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New Analyses of Sotagliflozin to Be Presented at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology

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Lexicon Pharmaceuticals (Nasdaq: LXRX) announced the upcoming presentation of new analyses from the SOLOIST-WHF Phase 3 study of sotagliflozin at the American College of Cardiology’s 72nd Annual Scientific Session on March 4-6, 2023, in New Orleans. The presentations will include topics such as the time to clinical benefit and effects on symptoms and quality of life in patients with worsening heart failure. The SOLOIST-WHF study, involving 1,222 patients with type 2 diabetes, evaluated the cardiovascular efficacy of sotagliflozin compared to placebo and achieved its primary endpoint, demonstrating overall tolerability similar to placebo, as previously published in The New England Journal of Medicine.

Positive
  • SOLOIST-WHF trial achieved primary endpoint of reducing cardiovascular events.
  • Sotagliflozin is backed by extensive research, having been studied in 14 Phase 3 trials with around 20,000 patients.
Negative
  • None.

Featured presentation on the time to clinical benefit of sotagliflozin in people with worsening heart failure

THE WOODLANDS, Texas, Feb. 20, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced the upcoming presentation of new analyses of results from the SOLOIST-WHF Phase 3 outcomes study of its investigational sotagliflozin product at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana.

The following analyses of sotagliflozin have been selected for presentation:

About the SOLOIST-WHF Study

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.

SOLOIST-WHF achieved its primary endpoint, with overall tolerability similar to placebo. Results 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 an article titled: “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 Investor Inquiries:

Carrie Siragusa
Lexicon Pharmaceuticals, Inc.
csiragusa@lexpharma.com

For Media Inquiries:

Alina Kolomeyer
Lexicon Pharmaceuticals, Inc.
akolomeyer@lexpharma.com


FAQ

What are the key findings of the SOLOIST-WHF study for sotagliflozin?

The SOLOIST-WHF study demonstrated that sotagliflozin achieved its primary endpoint in reducing cardiovascular events in patients with type 2 diabetes and worsening heart failure.

When and where will the results of the SOLOIST-WHF study be presented?

Results will be presented at the American College of Cardiology’s 72nd Annual Scientific Session in New Orleans from March 4-6, 2023.

What is the significance of sotagliflozin in treating heart failure?

Sotagliflozin is a dual SGLT 1 and 2 inhibitor that has shown promise in improving heart failure outcomes, including quality of life for patients.

What is the primary endpoint of the SOLOIST-WHF study?

The primary endpoint includes the total number of cardiovascular-related deaths, heart failure hospitalizations, and urgent visits for heart failure.

How many patients were involved in the SOLOIST-WHF trial?

The SOLOIST-WHF trial involved 1,222 patients with type 2 diabetes who experienced worsening heart failure.

Lexicon Pharmaceuticals, Inc.

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