Okay. Hello, everyone. Thank you for joining the H.C. Wainwright 26th Annual Global Investment Conference. My name is Vivian Chang, and I'm an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts with over 650 companies covered across all sectors. If you would like more information, please visit hcwco.com. From a logistics standpoint, please make sure to reference your online conference portal that provides your individual links to your meetings and all presentations. With that being said, we wish you a productive and enjoyable couple of days. Now, I will hand it off to Mike Exton, the Chief Executive Officer of Lexicon Pharmaceuticals.
Great. Thanks so much, Vivian, and while I introduce my team here up the front with me, I'll let you read the safe harbor. It's my pleasure to present to you here in the room and online. Here with me at the presenters table, if you like, is Tom Garner, our Chief Commercial Officer, Craig Granowitz, our Chief Medical Officer, and I'd like to take you through the reasons why 2024 is a really pivotal and somewhat transformational year for Lexicon Pharmaceuticals. Before I do that, just allow me to give a little bit of background about the company for those who are uninitiated with Lexicon. Actually, the company was formed nearly thirty years ago, right around the time the human genome was being described, and the company was formed to really take advantage of that situation.
What it did was identify 5,000 druggable genes and developed mouse models, knockout mouse models, to knock out and run a battery of about 50 tests across those 5,000 knockout models. In fact, what fell out of that is about 200 protein targets that looked promising from a pharmaceutical development perspective. Over time, Lexicon has now had two approved medicines by the FDA, and it's really in 2024 that the company is going to capitalize on its drug development profile. In fact, this year is pivotal for the company because we have recently resubmitted sotagliflozin Zynquista for glycemic management in type one diabetes with chronic kidney disease. We have an AdCom coming up on the thirty-first of October, with a PDUFA date set for December 20, 2024. That will be the second approved indication for sotagliflozin.
In addition, this year, we undertook the phase 3 SONATA study of sotagliflozin in hypertrophic cardiomyopathy. That's open, with sites enrolling and patients enrolling in that particular trial, which will be the third indication for sotagliflozin in our hands. Then importantly, we have the enrollment of our phase 2b study, PROGRESS-2B, of LX9211 in diabetic peripheral neuropathic pain, which is on target for reading out top-line data in the first half of 2025. In addition, LX9851, an oral drug candidate for obesity and weight management, is currently undergoing pre-IND studies with the target of submitting the IND this time next year, midway through next year.
In addition to all of these things, over the last six weeks, we've undertaken a strategic assessment of our, of our projects and decided that we would lean into what we're calling a Lead to Succeed strategy, where we're focusing on high-value projects and conserving about $40 million in operating expenses next year. So what does this Lead to Succeed strategy look like? We are doubling down in therapeutic areas where we are either first or best-in-class, and in fact, oftentimes the only asset that is in that particular therapeutic landscape. We're addressing large markets with a significant unmet need. We are in cardiometabolic and neuroscience disorders, and thereby are in retail-based disorders, but in indications that really allow us a focused commercial and medical presence that allows us to drive commercial value with a very focused commercial footprint.
By doing that, we believe that we're driving value for Lexicon across all stakeholders, physicians, payers, patients, and obviously shareholders. What the Lead to Succeed strategy is doing for this year is refocusing resources for Lexicon, where we have the potential to lead and succeed in those particular indications, where we will be the first and only therapy in those indications.
And what that means practically for us is focusing our near-term effort on Zynquista for type one diabetes and look forward in the presentation to describing to you our progress there, while at the same time continuing our promotion of INPEFA for heart failure and focus really on prescribers who currently have experience with INPEFA so that we can double down on their ability to understand the profile of the drug and get further experience using sotagliflozin in heart failure. Importantly, at the same time, we're fully investing across our R&D programs. As mentioned, our pivotal phase 3 study in HCM is ongoing. The 2B study is on track to read out next year, and of course, submitting an IND for LX9851 in obesity and weight management in 2025.
