Lexicon Pharmaceuticals Announces Submission of Additional Data to FDA Supporting the Benefit-Risk Profile of Zynquista in Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. recently announced it has submitted additional clinical data to the US FDA from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D).
The submission of additional clinical data follows a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1), the Joslin Diabetes Center (SUGARNSALT) and the University of Dundee (SOPHIST) supporting the benefit-risk profile of Zynquista in T1D.
“There has been an outpouring of patient support advocating for the approval of Zynquista in T1D,” said Dr. Mike Exton, PhD, Chief Executive Officer and director of Lexicon Pharmaceuticals. “While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering.”
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.
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 a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For more information, visit www.lexpharma.com.
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