Sagimet Biosciences Announces Positive Results from the Phase 1 PK Clinical Trial of Denifanstat and Resmetirom Combination

Core Insights - Sagimet Biosciences Inc. announced positive results from the Phase 1 pharmacokinetic trial of its combination therapy involving denifanstat and resmetirom, targeting metabolic dysfunction-associated steatohepatitis (MASH) [1][4] Group 1: Trial Details - The Phase 1 PK trial was an open-label, 2-cohort study with 40 healthy adult participants, aimed at evaluating pharmacokinetics, potential drug-drug interactions, and safety [2] - The combination of denifanstat and resmetirom was well-tolerated, with no serious adverse events or clinically significant laboratory results reported [3][7] Group 2: Future Development Plans - Sagimet plans to advance the combination therapy into a Phase 2 proof-of-concept efficacy trial for patients with MASH and F4 fibrosis, pending regulatory consultation [4][5] - The company aims to initiate the Phase 2 study in the second half of 2026, leveraging data from the Phase 1 trial [5][7] Group 3: Product Information - Denifanstat is an oral, once-daily selective FASN inhibitor, while resmetirom is commercially available as Rezdiffra for non-cirrhotic MASH with moderate to advanced fibrosis [5][6] - Preclinical data indicated a synergistic effect of the combination on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [5][6] Group 4: Market Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver and associated metabolic changes [8] - There are currently no approved treatments for MASH cirrhosis (F4), highlighting a significant unmet medical need [8]