatine in Phase three trials. We continue to analyze further data and look forward to presenting the full findings from the PROGRESS study at a future medical meeting.

Speaker 2

So now I want to talk about what pilavapitan can potentially mean for patients. CPNP is a large and growing condition that impacts approximately nine million people in The U. S. It's a chronic and progressive pain disorder that severely impairs people's quality of life with a majority of patients experiencing moderate to severe pain. When we speak with patients and physicians, it's truly devastating to hear how it impacts their everyday life, their ability to sleep at night, their mental health and their relationships.

Speaker 2

CPNP can also lead to loss of sensation, loss of balance, falls and fractures and a wealth of other complications. But importantly, currently available treatments simply don't provide adequate relief. It's estimated about sixty percent of patients have tried multiple therapies and only a third are somewhat satisfied with their treatment. Now, marker research, we heard numerous HCPs and patients report an immense need for new treatment options. And in particular a simple, easy to use non opioid treatment options for DPNP.

Speaker 2

And finally, with about a third of DPNP patients still resorting to short term opioid use for pain relief even today, when we know the potentially devastating effects of these treatments, this space is primed for reform. HCPs, legislators and policymakers prior initiatives such as the Alternative to Pain Act provide tailwinds to support movement towards new non opioid options. Next, I'd like to discuss LX-nine thousand eight hundred and fifty one, where we are continuing to advance IND enabling studies. LX9851 is our first in class oral ACSL5 inhibitor for the treatment of obesity and related cardiometabolic disorders. In November, we presented clinical in vivo efficacy data from two studies related to LX9851 at obesity week.

Speaker 2

The first study showed the treatment with LX9851 resulted in significant reductions in weight, food intake and fat mass in diet induced obese mice and that LX-nine thousand eight hundred and fifty one mitigated weight regain following discontinuation of the GLP-one analog semaglutide. The second study characterized the novel mechanism of action of LX-nine thousand eight hundred and fifty one and how it activates the ileal break to induce satiety and lower desire for additional food consumption. We remain on track for an IND submission to LX-nine thousand eight hundred and fifty one in 2025 as we evaluate potential partnership opportunities for this innovative mechanism. So now I want to briefly touch on the current status of sotagliflozin. We have a significant potential opportunity to expand our label in hypertrophic cardiomyopathy, a disease state with high unmet need that impacts about one million patients in The U.

Speaker 2

S. We're currently enrolling SONATA HCM, a global pivotal Phase three study, including patients with both obstructive and non obstructive HCM. Upon completion of the HCM study with additional evidence and data in hand, we will revisit the totality of the sotagliflozin asset potential in The U. S. In terms of what we're doing today though, as we bridge to this future opportunity, as you can recall, we made the necessary decision to cease all promotion of Impeper in The U.

Speaker 2

S. For heart failure due to the difficult market access environment dominated by two major SGLT2 inhibitors. Currently, sotagliflozin is available on The U. S. Market with our continued commitment to maintain awareness and provide tools to support patients in an extremely cost effective approach.

Speaker 2

Outside of The U. S. And Europe, we're actively working with our exclusive licensee, Beatrice on supporting their efforts towards registration and regional development. Our medical affairs, data generation and public patient activities remain ongoing and we continue to engage with the scientific community through numerous investigator initiated third party funded studies to build upon our compelling body of medical evidence in CV conditions and outcomes and support sotagliflozin as a differentiated inhibitor of both SDLT1 and two. Now to that end, I wanted to briefly acknowledge a notable recent publication in The Lancet Diabetes and Endocrinology, which highlighted the effects of sotagliflozin to reduce major adverse cardiovascular events or MACE, myocardial infarction and stroke among patients with Type two diabetes, chronic kidney disease and high cardiovascular risk.

Speaker 2

The findings show that sotagliflozin significantly and meaningfully reduces MACE versus placebo demonstrating early and broad cardiovascular protection in this population. This research also highlighted that sotagliflozin is the only SGLT inhibitor to show significant reductions in both MI and stroke, indicating the potential role of SGLT1 inhibition in reducing ischemic events, an important distinction from selective SGLT2 inhibitors. As I shared just a moment ago, this supports our goal of demonstrating differentiation of sotagliflozin and presents compelling additional support as Beatrice on regulatory submissions in key ex U. S. And ex European markets throughout 2025.

Speaker 2

I'll now turn it over to Scott to walk you through our financial results for the quarter and the year ended 12/31/2024.

