Topline Results for Phase 2b PROGRESS Study of Pilavapadin (LX9211) in Diabetic Peripheral Neuropathic Pain (DPNP); 10 mg dose to Advance into Phase 3 Development Leaner organization focused on Advancing Strong Pipeline Conference Call and Webcast at 5:00 pm ET THE WOODLANDS, Texas, March 06, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and year ended December 31, 2024, and provided an update on key corporate milestones and acc ...

THE WOODLANDS, Texas, March 04, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will release its fourth quarter and full year 2024 financial results on Thursday, March 6, 2025 after the markets close. Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update. Participants can access the conference call live via webcast on the Events page of the Company’ ...

Pilavapadin achieved meaningful pain reduction versus placebo and was well-tolerated in the 10 mg dose, meeting the Company’s objectives for the study Advancement of 10 mg dose into Phase 3 development in DPNP supported by both PROGRESS and RELIEF DPN-1 studies, which collectively enrolled approximately 600 pilavapadin-treated patients Conference call and webcast at 8:00 a.m. ET THE WOODLANDS, Texas, March 03, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced topline resu ...

Core Insights - Lexicon Pharmaceuticals announced a conference call and webcast to share topline results from the Phase 2b PROGRESS study evaluating pilavapadin (LX9211) for diabetic peripheral neuropathic pain (DPNP) [1][2] Group 1: PROGRESS Study Details - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe DPNP [3] - The study was placebo-controlled, with the primary endpoint being the change from baseline to Week 8 in the Average Daily Pain Score (ADPS) compared to placebo [3] - Three treatment groups received once-daily doses of pilavapadin: 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg thereafter [3] - Secondary endpoints included changes in burning pain and pain interference on sleep from baseline to Week 8 [3] - Patients were allowed to remain on stable-dose DPNP therapies, aligning with practical usage of new DPNP drugs [3] Group 2: Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes characterized by burning pain, numbness, and other symptoms in extremities [4] - Approximately 9 million patients in the U.S. suffer from DPNP [4] Group 3: Pilavapadin Overview - Pilavapadin (LX9211) is an investigational AAK1 inhibitor, designed to be a potent, once-daily, orally delivered small molecule [5] - It targets neuropathic pain by inhibiting neurotransmitter reuptake and recycling without affecting opiate pathways [5] - Preclinical studies indicated that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [5] Group 4: Company Background - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives through its Genome5000™ program [6] - The company has identified over 100 protein targets with therapeutic potential across various diseases [6] - Lexicon has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development, including heart failure, neuropathic pain, obesity, and diabetes [6]

Core Insights - The study published in The Lancet Diabetes & Endocrinology highlights the clinical advantages of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing life-threatening cardiovascular outcomes compared to empagliflozin [2][3] - Sotagliflozin demonstrated a significant reduction in major adverse cardiovascular events (MACE), myocardial infarction (MI), and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular risk [3][5] Study Findings - The secondary analysis of the SCORED trial revealed that patients receiving sotagliflozin had a lower rate of MACE outcomes at 4.8 events per 100 person-years compared to 6.3 events per 100 person-years in the placebo group, with a hazard ratio of 0.77 [4][5] - The study also found that sotagliflozin reduced the rate of MI to 1.8 events per 100 person-years versus 2.7 events per 100 person-years in the placebo group, with a hazard ratio of 0.68 [5] - Additionally, the rate of stroke was reduced to 1.2 events per 100 person-years in the sotagliflozin group compared to 1.8 events per 100 person-years in the placebo group, with a hazard ratio of 0.66 [5] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to discover therapeutic targets [9] - The company has a pipeline of drug candidates in various stages of development, addressing conditions such as neuropathic pain, hypertrophic cardiomyopathy, and obesity [9]

