Statistically significant reduction in the risk for the primary outcome on Day 27
Findings generally consistent across the left ventricular ejection fraction (LVEF) range
THE WOODLANDS, Texas, March 04, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced new analyses of results from the SOLOIST-WHF Phase 3 outcomes study of its investigational product sotagliflozin presented 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 “Time to Clinical Benefit of Sotagliflozin in People with Worsening Heart Failure in SOLOIST-WHF” post hoc analysis examined the timing of clinical benefit of sotagliflozin, defined as the first day post randomization when the hazard ratio (HR) for risk for the primary outcome of total number of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure was statistically significant (p<0.05) and remained significant throughout follow up. A subgroup analysis was also conducted in patients with left ventricular ejection fraction (LVEF) < 50% or ≥ 50%.
The analysis showed a statistically significant reduction in the risk for the primary outcome on Day 27, or time to clinical benefit of 27 days, in patients with worsening heart failure (WHF) treated with sotagliflozin. Furthermore, these findings were generally consistent across the LVEF range.
“Patients with heart failure admitted with worsening disease are at substantial risk for rehospitalization and death in the short-term,” stated Dr. Deepak L. Bhatt, Director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai. “In SOLOIST-WHF, early initiation of sotagliflozin reduced the risk of cardiovascular events in the short-term and also in the long-term.”
As previously reported, in patients admitted with WHF, sotagliflozin significantly reduced the composite of total cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (UVHF) by 33%.
“With the prevalence of heart failure rising at an ever-increasing rate and hospitalizations driving a significant majority of healthcare and societal costs, it is clear that we need to do more,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer. “We are closer than ever to potentially improving care for heart failure patients transitioning out of the hospital in an effort to avoid the burden of rehospitalizations.”
For more information on ACC.23 Together With WCC (ACC.23/WCC) please click here.
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.
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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