Speaker 3

Thanks, Mike. Lexicon ended 2024 with $238,000,000 in cash, cash equivalents and short term investments as compared to $170,000,000 as of 12/31/2023. As noted in this afternoon's press release, we reported 26,600,000 in revenue in the fourth quarter and $31,100,000 in revenue for the full year 2024. Revenues for AMPEFA were $1,700,000 in the fourth quarter of twenty twenty four and $6,000,000 for the full year 2024. Total revenues for both the fourth quarter and full year include an upfront payment of $25,000,000 received in connection with the Viatris licensing agreement.

Speaker 3

Research and development expenses for the fourth quarter increased to $26,700,000 from $14,800,000 in the fourth quarter of twenty twenty three. Full year 2024 research and development expenses increased to $84,500,000 in 2023, primarily due to our investments in Phase II and Phase III clinical trials, including the SONATA Phase III study of sotagliflozin in HCM and the PROGRESS Phase IIb study of pilavapatin in DPNP. Selling, general and administrative expenses for the fourth quarter of twenty twenty four were of $32,300,000 were comparable to the $32,600,000 of SG and A expenses in the fourth quarter of twenty twenty three. Full year 2024 SG and A expenses increased to $143,100,000 from $114,000,000 in 2023. This increase in 2024 reflects higher marketing costs related to the commercialization of Mpefa and increased employee salaries and benefit costs prior to the reduction in our field sales force in late twenty twenty four as well as severance costs associated with our strategic repositioning.

Speaker 3

Net loss for the fourth quarter of twenty twenty four was $33,800,000 or $0.09 per share as compared to a net loss of $49,800,000 or $0.2 per share in the corresponding period in 2023. And net loss for the full year 2024 was $200,400,000 or $0.32 per share in 2024 as compared to a net loss of $177,100,000 or $0.8 per share for the same period in 2023. During 2024, Lexicon took steps to first reduce and then to eliminate all promotional efforts for Empefa. These included a significant reduction of employees and elimination of all promotional efforts for Empefa and heart failure in The U. S.

Speaker 3

We believe these steps will reduce operating expenses moving forward. For 2025, we expect total operating expenses to be in the range of $135,000,000 to $145,000,000 We expect research and development expenses to be in the range of $100,000,000 to $105,000,000 and G and A expenses to be in the range of $35,000,000 to $40,000,000 Research and development expenses include costs associated with the ongoing development of sotagliflozin for HCM, preparations for the Phase III development of pilavapatinin and preclinical costs associated with preparations for the IND filing of LX-nine 851. Research and development expenses for 2025 do not include the costs of pivotal Phase III trials for pilavapidin as the size and scope of these trials will be determined as part of our end of Phase two review discussions with the FDA. I'll now turn it back to Mike for closing remarks.

Speaker 2

Yes. Thanks, Scott. And look in summary, we've got a full and exciting year ahead. The work we did in 2024 really set the foundation and we look forward to updating you all as the year progresses. For pilavapatin, we've got a number of important upcoming catalysts including disclosure of the full progress dataset, the end of Phase two meeting with the FDA and data presentations at upcoming endocrinology and pain focused medical meetings.

Speaker 2

In addition to the important upcoming milestones we discussed today, we're also very actively engaged in partnership discussions that enhance our clinical and commercial capabilities and help us maximize the potential of all of our novel therapies. This will be critical focus for the company in the coming months. And so with that, Scott, Craig and I have time to take all of your questions. So I'll turn it back to you, operator.

Operator

Our first question comes from the line of Joseph Stringer from Needham and Co.

Speaker 4

Hi. Thanks for taking our questions. From us, I want to ask on the 09/1951 oral obesity asset and kind of the clinical development plan there. Couple of questions on that. Is that only being considered as a combo therapy with say a GLIF drug or is there an option for monotherapy?

Speaker 4

And then what are the potential indications and or trial designs that you're thinking of for an initial Phase one? And then lastly, if a decision is made to ultimately partner that program, how much clinical data do you think you need to generate before it would make sense to engage your turnover to a potential partner?

Speaker 5

So Joey, it's Craig. I'll answer the first two questions and probably turn it back over to Mike for the third. We really see this molecule as being developed both as monotherapy and combination therapy. Monotherapy alone or monotherapy after discontinuation of an injectable or other GLP-one agonist knowing with the data that's come in with the injectables at least that a vast majority of patients don't remain on therapy for more than a year. In fact, the median duration is somewhere between six and twelve months.