Core Insights - The article highlights the unique clinical advantages of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing life-threatening cardiovascular outcomes compared to empagliflozin [2][3] - A published study in The Lancet Diabetes & Endocrinology confirms the ischemic benefits of sotagliflozin, showing significant reductions in major adverse cardiovascular events (MACE), myocardial infarction (MI), and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular risk [3][5] Study Findings - The study titled "Reduction in Major Adverse Cardiovascular Events with Sotagliflozin" is a secondary analysis of the SCORED trial, which was a double-blind, placebo-controlled, randomized clinical trial [4] - Sotagliflozin demonstrated a lower rate of MACE outcomes at 4.8 events per 100 person-years compared to 6.3 events per 100 person-years in the placebo group, with a hazard ratio of 0.77 [5] - The reduction in MI was significant, with 1.8 events per 100 person-years in the sotagliflozin group versus 2.7 events per 100 person-years in the placebo group, yielding a hazard ratio of 0.68 [5] - Stroke rates were also lower in the sotagliflozin group at 1.2 events per 100 person-years compared to 1.8 events per 100 person-years in the placebo group, with a hazard ratio of 0.66 [5] Expert Commentary - Dr. Deepak L. Bhatt emphasized that sotagliflozin is the only SGLT inhibitor to show significant reductions in both heart attack and stroke [6] - Craig Granowitz, M.D., noted that the comprehensive findings illustrate how sotagliflozin stands apart from other SGLT inhibitors [7] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to discover therapeutic targets [9] - The company has a pipeline of drug candidates in various stages of development, addressing conditions such as neuropathic pain, hypertrophic cardiomyopathy, and obesity [9]

Core Insights - Lexicon Pharmaceuticals is hosting a virtual webcast titled "LX9211 - Changing the Paradigm for Treatment of Neuropathic Pain" on January 28, 2025, from 9:00 a.m. to 11:00 a.m. ET [1] - The event will provide an in-depth overview of LX9211, a novel non-opioid treatment for diabetic peripheral neuropathic pain (DPNP), ahead of the anticipated topline data from the Phase 2b PROGRESS trial [2] - The webcast will feature presentations from Lexicon leadership and an expert panel, along with a Q&A session focused on DPNP [2] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company dedicated to pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [3] - The company has a pipeline of promising drug candidates in various stages of discovery and development, targeting indications such as cardiology, neuropathic pain, and metabolism [3]

Core Insights - Lexicon Pharmaceuticals received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) [4] - The company has decided to discontinue launch preparations for Zynquista and will focus on its clinical development pipeline [2] - Lexicon is committed to advancing its clinical pipeline, particularly LX9211 for diabetic neuropathic pain (DPNP), with top line data from the PROGRESS Phase 2b study expected in Q1 2025 [6] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has a pipeline of promising drug candidates in various stages of development, targeting conditions such as neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, and metabolism [5]

Core Insights - Lexicon Pharmaceuticals has successfully completed patient enrollment in the PROGRESS study, exceeding the target by 20% with a total of 494 patients enrolled, and finishing eight weeks ahead of schedule [2][3][4] - Top-line data from the PROGRESS study is expected to be announced in Q1 2025, which will provide critical insights for the Phase 3 design of LX9211 [3][4] Study Details - The PROGRESS study is a Phase 2b trial evaluating LX9211 for diabetic peripheral neuropathic pain (DPNP), a condition with significant unmet treatment needs [2][5] - The primary endpoint of the study is the reduction of Average Daily Pain Score (ADPS) at 8 weeks, with secondary endpoints including changes in burning pain and pain interference with sleep [5] - The study design allows patients to maintain one stable-dose DPNP therapy, aligning with real-world treatment practices [5] Background on DPNP - Diabetic peripheral neuropathic pain (DPNP) affects approximately 5 million patients in the U.S., resulting from nerve damage due to chronically high blood sugar levels [6] - DPNP can lead to debilitating symptoms such as pain and numbness in extremities, highlighting the urgent need for new non-opioid treatment options [6][4] About LX9211 - LX9211 is a novel, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1), identified through Lexicon's gene science approach [7] - Preclinical studies have shown that LX9211 can penetrate the central nervous system and reduce pain behavior without affecting opiate pathways [7] - The drug has received Fast Track designation from the U.S. FDA for development in DPNP [7] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [8] - The company has a pipeline of drug candidates in various stages of development for conditions including neuropathic pain, hypertrophic cardiomyopathy, and obesity [8]

Group 1 - Lexicon Pharmaceuticals will present at two investor conferences in December 2024, including the Piper Sandler 36th Annual Healthcare Conference on December 3 and the 7th Annual Evercore HealthCONx Conference on December 5 [1] - The presentations will be available via simultaneous webcasts on Lexicon's website, with recordings accessible for two weeks post-event [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The company utilizes its Genome5000™ program to study nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential across various diseases [2] - Lexicon has a pipeline of drug candidates in discovery and clinical development targeting neuropathic pain, hypertrophic cardiomyopathy, obesity, metabolism, and other indications [2]