Sagimet Biosciences Announces Dosing of First Participants in Phase 1 PK Clinical Trial for Denifanstat and Resmetirom Combination

Core Insights - Sagimet Biosciences Inc. has initiated a Phase 1 pharmacokinetic trial for a combination therapy involving denifanstat and resmetirom, targeting metabolic dysfunction-associated steatohepatitis (MASH) [1][3] - Topline data from this trial is expected in the first half of 2026, which may lead to further development into Phase 2 if results are positive [1][5] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing fatty acid synthase (FASN) inhibitors to address metabolic and fibrotic diseases, particularly MASH [4] - Denifanstat, the lead candidate, is an oral, once-daily selective FASN inhibitor that has shown promise in previous clinical trials, including a successful Phase 2b trial [4] Clinical Trial Details - The Phase 1 trial is an open-label, 2-cohort study enrolling approximately 40 healthy adults, aimed at evaluating pharmacokinetics, drug-drug interactions, safety, and tolerability [2][5] - The trial's results will inform optimal dosing for a subsequent Phase 2 proof-of-concept efficacy trial in F4 MASH patients [2] Scientific Insights - The combination of denifanstat and resmetirom is expected to have synergistic effects, potentially improving clinical outcomes for patients with liver cirrhosis [3] - Preclinical data presented at EASL 2024 indicated that the combination therapy improved liver disease markers more effectively than single agents [3] Market Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver and associated complications [7] - There are currently no approved treatments for MASH cirrhosis (F4), highlighting a significant unmet medical need in this patient population [7]