Speaker 5

So what we've demonstrated in the animal models is the activity of the drug is independent and additive on top of semaglutide, even maximum dose semaglutide. And if you withdraw the semaglutide and then add the nine thousand eight hundred and fifty one that you largely maintain the weight loss, whereas if you don't add the 9,851 weight returns very quickly to baseline, which is also the situation in patients. So we see that there's an opportunity in both mono and combination therapy. The second question on the clinical program, I think the Phase one program is going to be pretty standard. What we've communicated before is we have a few critical goals that would be a part of the Phase one clinical program.

Speaker 5

First and most importantly is, do patients actually lose weight similar to what we see in the animal models? The second is the tolerability of the therapy, because again, you always have to wonder in these treatments. The question is, will it be well tolerated, especially with the novel mechanism of action like the legal break. We haven't seen anything in the animal models to suggest that would be an issue with tolerability, but that would be an important component. And the third is to demonstrate that there would is a clear mechanistic differentiation from the GLP-one mechanism.

Speaker 5

So I think those would really be the three critical goals that we've certainly thought about in running the Phase one program. And I'll turn it back over to Mike for the last part of your question.

Speaker 2

Yes. Thanks for the question. And as you could imagine with a completely novel and orthogonal mechanism to the GLP-one and in creatinine based mechanisms, there's a number of companies that have not only been interested in this particular asset, but have engaged in the data over the last month. We've been talking to a number of players. And what it would take to move into a partnership from a data perspective is really quite varied.

Speaker 2

And we're prepared if we do have the right partner with the right conditions at any particular time to move into partnership because ultimately we believe that this program is best served with a partner to really capitalize on the breadth of indications, again with the potential for indications beyond obesity, as well as the commercialization of this particular mechanism ultimately. So that's where we're at with 09/1951 and potential partnering opportunities.

Speaker 4

Great. Thank you so much for taking our questions.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Yasmin Rahimi from Piper Sandler.

Speaker 6

Hi, this is Heena on for Yas. Thank you for taking our questions. My first question is, could you kindly provide some color on how enrollment is progressing into your SONATA study and when you expect enrollment completion? And with that, how soon could you engage with the FDA for the end of Phase two meetings for filivapidin and start planning for Phase three? And finally, what are some of the rate limiting steps to complete for the IND filing for 09/1951, which was previously discussed?

Speaker 6

Thank you.

Speaker 2

Right. Three great questions on three different programs.

Speaker 5

I'll let Craig have a stab at those. Thanks, Tina. I'll answer them in order. On the HCM program, we've been really pleased by the feedback we've gotten. We've had a number of investigator meetings both in The U.

Speaker 5

S. And outside The U. S. We focus first and initially on opening sites in The U. S.

Speaker 5

We've communicated that we're targeting about 30 sites in The United States, One Hundred And Twenty sites overall with a target enrollment of about 500 patients, two fifty each stratified for obstructive and non obstructive. I can say that we've made outstanding progress in getting all the government approvals necessary to have those conversations in countries outside The U. S. And we have sites open in non U. S.

Speaker 5

Countries right now. Again, we've not been forthcoming with exactly what those are, but we can say that we are opening sites on plan. We have patients that are actively in screening and actively in treatment today similar to the timelines we've set. The timelines I think we've talked about is that we're looking to have final study results towards the end of twenty twenty six, which means that we would be filing with the FDA probably sometime in the first quarter of twenty seven. Those are our current timelines.

Speaker 5

Obviously, it's early days in the trial, but those are the timelines that we've put forward and there's nothing at this point that we think is going to be significantly changing those timelines at the moment. So if that can answer your questions on HCM, I'll move forward to pilavapitan. For pilavapitan, we've communicate I'm sorry, I didn't mean to cut you off. For pilavapidin, we're really as Mike mentioned and I think we mentioned in the call on Monday, we're really looking to get down to the FDA and have the end of Phase two meeting sometime in the second half of this year with the possibility of starting Phase three program before the end of twenty twenty five. Obviously that will be dependent on a number of other factors, but those are the timelines that we feel comfortable at.

