Lexicon Pharmaceuticals, Inc.

Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter Company seeks alignment on reasonable path forward for Zynquista NDA resubmission FDA feedback from Type D meeting expected by end of September Sept. 08, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the Company has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D). The submission of additional clinical data follows a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1)1, the Joslin Diabetes Center (SUGARNSALT)2 and the University of Dundee (SOPHIST)3 supporting the benefit-risk profile of Zynquista in T1D. “There has been an outpouring of patient support advocating for the approval of Zynquista in T1D,” said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon Pharmaceuticals. “While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering.” Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. References 1“Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes (Steno1).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06082063. Accessed 4 Sept. 2025. 2“Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (SUGARNSALT).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06217302. Accessed 4 Sept 2025. 3“SOPHIST Clinical Trial.” University of Dundee, www.sites.dundee.ac.uk/sophist-trial/. Accessed 4 Sept. 2025. Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. The content above comes from the network. if any infringement, please contact us to modify.

Sept. 03, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced data from a study of patients describing the physical and psychological impact of diabetic peripheral neuropathic pain (DPNP), despite treatment with available over-the-counter and prescription pain relievers will be presented at PAINWeek 2025. The conference is being held September 2-4, 2025, at The Cosmopolitan in Las Vegas, Nevada. Poster #53: Listening to Patients with Diabetic Peripheral Neuropathic Pain: Insights from a Patient Survey to Inform Advanced Clinical Development of Pilavapadin Date: September 4, 2025 Time: 4:00 p.m. – 5:30 p.m. PST Location: Exhibit Hall (Level 4) Presenters: Belinda Hardin, PharmD, BCPS, Senior Director, Medical Communications, and Suma Gopinathan, M.S, Ph.D., Senior Vice President, Discovery, Lexicon Pharmaceuticals Diabetic neuropathy is a major complication affecting individuals with both type 1 and type 2 diabetes, with nearly half of all patients experiencing it during their lifetime. Among these patients, approximately 25-30% suffer from DPNP, characterized by burning, tingling, numbness and other symptoms. These symptoms can significantly diminish quality of life, leading to challenges in daily functioning and well-being. Timely diagnosis and effective management of DPNP remain crucial to alleviating the burden on affected individuals. Discovered using Lexicon’s unique approach to gene science, pilavapadin is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1, a novel target for neuropathic pain which inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Pilavapadin has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain (DPNP). Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. The content above comes from the network.if any infringement, please contact us to modify.

Sept. 02, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that a post-hoc analysis (“Efficacy of Sotagliflozin Among Older Adults: A Pooled Analysis of SCORED and SOLOIST-WHF”) of clinical data was presented Sunday, August 31, during an oral presentation at the European Society of Cardiology (ESC) 2025 Congress in Madrid, Spain. It is well-established that the incidence of stroke and myocardial infarction (MI, or heart attack), known collectively as major cardiovascular adverse events (MACE), rises with age, as does incidence of heart failure (HF) events. Sotagliflozin, a dual sodium-glucose cotransport 1 and 2 (SGLT-1 and SGLT-2) inhibitor, was approved by the FDA based on its demonstrated efficacy in improving HF endpoints in patients with chronic kidney disease (CKD) or HF. This latest Lexicon-funded analysis examined how the efficacy of sotagliflozin varies with age, particularly among older adults, and used data pooled from the two previous pivotal Phase 3 studies of sotagliflozin, SCORED and SOLOIST-WHF. The robust data set included nearly 12,000 participants, about 70% of whom were 65 or older. This age group represents a very large population in which type 2 diabetes, CKD and/or worsening HF are relatively common. Patients were evaluated by age, both categorically (≥65 years vs “Among patients with type 2 diabetes and either chronic kidney disease or heart failure, the addition of sotagliflozin reduced heart failure endpoints and major adverse cardiovascular events, irrespective of age,” said Rahul Aggarwal, MD, Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, lead study author and presenter of the oral presentation at ESC 2025. "Our team noted meaningful benefit in older adults, including those over the age of 65 and 75 years, who are often at the highest risk for cardiovascular events.” “The findings are unique to sotagliflozin among SGLT inhibitors and demonstrate that people of all ages, including elderly patients, can benefit when sotagliflozin is included in their treatment regimen,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer. “Future research could focus on benefits from sotagliflozin treatment in heart failure patients with preserved ejection fraction, or HFpEF, a population that is generally older and includes more women than other conditions.” The pooled analysis of SCORED and SOLOIST-WHF included a total of 5,900 (50.0%) and 5,906 (50.0%) patients were in the sotagliflozin and placebo groups, respectively. The median age of such patients was 69 years (interquartile range: 63, 74 years), with 3,588 (30.4%) and 8,218 (69.6%) patients Compared to placebo, sotagliflozin reduced the rate of the primary endpoint (total CV death and hospitalization or urgent visit for HF) overall (8.5 vs 11.8 events/100 person-years [p-y]; hazard ratio [HR]: 0.72), among adults Sotagliflozin similarly reduced total MACE compared with placebo (5.7 vs 7.1 events/100 p-y; HR: 0.80), with consistent findings among adults Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM). Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.  The content above comes from the network. if any infringement, please contact us to modify.