New Analysis of SOLOIST-WHF Results Demonstrates

THE WOODLANDS, Texas, Nov. 06, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), right this moment introduced {that a} new evaluation of outcomes from the SOLOIST-WHF Phase 3 outcomes examine of its investigational coronary heart failure therapy sotagliflozin, was offered on 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 through the ‘Advances in Diabetes and Heart Failure: From Bench to Bedside’ session.

Treatment with sotagliflozin demonstrated vital relative threat reductions of 46% to 52% for readmission for non-fatal coronary heart failure occasions and for the composite of cardiovascular loss of life and readmission for coronary heart failure at 30 or 90 days following hospital discharge versus placebo.

Heart failure is the primary trigger of hospitalizations for Americans ages sixty-five years and older, with roughly a million hospitalizations for coronary heart failure yearly within the United States. On common, twenty-five % of sufferers will undergo one other coronary heart failure occasion and should be readmitted to the hospital inside 30 days of their preliminary discharge, and that quantity jumps to 65% of sufferers who will probably be readmitted inside one 12 months. Heart failure value burden is projected to succeed in almost seventy billion {dollars} within the United States by the 12 months 2030, with 80% of these whole prices associated to hospitalizations.

“These results with sotagliflozin are meaningful for the patient, the caregiver, and the healthcare system overall,” mentioned Bertram Pitt, M.D., FACC, professor of drugs emeritus on the University of Michigan, School of Medicine, and presenter of the outcomes from the brand new evaluation. “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,” mentioned Dr. Craig Granowitz, Lexicon’s senior vp 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 examine 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 major endpoint was the whole 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.

SOLOIST-WHF achieved its major endpoint, with total tolerability much like placebo. Results had been offered 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 an article titled: “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 answerable for glucose regulation often known as sodium-glucose co-transporter sorts 1 and a couple of (SGLT1 and SGLT2). SGLT1 is answerable for glucose absorption within the gastrointestinal tract, and SGLT2 is answerable 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 persistent kidney illness in fourteen Phase 3 scientific research involving roughly 20,000 sufferers.

About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical firm with a mission of pioneering medicines that rework sufferers’ lives. Through its Genome5000™ program, Lexicon scientists studied the position and performance of almost 5,000 genes and recognized greater than 100 protein targets with vital therapeutic potential in a spread of illnesses. Through the exact focusing on of these proteins, Lexicon is pioneering the invention and improvement of modern medicines to securely and successfully deal with illness. Lexicon superior one of these medicines to market and has a pipeline of promising drug candidates in discovery and scientific and preclinical improvement in coronary heart failure, neuropathic ache, diabetes and metabolism and different indications. For further info, please go to www.lexpharma.com.

Safe Harbor Statement

This press launch incorporates “forward-looking statements,” together with statements regarding the analysis and scientific improvement of, regulatory filings for, and potential therapeutic and business potential of sotagliflozin. In addition, this press launch additionally incorporates ahead wanting statements regarding 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 info. All forward-looking statements are primarily based on administration’s present assumptions and expectations and contain dangers, uncertainties and different essential elements, particularly together with Lexicon’s skill to fulfill its capital necessities, efficiently conduct preclinical and scientific improvement and procure needed 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, acquire patent safety for its discoveries and set up strategic alliances, in addition to further elements regarding manufacturing, mental property rights, and the therapeutic or business 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 essential 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 because of this of new info, future occasions or in any other case.

For Investor Inquiries:

Mike Kelly
Lexicon Pharmaceuticals, Inc.
[email protected]

For Media Inquiries:

Alina Kolomeyer
Lexicon Pharmaceuticals, Inc.
[email protected]