So you'll notice across our pipeline that all of these medicines are simple oral medications that have the potential to be a pipeline in a pill. And what do we mean by that? Well, we can just demonstrate it using sotagliflozin. As we mentioned, INPEFA was approved last year by the FDA. The particular marketplace has two SGLT2 alternatives within the market basket, and that provides a somewhat challenging context for us as a company to both contract and pull through commercially, INPEFA for heart failure. In contrast, though, for Zynquista in Type 1 diabetes for glycemic management, we have the ability to promote Zynquista should we get a favorable approval on December twentieth this year, where there are no other medicines approved as an adjunct to insulin. So clearly offering white space for us to really drive value for the asset.
In addition, to those two indications, we're currently investigating sotagliflozin for hypertrophic cardiomyopathy, which is obviously another significant opportunity for us in the cardiovascular space. So across this particular medicine, three separate focused indications that are going to drive value for the company moving forward. Let's take a look at Zynquista, because this is a really important near-term opportunity for us, 'cause it really addresses a significant treatment gap. You know, in Type 1 diabetes, there's a huge unmet need for adjunctive glycemic control in Type 1 diabetes. There's about 400,000 addressable patients in the U.S. alone, who have Type 1 diabetes and chronic kidney disease.
This has the potential to be the only SGLT inhibitor approved for the treatment of Type 1 diabetes with chronic kidney disease for glycemic control, and is really prescribed by a very focused group of prescribers, mostly endocrinologists. Why is this medicine so important in Type 1 diabetes? In fact, the FDA has indicated across a number of AdComs recently that in Type 1 diabetes, glycemic control is not completed well enough. Type 1 diabetes patients have difficulty maintaining time in range and overall glycemic control. Now, that is particularly important in those patients that have chronic kidney disease concomitantly with Type 1 diabetes. Why is that? 'Cause they're already marching down the path towards end-stage disease, renal failure, cardiac complications such as stroke and MI, retinopathy.
These are all problems that these patients are marching towards, and maintaining glycemic control, in particular, time in range, is critically important to these patients. And in fact, that's what the FDA requested of the company back in twenty nineteen when they issued the complete response letter for sotagliflozin, is identify a group of patients for whom glycemic control is critically important. Either that or show that you can reduce, the risk of diabetic ketoacidosis. So the company now, in the ensuing five years, together with a wealth of data from independent sources, has shown that tight glycemic control is critically important for these patients, and the benefit for those patients of sotagliflozin is increased compared to the normal Type 1 diabetes population.
We feel very confident now going to the AdCom at the end of this year and being able to demonstrate the value of sotagliflozin publicly for patients with T1D and CKD. Moving on now to hypertrophic cardiomyopathy. Again, this is an area of high unmet need, where sotagliflozin has the potential to be the first and only in the therapeutic treatment pathway for hypertrophic cardiomyopathy. This is the very pragmatic SONATA phase 3 study design, where we're comparing sotagliflozin with placebo across both obstructive and non-obstructive hypertrophic cardiomyopathy. As you know, the current myosin inhibitors currently are only indicated for obstructive hypertrophic cardiomyopathy. This is a very pragmatic design, where using sotagliflozin with an endpoint of KCCQ improvement, the FDA has indicated that it's sufficient for an approval in HCM.
That's important because in hypertrophic cardiomyopathy, the basal therapies, beta blockers and calcium channel blockers, are really not good enough. On the other end, you have myosin inhibitors that are significantly laborious for the institution to initiate. They involve a lot of effort, and the REMS program means that that particular patient has a lot of logistics involved in getting them initiated. Sotagliflozin offers a simple, once-a-day medicine for hypertrophic cardiomyopathy with a very safe side effect profile. We see this as another white space for the company in sotagliflozin.... Moving on now to LX9211, which is our second pipeline in a pill, which really has the potential to redefine the standard of care, not only for neuropathic pain, but also spasticity.
