Sagimet Biosciences and TAPI Announce Global License Agreement for Innovative Forms of Resmetirom API for Sagimet’s Fixed Dose Combination Program

Core Viewpoint - Sagimet Biosciences has entered into a license agreement with TAPI Technology & API Services to develop a fixed-dose combination product targeting metabolic dysfunction-associated steatohepatitis (MASH) [1][2][4] Group 1: License Agreement Details - The agreement grants Sagimet a global, exclusive license to innovative forms of TAPI's resmetirom active pharmaceutical ingredient (API) for technical evaluation and manufacture [2][7] - Sagimet plans to develop a fixed-dose combination product containing denifanstat and resmetirom, with pending patent applications covering both the FDC and innovative resmetirom forms [2][7] Group 2: Clinical Trials and Development Plans - Sagimet has initiated a Phase 1 pharmacokinetic (PK) trial for the combination of denifanstat and resmetirom, with topline data expected by the end of 2025 [3][7] - If the Phase 1 trial results are positive, Sagimet aims to advance the combination into Phase 2 trials for F4 patients with MASH, estimated to start in the second half of 2026 [3][4] Group 3: Company Statements and Insights - The CEO of Sagimet emphasized the importance of the Phase 1 trial and the potential for a synergistic combination of therapies to improve clinical outcomes for patients with liver cirrhosis [4] - TAPI's CEO expressed excitement about the collaboration, highlighting TAPI's expertise in API development and the high medical need for therapies targeting liver cirrhosis [5] Group 4: Background on MASH - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver and associated with inflammation and fibrosis [10] - There are currently no approved treatments for MASH cirrhosis (F4), indicating a significant unmet medical need in this area [10]