Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis of results from the SOLOIST-WHF Phase 3 outcomes study of its investigational heart failure treatment sotagliflozin, was presented at the American Heart Association Scientific Sessions 2022 in Chicago, Illinois. The oral presentation, titled “The effect of the dual SGLT1 and 2 inhibitor sotagliflozin on cardiovascular mortality and hospital readmission rates for heart failure at 30- and 90-days post discharge in patients with type 2 diabetes hospitalized for worsening heart failure in the SOLOIST-WHF trial,” was delivered at 3:30pm CT this afternoon during the ‘Advances in Diabetes and Heart Failure: From Bench to Bedside’ session.

Treatment with sotagliflozin demonstrated significant relative risk reductions of 46% to 52% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30 or 90 days following hospital discharge versus placebo.

Heart failure is the number one cause of hospitalizations for Americans ages sixty-five years and older, with approximately one million hospitalizations for heart failure annually in the United States. On average, twenty-five percent of patients will suffer another heart failure event and need to be readmitted to the hospital within 30 days of their initial discharge, and that number jumps to 65% of patients who will be readmitted within one year. Heart failure cost burden is projected to reach nearly seventy billion dollars in the United States by the year 2030, with 80% of those total costs related to hospitalizations.

“These results with sotagliflozin are meaningful for the patient, the caregiver, and the healthcare system overall,” said Bertram Pitt, M.D., FACC, professor of medicine emeritus at the University of Michigan, School of Medicine, and presenter of the results from the new analysis. “Hospital readmissions are burdensome, time-consuming, and costly. This analysis provides evidence that sotagliflozin has the potential to address all of these concerns if administered to patients prior to or at hospital discharge after experiencing an episode of worsening heart failure.”

“The SOLOIST-WHF trial continues to yield robust findings that further help characterize and differentiate the efficacy and safety profile of sotagliflozin in patients with acute or worsening heart failure,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer. “Importantly, based on this new analysis by Dr. Bertram Pitt, sotagliflozin may reduce the likelihood of readmission rates for heart failure events and thus reduce the significant burden on patients, caregivers and the healthcare system.”

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.

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