Published Data in The Lancet Diabetes & Endocrinology Highlights Unique Efficacy Benefits of Sotagliflozin to Reduce Major Adverse Cardiovascular Events (MACE)

Data reinforce unique clinical advantages of sotagliflozin

Published study is aligned with research presented in December 2024 at the American Society of Hematology showing clinical benefits of sotagliflozin compared to empagliflozin

THE WOODLANDS, Texas, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced The Lancet Diabetes & Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardiovascular outcomes. 

The findings from the study, “Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” concluded that the ischemic benefit of sotagliflozin on both heart attack (myocardial infarction, or MI), and stroke reduction has not been shown by other SGLT inhibitors. The researchers note that sotagliflozin reduced major adverse cardiovascular events (MACE), MI, and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular (CV) risk.

The study was a secondary analysis of SCORED, a double-blind, placebo-controlled, randomized clinical trial enrolling patients with T2D and CKD. A pre-specified outcome was total MACE, which was defined as a composite of total CV death, nonfatal MI, and nonfatal stroke. Other outcomes included total MI and total stroke.

Patients in the sotagliflozin group had a lower rate of MACE outcomes (4.8 events per 100 person-years [p-y]) compared with the placebo group (6.3 events per 100 p-y) (hazard ratio [HR]: 0.77; 95% confidence interval [CI]: 0.65-0.91; P=0.002). MACE benefit was consistent across pre-specified subgroups. Additionally, sotagliflozin reduced the rate of MI (1.8 events per 100 p-y) compared with the placebo group (2.7 events per 100 p-y) (HR: 0.68; 95% CI: 0.52-0.89; P=0.004) and of stroke (1.2 events per 100 p-y vs 1.8 events per 100 p-y) (HR: 0.66, 95% CI: 0.48-0.91, P=0.012).

“Our research team found that sotagliflozin is the only SGLT inhibitor to demonstrate significant reduction of both heart attack and stroke,” said Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, Director, of the Mount Sinai Fuster Heart Hospital, and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. The Icahn School of Medicine receives research funding for Dr. Bhatt’s role as the Chair of SCORED.

“When you look at the published and presented findings holistically, you get a clear picture of how and why sotagliflozin stands apart from all other SGLT inhibitors,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.

Click  to access the study abstract published by The Lancet Diabetes & Endocrinology on February 14, 2025.

About Sotagliflozin

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.

About Lexicon Pharmaceuticals   

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.  For additional information, please visit .   

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to sotagliflozin and Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery, development and commercialization 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 its drug candidates on its anticipated timelines, 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 approved products and other 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, 2023, 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. 

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