Guidelines issued jointly by the American Heart Association, American College of Cardiology
and Heart Failure Society of America
New guidelines recommend the use of SGLT inhibitors for the prevention and treatment of heart failure and highlight the need to improve optimization of medical therapies during hospitalizations
The Woodlands, Texas, April 4, 2022 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) welcomes new guidelines for the management of heart failure issued jointly this past weekend by the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Failure Society of America (HFSA).
The guidelines now recommend the use of SGLT2 inhibitors in the prevention and treatment of heart failure with the highest-level recommendations among classes of therapy in each category. The guidelines recommend SGLT2 inhibitors for the treatment of heart failure with reduced ejection fraction (HFrEF) with a recommendation equivalent to preexisting standard-of-care classes of therapy and for the treatment of heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) with a recommendation stronger than for any other class of therapy. In support, the guidelines specifically cite clinical trials of two selective SGLT2 inhibitors recently approved for heart failure and the SOLOIST-WHF study of dual SGLT1 and SGLT2 inhibitor sotagliflozin in patients admitted for worsening heart failure. The guidelines also highlight the need to improve optimization of medical therapies during heart failure hospitalizations.
“We expect that the new joint guidelines issued this weekend by the three largest cardiology societies in the United States, along with the new guidelines issued last year by the European Society of Cardiology, will support the emerging adoption of SGLT2 inhibitors as a first line treatment standard across heart failure,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer at Lexicon. “We believe that sotagliflozin’s unique mechanism offers opportunities for differentiation within the class, supported by the results from the SOLOIST-WHF study referenced in the guidelines as well as from the SCORED study, additional analyses from which were presented at the American College of Cardiology 71st Annual Scientific Sessions this weekend.”
The “2022 AHA/ACC/HFSA Guideline of the Management of Heart Failure” replaces the “2013 ACCF/AHA Guideline for the Management of Heart Failure” and its accompanying “2017 ACC/AHA/HFSA Focused Update.” The full guidelines were published in the Journal of the American College of Cardiology (JACC) and can be found at jacc.org.
About the SOLOIST-WHF and SCORED Studies
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.
SCORED 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 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. 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. Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.
Both SOLOIST-WHF and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies 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 two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease” 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 Lexicon’s financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin, LX9211 and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s 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.
Executive Director, Corporate Communications and Investor Relations