Sotagliflozin reduced the risk of cardiovascular death and heart failure readmissions in patients hospitalized for worsening heart failure events in SOLOIST-WHF study
Sotagliflozin NDA for treatment of heart failure on track for May 27, 2023 PDUFA action date
THE WOODLANDS, Texas, May 10, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that results of a new investigator-initiated economic analysis, based on results from the SOLOIST-WHF Phase 3 outcomes study of its investigational medicine sotagliflozin, were presented on May 9 at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting in Boston, Massachusetts.
The analysis was led by the MedStar Health Research Institute in Washington, D.C. and was conducted from a U.S. healthcare sector perspective, in accordance with Consolidated Health Economic Evaluation Reporting Standards. The analysis was based on nine-month median follow-up data from the 1,222 patients enrolled in the Phase 3 SOLOIST-WHF trial and designed to extrapolate costs, life expectancy, and quality-adjusted life expectancy to estimate sotagliflozin’s cost-effectiveness. The researchers determined that sotagliflozin is a clinically and economically attractive medication and is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening heart failure.
Heart failure is the leading cause of hospitalization for Americans over the age of 65. Patients with heart failure are at highest risk of having a repeat heart failure event in the first 30 days post-discharge, with 7% dying and 25% being rehospitalized within one month.
“With the prevalence of heart failure rising at an ever-increasing rate and hospitalizations driving a significant majority of healthcare costs relating to heart failure, it is clear that we need to do more,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We are closer than ever to potentially providing an additional treatment option for heart failure patients transitioning out of the hospital and helping to reduce the financial and physical burdens of rehospitalizations.”
Results from SOLOIST-WHF showed that sotagliflozin significantly reduced hospitalizations for heart failure, urgent visits for heart failure, and the risk of cardiovascular deaths by 33% compared to placebo. Further post-hoc analyses concluded that initiating treatment with sotagliflozin prior to hospital discharge reduced the composite of urgent care for heart failure or cardiovascular death within 27 days and that sotagliflozin reduced the risk of cardiovascular death and heart failure hospitalizations by approximately 50% at 30 and 90 days after discharge, compared to placebo. These findings were generally consistent across the range of left ventricular ejection fraction, or LVEF.
Lexicon’s NDA for sotagliflozin for the treatment of heart failure is on track for its May 27, 2023 PDUFA action date.
About Heart Failure
About 6.7 million Americans suffer from heart failure, a progressive, debilitating condition that is becoming more prevalent. It is the leading cause of hospitalizations for people aged 65 and older, triggering approximately 1.3 million hospitalizations a year. Annual costs from heart failure are expected to increase to nearly $70 billion by 2030, with 80% of those costs due to hospitalizations.
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, 2022, 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 Cocuzza
Lexicon Pharmaceuticals, Inc.
acocuzza@lexpharma.com
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