Sagimet Biosciences Inc. has obtained IND clearance from the FDA for TVB-3567 (ASC-60), a selective small-molecule fatty acid synthase (FASN) inhibitor set to enter clinical development for the treatment of acne. A first-in-human phase I trial of TVB-3567 in individuals with or without acne is expected to begin this year.
Fatty acid synthase (FASN), an enzyme that drives de novo lipogenesis, plays a relevant role in metabolic disorders such as obesity, non-alcoholic fatty liver disease (NAFLD) or type 2 diabetes. Denifanstat (TVB-2640), a FASN inhibitor, has recently shown positive results in a phase II study in patients with metabolic dysfunction-associated steatohepatitis (MASH).