Sagimet Biosciences(US:SGMT) GlobeNewswire News Room·2024-10-11 11:00Core Insights - Sagimet Biosciences announced significant results from the Phase 2b FASCINATE-2 clinical trial of denifanstat, showing improvements in disease activity, MASH resolution, and fibrosis, supporting its advancement to Phase 3 development [1][2][4] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to target metabolic and fibrotic pathways [8] - Denifanstat is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [8] Clinical Trial Results - The FASCINATE-2 trial involved 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis, demonstrating statistically significant improvements in primary endpoints at week 52 [7] - Denifanstat-treated patients showed a 36% MASH resolution rate without worsening fibrosis compared to 13% in the placebo group (p=0.0044) [3] - A 52% reduction in NAS without worsening fibrosis was observed in denifanstat-treated patients versus 20% in placebo (p=0.0003) [3] Secondary Endpoints - Fibrosis improvement by ≥1 stage without worsening of steatohepatitis was seen in 41% of denifanstat-treated patients compared to 18% with placebo (p=0.0103) [5] - In patients with F3 fibrosis, 49% showed improvement with denifanstat versus 13% with placebo (p=0.0032) [5] - Non-invasive biomarkers indicated improvements in liver health, including decreased liver fat and liver enzymes [6] Safety Profile - No treatment-related serious adverse events were reported, with most adverse events being mild to moderate [6] - There were no Grade ≥3 treatment-related adverse events or signals of drug-induced liver injury [6] Future Development - Sagimet plans to initiate a Phase 3 program for denifanstat in 2024, following the positive results from the Phase 2b trial [4]