New analysis of Phase III SCORED trial of sotagliflozin in patients with diabetic kidney disease.- Lexicon Pharma

Lexicon Pharmaceuticals, Inc.  announced a new analysis of its Phase III SCORED clinical trial demonstrating the protective effects of sotagliflozin in patients with diabetic kidney disease (DKD). Data will be presented at Kidney Week 2024, the annual meeting of the American Society of Nephrology in San Diego, California. Previous analyses of the SCORED trial have shown that sotagliflozin, a dual SGLT1 & 2 inhibitor, reduced the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). The objective of this new post hoc analysis of SCORED was to evaluate the effect of sotagliflozin versus placebo on Estimated Glomerular Filtration Rate (eGFR) slope, and the impact of baseline kidney function and glycemia. The eGFR slope assessment is widely used as a surrogate endpoint in cardiovascular and chronic kidney disease trials.

Within the entire cohort of 10,574 participants, a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (95% CI -2.88, -2.30; p<0.0001) was observed. The total placebo-adjusted slope was -0.08 ml/min/1.73m2/year (95% CI -0.43, 0.27; p=0.67). Compared to placebo, sotagliflozin had a greater benefit on chronic slope with increasing baseline albuminuria (P-interaction=0.023). Full study results will be discussed during the moderated poster and can be accessed here on the Kidney Week website.

“Researchers observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control. This study makes an important contribution to understanding the clinical benefits of sotagliflozin for people with diabetic kidney disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.