Phase 3 Data on Sotagliflozin's Renal Benefits to be Presented at ASN Kidney Week 2024

Lexicon Pharmaceuticals, Inc., based in The Woodlands, Texas, has recently unveiled a new analysis of its Phase 3 SCORED clinical trial, emphasizing the protective benefits of sotagliflozin for patients suffering from diabetic kidney disease (DKD). This new data is set to be presented at Kidney Week 2024, the annual conference of the American Society of Nephrology in San Diego, California.

The SCORED trial previously demonstrated that sotagliflozin, which inhibits both SGLT1 and SGLT2 proteins, could significantly reduce the risk of kidney and cardiorenal complications in patients with type 2 diabetes (T2D) and DKD. The latest post hoc analysis focuses on examining the effects of sotagliflozin compared to a placebo on the Estimated Glomerular Filtration Rate (eGFR) slope. This analysis also considers the influence of initial kidney function and glycemic control on these outcomes. The eGFR slope is a commonly utilized surrogate endpoint in trials related to cardiovascular and chronic kidney diseases.

The findings of this analysis will be shared in a moderated poster presentation titled “Effect of sotagliflozin on eGFR slope by baseline kidney function and glycemic control.” This session is scheduled for Friday, October 25, from 10:00 a.m. to 5:00 p.m. Pacific Time, in Exhibit Hall at the San Diego Convention Center. Dr. Vikas S. Sridhar from the University of Toronto, Ontario, will present the results.

In the cohort comprising 10,574 participants, a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (with a 95% confidence interval of -2.88 to -2.30; p<0.0001) was observed. The overall placebo-adjusted slope was -0.08 ml/min/1.73m2/year (with a 95% confidence interval of -0.43 to 0.27; p=0.67). Sotagliflozin showed a superior benefit on chronic slope with increasing baseline albuminuria (P-interaction=0.023) compared to the placebo. Detailed results of the study will be discussed during the poster presentation and can be accessed on the Kidney Week website.

Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, stated, "The study observed positive renal protection with sotagliflozin across various ranges of baseline kidney function and glycemic control. This study significantly enhances our understanding of the clinical benefits of sotagliflozin for individuals with diabetic kidney disease."

Sotagliflozin is an oral drug discovered through Lexicon’s innovative gene science approach. It inhibits two proteins, sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2), that are key to glucose regulation. SGLT2 is responsible for glucose and sodium reabsorption in the kidneys, whereas SGLT1 manages glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been examined in various patient groups, including those with heart failure, diabetes, and chronic kidney disease, through clinical studies involving approximately 20,000 patients.

Lexicon Pharmaceuticals is a biopharmaceutical company dedicated to developing groundbreaking medicines that significantly improve patients' lives. Utilizing the Genome5000™ program, Lexicon’s proprietary genomics target discovery platform, their scientists have studied nearly 5,000 genes and identified over 100 protein targets with considerable therapeutic potential for various diseases. Lexicon has successfully brought one of these medicines, INPEFA® (sotagliflozin), to market in the United States and continues to develop other promising drug candidates for conditions such as neuropathic pain, diabetes, and other metabolic disorders.