Sagimet receives FDA breakthrough therapy designation for denifanstat

Sagimet Biosciences announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis. Breakthrough Therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 clinical trial in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis. In the trial, denifanstat showed statistically significant improvements relative to placebo on both primary endpoints of MASH resolution without worsening of fibrosis with greater than or equal to2-point reduction in Nonalcoholic Fatty Liver Disease Activity Score, and greater than or equal to2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by greater than or equal to 1 stage with no worsening of MASH, and a statistically significantly greater proportion of MRI-derived proton density fat fraction greater than or equal to30% responders relative to placebo. In the intent to treat population, denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH. Safety data showed that denifanstat was generally well tolerated. The Company plans to initiate the Phase 3 clinical program for denifanstat in MASH by the end of 2024.