Sotagliflozin Provides Consistent Relative Risk Reduction in Heart Failure and Major Cardiovascular Events Across All Age Ranges, Including Greater Than 75, in Data Presented at the European Society of Cardiology (ESC) 2025 Congress

THE WOODLANDS, Texas, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced that a post-hoc analysis ("Efficacy of Sotagliflozin Among Older Adults: A Pooled Analysis of SCORED and SOLOIST-WHF") of clinical data was presented Sunday, August 31, during an oral presentation at the European Society of Cardiology (ESC) 2025 Congress in Madrid, Spain.

It is well-established that the incidence of stroke and myocardial infarction (MI, or heart attack), known collectively as major cardiovascular adverse events (MACE), rises with age, as does incidence of heart failure (HF) events. Sotagliflozin, a dual sodium-glucose cotransport 1 and 2 (SGLT-1 and SGLT-2) inhibitor, was approved by the FDA based on its demonstrated efficacy in improving HF endpoints in patients with chronic kidney disease (CKD) or HF. This latest Lexicon-funded analysis examined how the efficacy of sotagliflozin varies with age, particularly among older adults, and used data pooled from the two previous pivotal Phase 3 studies of sotagliflozin, SCORED and SOLOIST-WHF. The robust data set included nearly 12,000 participants, about 70% of whom were 65 or older. This age group represents a very large population in which type 2 diabetes, CKD and/or worsening HF are relatively common. Patients were evaluated by age, both categorically (≥65 years vs <65 years) and continuously. The primary endpoint was total cardiovascular (CV) death, hospitalization for HF, or urgent visit for HF. Additional endpoints included total MACE. Sotagliflozin demonstrated a consistent reduction in both endpoints, as compared to placebo across the spectrum of age.

"Among patients with type 2 diabetes and either chronic kidney disease or heart failure, the addition of sotagliflozin reduced heart failure endpoints and major adverse cardiovascular events, irrespective of age," said Rahul Aggarwal, MD, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, lead study author and presenter of the oral presentation at ESC 2025. "Our team noted meaningful benefit in older adults, including those over the age of 65 and 75 years, who are often at the highest risk for cardiovascular events."

"The findings are unique to sotagliflozin among SGLT inhibitors and demonstrate that people of all ages, including elderly patients, can benefit when sotagliflozin is included in their treatment regimen," said Dr. Craig Granowitz, Lexicon's senior vice president and chief medical officer. "Future research could focus on benefits from sotagliflozin treatment in heart failure patients with preserved ejection fraction, or HFpEF, a population that is generally older and includes more women than other conditions."

Study Results

The pooled analysis of SCORED and SOLOIST-WHF included a total of 5,900 (50.0%) and 5,906 (50.0%) patients were in the sotagliflozin and placebo groups, respectively. The median age of such patients was 69 years (interquartile range: 63, 74 years), with 3,588 (30.4%) and 8,218 (69.6%) patients <65 vs ≥65 years old, respectively.

Compared to placebo, sotagliflozin reduced the rate of the primary endpoint (total CV death and hospitalization or urgent visit for HF) overall (8.5 vs 11.8 events/100 person-years [p-y]; hazard ratio [HR]: 0.72), among adults <65 years (7.6 vs 10.2 events/100 p-y; HR: 0.68), and ≥65 years (8.9 vs 12.4 events/100 p-y; HR: 0.73).

Sotagliflozin similarly reduced total MACE compared with placebo (5.7 vs 7.1 events/100 p-y; HR: 0.80), with consistent findings among adults <65 years (5.1 vs 6.2 events/100 p-y; HR: 0.79) and ≥65 years (5.9 events/100 p-y vs 7.4 events/100 p-y; HR: 0.80).

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. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM).

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 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 commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates, including sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon's 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 commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other 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, 2024, 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.

For Investor and Media Inquiries:  

Lisa DeFrancesco   

Lexicon Pharmaceuticals, Inc.  

[email protected]