China-based Ascletis Pharma Inc. (HKG: 1672) announced the completion of enrollment of 180 patients in a Phase II clinical study for ASC40 (denifanstat). The molecule is set to be assessed in treating moderate to severe acne. The study is currently still blinded.
Study Design and Objectives
The randomized, double-blind, placebo-controlled, multicenter clinical trial in China is designed to evaluate the safety and efficacy of ASC40 for the treatment of patients with moderate to severe acne. The 180 enrolled patients have been randomized into three active treatment arms or one placebo control arm at the ratio of 1:1:1:1 to receive ASC40 (25 mg, 50 mg, or 75 mg) or a matching placebo orally once daily for 12 weeks. The primary outcomes include the percentage of change of total lesion count at week 12 compared with baseline and/or the ratio of subjects, whose Investigator’s Global Assessment (IGA) grades are decreased by ≥2 grades at week 12 compared with the baseline. To date, approximately 50% of enrolled patients have completed the 12 weeks of treatment and all enrolled patients are expected to complete the treatment by the end of February 2023. To date, the preliminary data also indicated that ASC40 or placebo treatment in acne patients is safe and well tolerated, and the majority of treatment-related adverse events are grade 1.
ASC40: Mechanism and Development
ASC40 is an oral, selective small-molecule inhibitor of fatty acid synthase (FASN), a key enzyme that regulates de novo lipogenesis (DNL). Human sebum production requires de novo lipogenesis, which is increased in acne and can be suppressed by the FASN inhibitor ASC40. The drug is also undergoing clinical studies in non-alcoholic steatohepatitis (NASH) and tumors.-Fineline Info & Tech
