Benzinga | Aug 23, 2021 06:10AM EDT

Lexicon's Sotagliflozin Demonstrates Additional Compelling Benefits in Reducing Cardiovascular Endpoints: Results from Soloist and Scored Trials

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today presented additional analyses of sotagliflozin data from the SOLOIST and SCORED Phase 3 clinical trials at ESC Congress 2021 - The Digital Experience. Sotagliflozin is a first-in-class, investigational dual SGLT1 and SGLT2 inhibitor that showed substantial reductions, compared to placebo, in the primary endpoint of total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure in both studies in patients with type 2 diabetes and worsening heart failure or chronic kidney disease.

"Based on analyses of the SOLOIST and SCORED trials, sotagliflozin robustly and significantly reduced heart failure hospitalizations, myocardial infarction and stroke," said Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital; Professor of Medicine, Harvard Medical School, Boston, MA, USA; Study Chair of the SOLOIST and SCORED clinical trials. "Sotagliflozin also showed rapid and broad benefit across multiple cardiovascular endpoints. Although direct, head-to-head clinical comparisons have not been performed, the reductions in both MI and stroke observed with sotagliflozin appear greater than what has been published in meta-analyses of clinical data from selective SGLT2 inhibitors."

Dr. Bhatt presented these new findings in a virtual podium presentation entitled, "Benefits of SGLT2-1/2 Inhibition on Heart Failure, Ischemic, and Kidney Endpoints." The new analyses evaluated the effect of titrating sotagliflozin from the initial daily dose of 200 mg to 400 mg on the primary endpoint (a composite endpoint of cardiovascular death, heart failure hospitalizations and urgent visits for heart failure) and other cardiorenal endpoints from the SOLOIST and SCORED trials. Approximately 73% of patients titrated to sotagliflozin 400 mg during the studies. Reductions in heart failure-related events were more pronounced at the target daily dose of sotagliflozin 400 mg, whereas similar results were observed between sotagliflozin 200 and 400 mg with other endpoints.

"The SOLOIST and SCORED trials continue to show compelling efficacy of sotagliflozin across the full spectrum of heart failure in the type 2 diabetes population, with potential for rapid, broad and substantial benefit," said Dr. Gabriel Steg, Professor of Cardiology, Universit? de Paris, and Chief, Department of Cardiology at the H?pital Bichat, Paris, France; Co-chair for the SCORED clinical trial. "Sotagliflozin is the only agent studied to date that has shown benefit in acute heart failure patients with therapy started following initial treatment or hospitalization for heart failure. The study data illustrate the value of sotagliflozin as a potential new treatment option for heart failure patients with type 2 diabetes."

"Presentation of these new data is another milestone as we prepare to submit a New Drug Application with the U.S. Food and Drug Administration later this year for sotagliflozin, as a therapy for people suffering from heart failure and living with type 2 diabetes," said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer at Lexicon. "As a dual SGLT1/SGLT2 inhibitor, sotagliflozin has demonstrated potentially differentiating benefits for patients with type 2 diabetes in need of safe and effective treatment options for acute or chronic heart failure, regardless of their left ventricular ejection fraction."