Late-breaking presentation of analysis of SCORED clinical trial data describes significant reduction in cardiovascular death, myocardial infarction and stroke with sotagliflozin treatment as compared to placebo
The Woodlands, Texas, April 2, 2022 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced results of a new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin that was presented at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).
The SCORED clinical trial randomized 10,584 patients with type 2 diabetes and chronic kidney disease to sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, or placebo. Treatment with sotagliflozin resulted in a significant reduction in major adverse cardiovascular events (MACE) of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in the entire cohort as compared to placebo.
This analysis also evaluated the effect of sotagliflozin on MACE in prespecified subgroups of patients with cardiovascular disease (CVD; n=5,144) and without CVD (n=5,440) at baseline. The analysis showed consistent reductions in MACE in both subgroups with a relative risk reduction in MACE of 21% in patients with and 26% in patients without CVD, in each case compared to placebo.
“This analysis demonstrated that in addition to reducing heart failure events, sotagliflozin reduced MACE events,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and study chair for the SCORED trial. “The lower rates of MACE, notably including reductions in both heart attack and stroke, were consistent in patients with and without cardiovascular disease at baseline.”
“We continue to present results showing consistent benefits of sotagliflozin across a wide range of cardiovascular measures,” said Craig B. Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We remain focused on our goal of making sotagliflozin available for the millions of people suffering from heart failure.”
The presentation was entitled, “Sotagliflozin Significantly Reduces Cardiovascular Death, Myocardial Infarction, and Stroke in the SCORED Trial” and was presented as part of the Featured Clinical Research I session; the abstract is posted on the ACC website.
About the SCORED Study
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.
Key results from SCORED were previously presented on November 16, 2020, at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in an article titled: “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease” which may be accessed at www.nejm.org.
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, type 1 and type 2 diabetes, and chronic kidney disease in fourteen Phase 3 clinical studies involving approximately 20,000 patients.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, 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 safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin, LX9211 and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, successfully commercialize any products for which it obtains regulatory approval, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Executive Director, Corporate Communications and Investor Relations