Sagimet Biosciences Presents Two Denifanstat Posters at AASLD—The Liver Meeting® 2025

Core Insights - Sagimet Biosciences presented two posters at the AASLD 2025, highlighting the efficacy of denifanstat in treating advanced fibrosis in MASH patients [1][2] - Denifanstat demonstrated significant improvements in fibrosis, inflammation, and steatosis, particularly in patients with advanced fibrosis defined as qF4 [1][2][6] Group 1: Clinical Trial Results - A secondary analysis of the Phase 2b FASCINATE-2 trial showed that denifanstat treatment led to a significant ≥2-stage improvement in fibrosis for F3 MASH patients, with a response rate of 34% compared to 4% in placebo [6] - In the qF4 MASH subgroup, denifanstat improved fibrosis by 1-2 stages, achieving an 85% response rate for ≥1 stage regression versus 33% in placebo [2][6] - Noninvasive biomarkers showed significant reductions in qF4 patients treated with denifanstat, including a 29% decrease in FibroScan (kPa) and a 43% decrease in ALT levels [6] Group 2: Methodology and Predictive Analysis - The first poster utilized AI-based digital pathology to identify advanced fibrosis in MASH patients and assess liver histology improvement [2] - The second poster employed spatial computational histology to predict responses to denifanstat based on baseline fibrosis features, indicating the potential for computational pathology in response stratification [3] Group 3: Company Overview and Future Directions - Sagimet is focused on developing novel therapeutics targeting metabolic and fibrotic pathways, with denifanstat being an oral, once-daily medication that met all primary endpoints in its Phase 2b trial [7] - The company is also exploring a combination therapy of denifanstat and resmetirom in a Phase 1 clinical trial, aimed at cirrhotic patients with F4-stage MASH [7] - Sagimet's pipeline includes another oral FASN inhibitor, TVB-3567, currently in a Phase 1 first-in-human clinical trial for acne [7]