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- Data introduced on the Heart Failure Society of America annual scientific assembly
- New evaluation provides to rising physique of proof in help of the use of sotagliflozin, an investigational twin SGLT1 and SGLT2 inhibitor, within the remedy of coronary heart failure
THE WOODLANDS, Texas, Oct. 02, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) in the present day introduced {that a} new evaluation of outcomes from the SOLOIST-WHF Phase 3 outcomes trial of sotagliflozin, an investigational twin SGLT1 and SGLT2 inhibitor, was introduced on the Heart Failure Society of America (HSFA) Annual Scientific Meeting 2022.
The new evaluation was introduced by Bertram Pitt, M.D., FACC, professor of medication emeritus on the University of Michigan, School of Medicine, and co-chair for the SOLOIST-WHF trial in addition to a member of the Executive Committee for the Phase 3 SCORED trial of sotagliflozin. The poster, entitled “Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, Reduces First and Subsequent Heart Failure-related Events in Patients Admitted for Worsening Heart Failure”, was introduced on Sunday, October 2nd throughout the basic poster viewing session IV (https://hfsa.org/hfsa-annual-scientific-meeting-2022).
“Patients treated with sotagliflozin in the SOLOIST-WHF trial experienced fewer single as well as multiple heart failure events than those receiving placebo,” mentioned Dr. Pitt. “Thus, we conclude that sotagliflozin altered the trajectory of patients hospitalized for worsening heart failure by reducing early and recurrent heart failure events.”
“We are pleased that data from the SOLOIST-WHF trial continues to yield robust findings that further help characterize and differentiate the potential benefits of sotagliflozin in heart failure,” mentioned Dr. Craig Granowitz, Lexicon’s senior vice chairman and chief medical officer.
About the SCORED and SOLOIST-WHF Studies
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 research evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to straightforward of care in 10,584 sufferers with sort 2 diabetes, continual kidney illness with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface space, and dangers for heart problems. The main endpoint was the entire quantity of occasions comprised of deaths from cardiovascular causes, hospitalizations for coronary heart failure, and pressing visits for coronary heart failure in sufferers handled with sotagliflozin in contrast with placebo. Key secondary endpoints included whole quantity of occasions 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 research evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to straightforward of care in 1,222 sufferers with sort 2 diabetes who had lately been hospitalized for worsening coronary heart failure. The main endpoint was the entire quantity of occasions comprised of deaths from cardiovascular causes, hospitalizations for coronary heart failure, and pressing visits for coronary heart failure in sufferers handled with sotagliflozin in contrast with placebo.
Both SCORED and SOLOIST-WHF achieved their respective main endpoints, with general tolerability just like placebo throughout each trials. Results from each research had been introduced on the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and concurrently revealed 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 can be accessed at www.nejm.org.
About Sotagliflozin
Discovered utilizing Lexicon’s distinctive strategy to gene science, sotagliflozin is an investigational oral twin inhibitor of two proteins accountable for glucose regulation referred to as sodium-glucose co-transporter sorts 1 and a pair of (SGLT1 and SGLT2). SGLT1 is accountable for glucose absorption within the gastrointestinal tract, and SGLT2 is accountable for glucose reabsorption by the kidney. Sotagliflozin has been studied in a number of affected person populations encompassing coronary heart failure, sort 1 and kind 2 diabetes, and continual kidney illness in fourteen Phase 3 medical research involving roughly 20,000 sufferers.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical firm with a mission of pioneering medicines that remodel sufferers’ lives. Through its Genome5000™ program, Lexicon scientists studied the position and performance of practically 5,000 genes and recognized greater than 100 protein targets with vital therapeutic potential in a spread of illnesses. Through the exact concentrating on of these proteins, Lexicon is pioneering the invention and improvement of progressive medicines to soundly and successfully deal with illness. Lexicon superior one of these medicines to market and has a pipeline of promising drug candidates in discovery and medical and preclinical improvement in coronary heart failure, neuropathic ache, diabetes and metabolism and different indications. For extra data, please go to www.lexpharma.com.
Safe Harbor Statement
This press launch incorporates “forward-looking statements,” together with statements referring to the analysis and medical improvement of, regulatory filings for, and potential therapeutic and industrial potential of sotagliflozin. In addition, this press launch additionally incorporates ahead wanting statements referring to Lexicon’s monetary place and long-term outlook on its business, development and future working outcomes, discovery and improvement of merchandise, strategic alliances and mental property, in addition to different issues that aren’t historic info or data. All forward-looking statements are based mostly on administration’s present assumptions and expectations and contain dangers, uncertainties and different necessary elements, particularly together with Lexicon’s capability to satisfy its capital necessities, efficiently conduct preclinical and medical improvement and procure vital regulatory approvals of sotagliflozin, LX9211 and its different potential drug candidates on its anticipated timelines, efficiently commercialize any merchandise for which it obtains regulatory approval, obtain its operational goals, get hold of patent safety for its discoveries and set up strategic alliances, in addition to extra elements referring to manufacturing, mental property rights, and the therapeutic or industrial worth of its drug candidates. Any of these dangers, uncertainties and different elements might trigger Lexicon’s precise outcomes to be materially totally different from any future outcomes expressed or implied by such forward-looking statements. Information figuring out such necessary elements is contained beneath “Risk Factors” in Lexicon’s annual report on Form 10-Ok for the 12 months ended December 31, 2021, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to replace or revise any such forward-looking statements, whether or not consequently of new data, future occasions or in any other case.
For Inquiries:
Mike Kelly
Lexicon Pharmaceuticals, Inc.
[email protected]
