New Analysis of Phase 3 Data Demonstrating Renal Protective Benefits of Sotagliflozin to be Presented at ASN Kidney Week 2024

THE WOODLANDS, Texas, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a new analysis of its Phase 3 SCORED clinical trial demonstrating the protective effects of sotagliflozin in patients with diabetic kidney disease (DKD). Data will be presented at Kidney Week 2024, the annual meeting of the American Society of Nephrology in San Diego, California.

Previous analyses of the SCORED trial have shown that sotagliflozin, a dual SGLT1 & 2 inhibitor, reduced the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). The objective of this new post hoc analysis of SCORED was to evaluate the effect of sotagliflozin versus placebo on Estimated Glomerular Filtration Rate (eGFR) slope, and the impact of baseline kidney function and glycemia. The eGFR slope assessment is widely used as a surrogate endpoint in cardiovascular and chronic kidney disease trials.

Details for the presentation are as follows:

• “Effect of sotagliflozin on eGFR slope by baseline kidney function and glycemic control” – a moderated poster presentation, Friday, October 25, 10:00a.m.PT, 4:00-5:00p.m, Exhibit Hall, San Diego Convention Center, presented by Vikas S. Sridhar, M.D., University of Toronto, Ontario
  

Within the entire cohort of 10,574 participants, a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (95% CI -2.88, -2.30; p<0.0001) was observed. The total placebo-adjusted slope was -0.08 ml/min/1.73m2/year (95% CI -0.43, 0.27; p=0.67). Compared to placebo, sotagliflozin had a greater benefit on chronic slope with increasing baseline albuminuria (P-interaction=0.023). Full study results will be discussed during the moderated poster and can be accessed here on the Kidney Week website.

“Researchers observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control. This study makes an important contribution to understanding the clinical benefits of sotagliflozin for people with diabetic kidney disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.

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 commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in 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 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, 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.

For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com