Sagimet Biosciences completes End-of-Phase 2 meeting with FDA on denifanstat

Sagimet Biosciences (SGMT) announced the completion of end-of-Phase 2 interactions with the U.S. Food and Drug Administration, supporting the advancement of denifanstat into Phase 3 in metabolic-dysfunction associated steatohepatitis. The planned program will include two Phase 3 trials: FASCINATE-3, evaluating patients with F2/F3 MASH, and FASCINIT, evaluating patients with suspected or confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease/MASH. The Phase 3 program is expected to initiate by the end of 2024. Based on ongoing discussions with the FDA, the planned Phase 3 program will consist of two double-blind, placebo-controlled multicenter registrational trials: FASCINATE-3 in patients with F2/F3 MASH: The trial will evaluate the efficacy and safety of denifanstat in this population, with primary endpoints being liver biopsy and 4.5-year clinical outcomes. FASCINIT in patients with suspected or confirmed diagnosis of MASLD/MASH: The trial will evaluate the efficacy and safety of denifanstat in this population, with primary endpoints being safety and tolerability. Non-invasive biomarkers will be assessed as part of the secondary endpoints, and there will be no end-of-treatment liver biopsy. The Phase 3 program is designed to comprise a minimum of 1,800 patients exposed to denifanstat.