FDA gives regulatory feedback for phase III SOLOIST and SCORED trials of Zynquista in CV risk with type 2 diabetes.- Lexicon Pharma

Lexicon Pharmaceuticals announced that it has received FDA regulatory feedback that the results of its SOLOIST and SCORED Phase III clinical studies of Zynquista (sotagliflozin) can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure. The feedback was provided in response to a request made by Lexicon following the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based on the results of such studies, taking into account their early close-out and other considerations. This regulatory feedback clears a key hurdle for partnership discussions around sotagliflozin in heart failure and enables a potential NDA filing in 2021. SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase III 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 III 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. Both SOLOIST and SCORED achieved their respective primary endpoints. 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.”