Speaker 5

And just to reiterate what Mike said is that we are more confident than ever in that ten milligram dose as being the right dose and that the progress study really clarified the open issues that we had going into the study about what is the best dose to go into Phase three, balancing both safety and efficacy and do you need the loading dose or not. So we feel quite strongly positive now to move to the end of Phase two, publish the data this year and then move into Phase three. On 09/1951, we've mentioned and I think Mike talked about that our plan is to have all of the IND enabling studies done this year to get down to the FDA and have that meeting and be ready to start the first in human studies before the end of the year. That's the timelines that we continue to track to. We're doing all of the IND enabling studies right now.

Speaker 5

We had to do the dose finding from the animal studies to do the final toxicology studies that are required as part of the standard IND package and we're working actively against those targets.

Speaker 6

Thank you so much.

Operator

Thank you. Thank you, Tina. One moment for our next question. Our next question comes from the line of Joe Pantginis from H. C.

Operator

Wainwright.

Speaker 7

Everybody, good afternoon. Thanks for taking the questions. Two questions, if you don't mind. So for pilavapidin data that you just put out, sort of a looking forward question. Craig, on the call earlier said some broad strokes as to what the Phase three program might look at look like.

Speaker 7

Can you discuss anything right now with regard to what you feel might be the key open questions absolutely change tomorrow?

Speaker 5

Yes. Joe, great question. I think we mentioned perhaps at least in passing on Monday, some of the critical things that we're going to look at as we get the final data set in.

Speaker 4

A couple

Speaker 5

of them we've really talked about some of the key secondary endpoints that we think are most meaningful to patients as Mike talked about is particularly sleep interruption and burning pain. So those are going to be important endpoints that we want to take a look at as we get the full data set in. Another one that we believe is pretty important to look at is the use of the acetaminophen rescue protocol, as you remember from relief that correlated really nicely with response that there was much greater and earlier use of the acetaminophen rescue in the placebo arm than in the active arm. And we feel comfortable that those three particularly are going to be important elements that will be consistent or hopefully consistent with the primary endpoint data that we shared and we're certainly consistent in the relief study. I think the other area that we have an interest and I know a number of people that have asked have interest is what was the response regardless of the underlying single DPNP medication use.

Speaker 5

And as a reminder in relief, we demonstrated activity independent

Speaker 2

from the

Speaker 5

underlying DPNP medication and on top of the DPNP medication. So I think that is going to be another important question because I think going into Phase three, if we could demonstrate we have activity both with or without underlying DPNP medication here. So I think that will be very important for patients, healthcare providers and payers to know. We'll also continue to look at some of the additional safety parameters in reference to DPMP use, Looking at that in some of the demographic factors as I think we mentioned, there were some notable differences in the demographics, particularly the representation of Black Americans in the trial was nearly double. So we will continue to look at some of those factors as well.

Speaker 5

Hope that wasn't too long a list, Joe.

Speaker 7

No, no, that's fantastic. I appreciate that color. And then just quickly, I guess, a financial logistical question, if you will. Just wanted to make sure have the Impefa one time charges work through the system already or should we expect any for the first quarter?

Speaker 3

Hey, Joe, it's Scott. No, I would say that it's safe assumption that all the costs were accrued certainly accrued as of the end of the year.

Speaker 7

Perfect. Thanks for all the color guys.

Speaker 2

Thanks Jeff.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andrew Tsai from Jefferies.

Speaker 8

Hey, thanks. Good afternoon. Appreciate all the updates. Maybe two questions on pain on my side. For the upcoming FDA and a Phase two meeting, could it make sense to ask them if this Phase 2b counts as a supporting pivotal?

Speaker 8

And by extension, do you have a base case or upside case internally? And then secondly, at this juncture, do you think you would be powering the Phase III 3s to what you saw in the Phase 2a or the Phase 2b for the ten mg dose? Thank you.

Speaker 5

Yes, Andrew, thanks for the question. Certainly, that would be an upside in our current scenario planning of having this trial be counted as a pivotal. We would see it counting strongly as a supportive trial, but our base assumption would not be that this was a pivotal trial. And I think as we've previously shared our current thinking, which obviously will be impacted by FDA is that we'd be looking at two pivotal trials going into the Phase three program, each one of which would have roughly 300 to 400 patients in size. And to your question, we would probably power it similarly that we powered both of these current trials for the statistics of a 0.6 drop on a placebo adjusted basis.

