Press release
Lexicon to Present Phase 3 Trial Design for Sotagliflozin in Hypertrophic Cardiomyopathy (HCM) at Upcoming Medical Congress
Patient randomization is underway in SONATA-HCM clinical trial evaluating Lexicon’s novel dual SGLT1 and SGLT2 inhibitor in this underserved and growing
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Patient randomization is underway in SONATA-HCM clinical trial evaluating Lexicon’s novel dual SGLT1 and SGLT2 inhibitor in this underserved and growing patient population Study design intended to enable supplemental new drug application (sNDA) with a broad label in both obstructive and non-obstructive HCM THE WOODLANDS, Texas, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it will unveil study design details of SONATA-HCM, the company’s Phase 3 clinical trial of sotagliflozin as a potential new treatment for adults with hypertrophic cardiomyopathy (HCM), at the virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions. Lexicon plans to conduct the multinational study at 130 sites in 20 countries and enroll adults aged 18 years or older diagnosed with symptomatic HCM, either obstructive (oHCM) or non-obstructive (nHCM). Initial study sites have been activated and patient randomization is underway. Details for the presentation on “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” is as follows: HCMS (virtual) – a moderated poster presentation, Friday, September 27, 2:00-2:30p.m. ET, presented by Carolyn Y. Ho, M.D., Cardiology, Brigham and Women’s Hospital, Boston, MA The estimated prevalence of HCM in the United States is about 1.1 million. The most common patient-reported symptoms include shortness of breath, lightheadedness or dizziness, fatigue, heart fluttering or palpitations, and limitations to physical activities. “SONATA-HCM will evaluate the efficacy of sotagliflozin, a dual SGLT2 and SGLT1 inhibitor, on symptoms, function, and other patient-reported outcomes, as well as safety in patients with symptomatic HCM,” said Dr. Ho, M.D., Cardiology, Brigham and Women’s Hospital, and a co-author of the study abstract. “Despite recent advances in the treatment of HCM, there remain significant needs among patients and clinicians for new therapeutic options,” said Sharlene M. Day, M.D., Director, Translational Research, Division of Cardiovascular Medicine and Cardiovascular Institute, Presidential Associate Professor, University of Pennsylvania Medicine, and a co-auth...