Again, this is really an area of underdevelopment and under innovation over the last twenty years, and we've shown with proof of concept studies that LX9211 has a significant effect on neuropathic pain, in particular, diabetic peripheral neuropathic pain. But in addition to that, is relevant across a number of neuropathic pain indications, and in addition, also MS-related spasticity and other spasticity models. So again, we have another opportunity where one of our medicines has potentially multiple indications moving forward. The PROGRESS-2B phase 2b study is really recruiting extremely well. It's currently ahead of our target, but looking good for a readout in the second quarter of twenty twenty-five.
And this is an important study because it's comparing doses of LX9211 versus placebo in patients with either Type 1 or Type 2 diabetic patients on top of their standard of care. They're either allowed to take gabapentin, pregabalin, duloxetine, and this placebo-controlled study is really differentiated versus really the only other neuropathic pain program that's currently being conducted. And this is important because using our study and a placebo-controlled design, we are showing significant improvements in pain score over and above standard of care. So it's a very pragmatic design that meets the patients where they are, meets the physicians where they are. Importantly, other programs have not used a placebo-controlled trial. They've just compared themselves with pregabalin and shown non-inferiority to pregabalin in their phase II studies.
Now, both from a payer perspective as well as from a physician perspective, I don't see that that necessarily adds significant value compared to a medicine that can be used on top of standard of care and really show significant reductions in neuropathic pain scores. So we're really excited to see this readout in the first half of next year. We believe that this has the potential to completely change the way neuropathic pain is treated and offer significant advantage versus both current standard of care, as well as future medicines being developed. And so finally, LX9851 is another target, another asset to a target that has been discovered using the Genome 5000 platform, and is now a first-in-class medicine against ACSL5, which is a completely novel target to manage obesity and other forms of weight management.
This is a medicine that shows benefit on top of incretins. It's an incretin-independent mechanism. It's again an oral medicine that avoids the injectable approach currently mostly used with GLP-1s. And we've seen fantastic reductions in weight both in many animal models and in addition a number of other cardiometabolic parameters. And so importantly what we see here is not only a reduction in overall body mass but we're seeing signs of a protection of lean body mass with this particular medicine, and as we said, is effective both alone and on top of the current GLP-1s. And so this offers an amazing approach either as a potential maintenance therapy as we look at the dropout rates that are currently seen with injectable GLP-1s and/or a potential complementary therapy for increased efficacy in weight management.
And so overall, what you've seen in the presentation today is that, you know, Lexicon is really poised for great success, both in this year and for next year, with the Lead to Succeed strategy across a pretty significant portfolio of medicines, both late stage and in early development, that offer potential for a number of different therapeutic areas. Sotagliflozin has three potential indications. LX9211 is progressing extremely well with the potential for a raft of indications in neuropathic pain and spasticity. And of course, we're very excited about LX9851 and the potential for that medicine in the burgeoning weight loss, weight management category. So very exciting things coming up for the company. So much so that in the near term, we have a number of pretty important catalysts for the company.
For Zynquista, for glycemic management in Type 1 diabetes with chronic kidney disease. As I mentioned, we've got a PDUFA goal date of December 20, with the AdCom taking place October 31. We're incredibly confident, with not only the patient population that we've selected, for this treatment, but also the additional data that we will have the opportunity to present, to the FDA and publicly demonstrating the benefit-risk of sotagliflozin in Type 1 diabetes. In HCM, the phase 3 study is open, and that offers another significant opportunity for that particular medicine.
9211 , we, as mentioned, will have the readout in the first half of next year, and we see that as a significant partnership opportunity, both to really expand the indications that we have for this particular medicine, but in addition to that, preparing for a commercial launch. And finally, with 9851 , by middle of next year, we will have completed IND-enabling studies and filed the IND. So hopefully, I've been able to demonstrate to you a significant portfolio for Lexicon, a period of time over the next six to nine months that will be transformational for the company, for stakeholders, and for patients, alike. So, appreciate your attention and happy to take questions.