Clinical Data Demonstrating Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure (HFpEF) without Diabetes Presented at American Heart Association (AHA) Annual Scientific Sessions 2025

Core Insights - Lexicon Pharmaceuticals presented new clinical data on sotagliflozin at the AHA Annual Scientific Sessions 2025, highlighting its benefits for heart failure patients with preserved ejection fraction (HFpEF) [1][5] - The study demonstrated significant improvements in cardiac structure, function, quality of life, and functional capacity for HFpEF patients without diabetes [4][5] Study Details - The "SOTA P CARDIA" trial was a randomized, double-blind, placebo-controlled study directed by Dr. Juan J Badimon, focusing exclusively on HFpEF patients [2] - The study enrolled 88 diverse participants, with 70% being female, and compared the effects of sotagliflozin against a placebo over six months [3] Key Findings - Treatment with sotagliflozin resulted in statistically significant improvements in left ventricular mass, diastolic function, six-minute walk test capacity, and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores [4] - Although peak VO2 improvement was not statistically significant, there was a notable enhancement observed post-treatment [4] Broader Implications - The findings suggest that sotagliflozin may represent a new class of medication for HFpEF patients, particularly given its potential to reduce risks for major adverse cardiovascular events (MACE) and rehospitalization [6] - Approximately 6.7 million Americans suffer from heart failure, with over half having preserved ejection fraction, indicating a significant patient population that could benefit from sotagliflozin [5] About Sotagliflozin - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1, involved in glucose regulation, and has been studied in various patient populations, including those with heart failure, diabetes, and chronic kidney disease [7] - The drug is also under investigation for hypertrophic cardiomyopathy (HCM) [7] Company Overview - Lexicon Pharmaceuticals aims to pioneer transformative medicines through its Genome5000™ program, focusing on genomics and the discovery of therapeutic protein targets [8] - The company has a pipeline of drug candidates in various stages of development, targeting conditions such as neuropathic pain, HCM, obesity, and metabolism [9]