GlobeNewswire Inc | Nov 9, 2021 08:00AM EST

November 09, 2021

THE WOODLANDS, Texas, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis of sotagliflozin results from the SOLOIST and SCORED Phase 3 outcomes studies will be presented at the virtual American Heart Association Scientific Sessions 2021.

The new analysis will be presented by 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 SOLOIST and SCORED trials. The presentation is entitled, Cardiovascular Benefits of Sodium Glucose Cotransporter-1/2 Inhibition with Sotagliflozin Across Baseline Kidney Function.

The presentation will be broadcast live at 8:24 a.m. Eastern on Sunday, November 14 during the main featured science session entitled, Cardiometabolic Disease and Heart Failure: Digging Deeper and Treating Earlier and the abstract will be posted on the AHA website at that time.

About the SOLOIST and SCORED Studies

SOLOIST 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 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. 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.

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.

Both SOLOIST and SCORED achieved their respective primary endpoints. Results from both studies were presented 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 two separate articles titled: Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure and Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.

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 neuropathic pain, heart failure, 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 Lexicons 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 Lexicons 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 managements current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicons 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, 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 Lexicons 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 Lexicons annual report on Form 10-K for the year ended December 31, 2020, 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 Inquiries

Chas SchultzExecutive Director, Corporate Communications and Investor RelationsLexicon Pharmaceuticals(281) 863-3421cschultz@lexpharma.com