By: IPP Bureau
Last updated : January 23, 2024 10:57 am
Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial
Gannex Pharma Company Ltd (Gannex), a wholly-owned company of Ascletis Pharma, announced that its strategic partner, Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), today reported positive topline results from Sagimet's FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with stage 2 or stage 3 fibrosis (F2/F3) at week 52.
In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis.
Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of NASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.