Lexicon to Present Phase 3 Trial Design for Sotagliflozin in Hypertrophic Cardiomyopathy (HCM) at Upcoming Medical Congress

Patient randomization is underway in SONATA-HCM clinical trial evaluating Lexicon's novel dual SGLT1 and SGLT2 inhibitor in this underserved and growing patient population

 Study design intended to enable supplemental new drug application (sNDA) with a broad label in both obstructive and non-obstructive HCM

THE WOODLANDS, Texas, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it will unveil study design details of SONATA-HCM, the company's Phase 3 clinical trial of sotagliflozin as a potential new treatment for adults with hypertrophic cardiomyopathy (HCM), at the virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions. Lexicon plans to conduct the multinational study at 130 sites in 20 countries and enroll adults aged 18 years or older diagnosed with symptomatic HCM, either obstructive (oHCM) or non-obstructive (nHCM). Initial study sites have been activated and patient randomization is underway.

Details for the presentation on "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)" is as follows:

• HCMS (virtual) – a moderated poster presentation, Friday, September 27, 2:00-2:30p.m. ET, presented by Carolyn Y. Ho, M.D., Cardiology, Brigham and Women's Hospital, Boston, MA
  
  

The estimated prevalence of HCM in the United States is about 1.1 million. The most common patient-reported symptoms include shortness of breath, lightheadedness or dizziness, fatigue, heart fluttering or palpitations, and limitations to physical activities.

"SONATA-HCM will evaluate the efficacy of sotagliflozin, a dual SGLT2 and SGLT1 inhibitor, on symptoms, function, and other patient-reported outcomes, as well as safety in patients with symptomatic HCM," said Dr. Ho, M.D., Cardiology, Brigham and Women's Hospital, and a co-author of the study abstract.

"Despite recent advances in the treatment of HCM, there remain significant needs among patients and clinicians for new therapeutic options," said Sharlene M. Day, M.D., Director, Translational Research, Division of Cardiovascular Medicine and Cardiovascular Institute, Presidential Associate Professor, University of Pennsylvania Medicine, and a co-author of the study abstract. "Although HCM is a unique condition, there are overlapping features with other conditions that lead to heart failure, so I'm optimistic that sotagliflozin could work in this patient population."

"We are excited about the potential for sotagliflozin to become a safe and effective treatment for HCM, either as standalone therapy or in conjunction with currently available medications," said Craig Granowitz, M.D., Ph.D., Lexicon's senior vice president and chief medical officer. "Based on our interactions with FDA, and if supported by positive study results, we plan to submit a supplemental new drug application (sNDA) with a broad proposed label to improve symptoms and physical limitations in adults with HCM."

For more information on the study, visit the SONATA-HCM page on ClinicalTrials.gov.

About Sotagliflozin

Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in 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 the Genome5000™ program, Lexicon's unique genomics target discovery platform, 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 treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in 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 commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery, development and commercialization 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 commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, 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 approved products and other 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, 2023, 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 and Media Inquiries:

Lisa DeFrancesco

Lexicon Pharmaceuticals, Inc.

[email protected]