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Sagimet Biosciences Inc. ((Sagimet, NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the completion of a Phase 1 hepatic impairment study with denifanstat, a selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
This study was designed to assess the safety and pharmacokinetics of denifanstat in subjects with hepatic impairment, a typical requirement of development programs in MASH. A total of 38 subjects were enrolled and completed this non-randomized, parallel group study. The study population included 8 subjects in each category of mild, moderate or severe hepatic impairment, and 14 healthy subjects with normal hepatic function demographically matched to the subjects with hepatic impairment for age, body weight, and gender. All subjects received oral denifanstat 50 mg once a day for 4 days.
Denifanstat was well-tolerated and no safety signals were reported. The pharmacokinetic results from this study are anticipated to support the planned Phase 3 program for denifanstat in MASH.
Posted In: SGMT
