Results to be Presented at the European Society for Cardiology Congress Demonstrate Differential Effects During Endothelial Dysfunction in Cell Studies   

Recent Publication in the Journal Diabetes Care Evaluates Metabolic, Intestinal and Cardiovascular Effects in a Clinical Study

The Woodlands, Texas, August 22, 2022 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a series of publications concluding that sotagliflozin’s differentiated dual SGLT1 and SGLT2 mechanism of action may have implications for cardiovascular disease.

  • Two posters will be presented on August 28th and August 29th at the 70th annual European Society of Cardiology Congress, highlighting protein expression analyses comparing sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, with a selective SGLT2 inhibitor in cell-based models relative to inflammation and thrombosis. 
    • The first poster, “Sotagliflozin, a Dual SGLT1/2 Inhibitor, Reduced Expression of Neutrophil Degranulation Proteins During Endothelial Dysfunction Compared with a Selective SGLT2 Inhibitor,” concludes that the favorable effects of sotagliflozin on mechanisms of inflammation have implications for ischemic disease, including myocardial infarction and stroke. 
    • The second poster, “Sotagliflozin, a Dual SGLT1/2 Inhibitor, Reduced Expression of Platelet Activators During Endothelial Dysfunction Compared to Empagliflozin,” concludes that the effects of dual SGLT1 and SGLT2 inhibition on platelet activity may have implications for reduced atherothrombotic risk.
  • A manuscript entitled “Metabolic, Intestinal, and Cardiovascular Effects of Sotagliflozin Compared with Empagliflozin in Patients with Type 2 Diabetes: A Randomized, Double-Blind Study” was recently published online ahead of print in the journal Diabetes Care.  Results from the study showed that, while both agents demonstrated similar effects on many cardiometabolic measures, there were differences in others, such as incremental incretin levels following meals, noted as having potential implications for cardiovascular disease.

“We believe these studies add to the growing body of evidence of the potential benefits of dual SGLT1 and SGLT2 inhibition, and the differentiating effects of the SGLT1 component of sotagliflozin’s mechanism of action on measures with potential implications for cardiovascular disease” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer.  “The results of these studies offer mechanistic evidence supporting the cardioprotective results observed in the SCORED and SOLOIST-WHF Phase 3 cardiovascular outcomes studies which form the basis of Lexicon’s new drug application for FDA approval of sotaglifozin for the treatment of heart failure, including in patients with acute or worsening heart failure.”

About the SCORED and SOLOIST-WHF Studies

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.  Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.

SOLOIST-WHF 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.

Both SCORED and SOLOIST-WHF achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials.  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 Chronic Kidney Disease” and “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” which may be accessed at www.nejm.org.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, type 1 and type 2 diabetes, and chronic kidney disease in fourteen Phase 3 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 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 heart failure, 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 the research and clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, 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 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 sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, successfully commercialize any products for which it obtains regulatory approval, 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 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, 2021, 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:

Mike Kelly
Lexicon Pharmaceuticals, Inc.
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