Sagimet Biosciences announces Phase 2b FASCINATE trial met primary endpoint

Sagimet Biosciences announced that results from the Phase 2b FASCINATE-2 clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic-dysfunction associated steatohepatitis. MASH, patients with stage 2 or stage 3 fibrosis were published in The Lancet Gastroenterology & Hepatology. The publication reports that denifanstat showed statistically significant improvements at week 52 relative to placebo on both of the primary endpoints: MASH resolution without worsening of fibrosis with greater than or equal to2-point reduction in NAS, and greater than or equal to2-point reduction in NAS without worsening of fibrosis. Denifanstat achieved statistical significance in the intention to treat population as well as in the modified intention to treat population for primary and secondary histology endpoints including MASH resolution with no worsening of fibrosis and fibrosis improvement without worsening of steatohepatitis.