Full Press Release Details
-- In a randomized crossover study, sotagliflozin significantly reduced ex vivo thrombus formation from baseline under both arterial and venous flow conditions --
-- Study in living human heart tissue indicate sotagliflozin acutely and directly reduces myocardial work in hypertrophic cardiomyopathy (HCM) --
-- Findings add mechanistic insight into sotagliflozin's dual SGLT1/SGLT2 inhibition ahead of SONATA-HCM topline results in Q1 2027 --
THE WOODLANDS, Texas, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a leading cardiometabolic biopharmaceutical company, today announced new data highlighting the cardiovascular effects of its dual SGLT1/2 inhibitor, sotagliflozin, which were shared in two poster presentations at the American Heart Association (AHA) Scientific Sessions 2026. The investigator-initiated studies were sponsored by Lexicon and conducted by investigators at the Ichan School of Medicine at Mount Sinai and Penn Cardiovascular Institute.
In the first presentation, "Zafar et al. Effects of Sotagliflozin and Empagliflozin on Thrombus Formation in Healthy Volunteers: A Randomized Crossover Trial", researchers from the Ichan School of Medicine examined whether sotagliflozin reduces the blood's tendency to form clots, which are the leading cause of heart attacks and strokes.
In the 4-week, randomized, open-label crossover study, 15 healthy adults received once-daily sotagliflozin 400 mg and the selective SGLT2 inhibitor empagliflozin 10 mg in random order. Researchers measured clot formation in participants' blood before and after each treatment, using an ex vivo laboratory model in which blood is drawn over a system that mimics a damaged artery and at speeds that replicate arterial and venous blood flow. Sotagliflozin significantly reduced clot formation from baseline under both arterial-like (11.9%; p=0.043) and venous-like (15.6%; p=0.012) conditions. Reductions with empagliflozin did not reach statistical significance.
The second presentation, "Taichman et al. Load-Dependent Effects of Sodium Glucose Co-Transporter Inhibitors on Work in Human Hypertrophic Cardiomyopathy Living Myocardial Slices," examined whether sotagliflozin acts directly on human heart muscle affected by HCM.
Researchers at Penn Cardiovascular Institute used heart tissue removed from patients with HCM during septal myectomy, a surgery to relieve obstruction, along with tissue from non-failing donor hearts. In an ex vivo model using living myocardial slices, myocardial work was studied across a physiologic range of afterloads, or the pressures the heart pumps against. Short-term exposure to sotagliflozin and empagliflozin directly reduced the work performed by the heart muscle. Sotagliflozin showed increased potency versus empagliflozin at higher afterloads, which mimics the HCM condition. The findings indicate that sotagliflozin can act directly on the heart, independent of its effects on the kidneys and metabolism. The findings were simultaneously published in JACC: Basic to Translational Science.
"A growing body of research continues to suggest that adding SGLT1 inhibition may contribute to cardiovascular effects beyond those seen with SGLT2 inhibition alone," said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon. "The thrombosis data point to a potential mechanism behind the reductions in heart attack and stroke seen in SCORED, while the human tissue findings show a direct effect of sotagliflozin on the hypercontractile heart muscle that characterizes HCM. Together, these new datasets strengthen the scientific rationale for sotagliflozin in HCM and reinforce our excitement for the pivotal readout of our SONATA-HCM study."
The ongoing Phase 3 SONATA-HCM trial is evaluating sotagliflozin as a potential treatment option for patients with symptomatic obstructive and non-obstructive HCM. Topline results are expected in the first quarter of 2027.
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 and the heart. 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 hypertrophic cardiomyopathy (HCM).
About Lexicon Pharmaceuticals Lexicon Pharmaceuticals is a biopharmaceutical company pursuing novel medicines for patients with serious cardiometabolic diseases. Building on a proven legacy in genetic target discovery, Lexicon is advancing a clinical pipeline in areas of significant and often underserved need, with programs in hypertrophic cardiomyopathy (HCM), type 1 diabetes (T1D), obesity and other related metabolic conditions. Lexicon is committed to developing differentiated therapies that can be integrated broadly into clinical practice, with the goal of expanding treatment options for patients. Its capabilities extend from early-stage target discovery through clinical development and commercialization, strategically paired with high-impact collaborations to maximize the global reach of its medicines. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement This press release contains "forward-looking statements," including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin, including in hypertrophic cardiomyopathy. In addition, this press release may also contain forward-looking 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. 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, 2025, 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.