Sagimet Biosciences(US:SGMT) Globenewswire·2025-10-07 11:00Core Insights - Sagimet Biosciences Inc. announced positive results from the Phase 2b FASCINATE-2 study, showing that denifanstat improved fibrosis in patients with advanced fibrosis, to be presented at AASLD 2025 [1][2] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing fatty acid synthase (FASN) inhibitors targeting metabolic and fibrotic pathways [3] - The lead drug candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction associated steatohepatitis (MASH) [3] - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3] Clinical Study Details - The FASCINATE-2 study demonstrated a significant ≥2-stage improvement in fibrosis in F3 MASH patients [2] - The analysis utilized AI-based digital pathology to identify a subgroup of MASH patients with advanced baseline fibrosis (qF4), showing denifanstat's effectiveness in reducing fibrosis and improving non-invasive test biomarkers [2] Disease Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver, inflammation, and fibrosis [4] - Patients with advanced fibrosis (F3) or cirrhosis (F4) face the highest risk of severe liver-related outcomes [4] - There are limited approved treatments for non-cirrhotic MASH and none for MASH cirrhosis [4]