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Sagimet Biosciences Announces Successful Completion of End-of-Phase 2 Interactions with FDA on the Development of Denifanstat for MASH; Phase 3 Program Initiation Expected by End of 2024
The planned registration program consists of two double-blind, placebo-controlled multicenter Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate the safety
About this update from Sagimet Biosciences Inc. - Series A
[{"type":"text","content":"The planned registration program consists of two double-blind, placebo-controlled multicenter Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate the safety and efficacy of denifanstat in patients with MASH and MASLD SAN MATEO, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced the successful completion of end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), supporting the advancement of denifanstat into Phase 3 in metabolic-dysfunction associated steatohepatitis (MASH). The planned program will include two Phase 3 trials: FASCINATE-3, evaluating patients with F2/F3 (non-cirrhotic) MASH, and FASCINIT, evaluating patients with suspected or confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH. The Phase 3 program is expected to initiate by the end of 2024. “Following the recent Breakthrough Therapy designation for denifanstat for treatment of non-cirrhotic MASH, we are pleased with the outcome of our end-of-Phase 2 interactions with the FDA and are appreciative of the agency’s support and guidance on our Phase 3 program for denifanstat in MASH,” said Dave Happel, Chief Executive Officer of Sagimet. “The agency supports our strategy to conduct two Phase 3 trials to assess the safety and efficacy of denifanstat in F2/F3 MASH, a complex disease where treatments with novel/differentiated mechanisms of action that directly target the three main drivers of liver injury: fat accumulation, inflammation, and fibrosis are urgently needed.” 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 (non-cirrhotic) 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 ...