Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne

Core Viewpoint - Sagimet Biosciences Inc. has received clearance for its Investigational New Drug (IND) application for TVB-3567, a fatty acid synthase (FASN) inhibitor, which is set to enter clinical trials for acne treatment in 2025 [2][3]. Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [5]. - The company's lead drug candidate, denifanstat, is an oral FASN inhibitor in development for metabolic dysfunction associated with steatohepatitis (MASH) [5]. Product Development - TVB-3567 is a potent and selective small molecule FASN inhibitor aimed at treating acne, addressing the condition's primary contributor, sebum production [2][3]. - The planned Phase 1 clinical trial for TVB-3567 will be randomized, double-blind, and placebo-controlled, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics [4]. Market Opportunity - Over 50 million people in the US suffer from acne, making it a prevalent skin disease [3]. - FASN inhibition is seen as a significant therapeutic target for acne, with the potential for a differentiated treatment option if approved [3].