Speaker 5

And I wanted to reaffirm one of the points that Mike made in passing is that we demonstrated in the progress study that if the ten milligram dose, the pain scores continue to decline at a linear rate that was really consistent from week three on. So you saw a sharp drop in in the first couple of weeks and then the slope of the curve changed, but remained pretty consistent from week three or so to week eight. We don't see any reason why that would particularly mitigate between week eight and week twelve. And if you sort of straight line that out, we think that that pain score is going to continue to significantly drop. If you look at the placebo and what has traditionally been seen in pain studies with placebo is that that tends to plateau at somewhere between four and eight weeks.

Speaker 5

And you can already see hints of that in this trial and in the relief trial that the plateau that the placebo is beginning to plateau. So we feel quite confident or comfortable that that wedge, that growing wedge of difference from the placebo in pain score to the drug will continue to grow between week eight and week twelve and that 0.6 drop is something that we think is we can comfortably achieve.

Speaker 8

Thanks. Appreciate it.

Speaker 4

Thanks, Andrew.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Rowan Reis from Leerink Partners.

Speaker 9

Hi, all. This is Maisie on for Rowan. I just we just had two commercialization questions kind of around sotagliflozin and HCM. So for one, what are your thoughts around partnership and commercialization for that asset? And it's kind of a two parter.

Speaker 9

And the second part being, how does that differ across different regions where CMI use may be impacted in countries of in Africa and Asia? I think that we have seen that uses a lot less. And so just kind of wanted your insights around that, please. Thanks.

Speaker 2

No, great question. So firstly, for HCM ex U. S. And ex Europe, that is entirely licensed to VITRIS, our sotagliflozin partner. So in if you like rest of world, Viatris and we're closely connect with them to help them in the registration process, etcetera, for HCM as well as the other indications.

Speaker 2

For The U. S. And well for Europe, I think we've mentioned before, we don't have any intention in expanding our presence and certainly not our commercial presence outside of The U. S. So we would be seeking a partner for Europe where there is pretty substantial CMI use as you know.

Speaker 2

And then it comes to The U. S. And really we feel we've got the expertise and capabilities to commercialize HCM, sotagliflozin for HCM. And as we've mentioned before, it's going to be a very different payer situation for HCM as the first and only SGLT inhibitor approved for HCM to what we see for IMpefferin heart failure. And so that will provide us with a much different potential commercialization trajectory.

Speaker 2

Now, one interesting and final aspect to that commercialization approach is unlike the CMIs and I think this will continue both with currently approved and future approved CMIs that will be used in a pretty focused way in centers of excellence that treat HCM patients. General cardiology see HCM patients and are able to diagnose and the SDLT as a class is very well known by general cardiologists. And so really there's an opportunity, although we certainly see ourselves playing a significant role commercially in The U. S, there may be other partnering opportunities as we move forward, but we will hold a very significant if not sole approach to commercializing that in The U. S.

Speaker 9

Great. Okay. Thanks for the added color. Actually to follow-up on that then, as we think about the baseline characteristics for SANADA, are there any targets for the amount of patients that could be on background beta blocker or CMI therapy?

Speaker 5

Great question, Mason. We have not put limitations on any baseline or background therapy. We took a very similar approach to what we did with the SCORED and SOLOIST trials, where we included all patients with heart failure in those trials regardless of whether they were heparaph or hep pep. In this trial, we're taking all patients that remain symptomatic as defined by a baseline KCCQ score. So they can be on any underlying medication, including a CMI in that regard.

Speaker 5

And what we really care most about is that they have a adequately low KCCQ score at baseline. That's really the major criteria. As a reminder, also the ejection fraction that we allow is an EF down to 50%. So I think the opportunity to include both obstructive, non obstructive background therapies that exist including CMIs and an EF down to 50%, as well as having the primary endpoint as KCCQ. The secondary endpoint is New York Heart and no requirement for all of the echoes that the CMIs require that has all of the other physiologic testing, the peak VO2 and others that really make it very difficult to enroll those trials and limit the number of centers in those trials.

Speaker 5

We believe that our trial offers a number of different upsides in that regard.

Speaker 9

Very helpful. Thank you all for the added color.

Speaker 1

Yes. Thanks, Ben.

Operator

Thank you. At this time, I would now like to turn the conference back over to Mike Exton for closing remarks.

Speaker 2

Well, thanks everyone for joining us this afternoon. It was great to have you all here and give you a complete update across the three pretty significant programs that we have for sotagliflozin, for filabaptan and LA2951. We've got a busy quarter ahead of us and really look forward to updating you as we progress throughout the quarter and indeed throughout the year. So thank you very much operator and see everyone later.

Operator

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

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