Ascletis Initiates Phase III Trial for ASC40 in Acne Vulgaris

Ascletis Pharma Inc. was the first patient enrolled in a Phase 3 clinical trial of ASC40 (Denifanstat) to treat moderate to severe acne vulgaris at Fudan Huashan University Hospital.

This phase 3 clinical trial is a randomized, double-masked, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of ASC40 for treating mild to severe acne vulgaris. Four hundred eighty patients with moderate to severe acne vulgaris were enrolled and assigned in a 1:1 ratio to an active treatment group and a placebo control group to receive 50 mg of ASC40 and compared to the identical placebo every day for 12 weeks. The primary efficacy endpoints were the proportion of subjects achieving treatment success at week 12, the percent change from baseline in total stroke score at week 12, and the percent change in inflammatory lesion count (ILC) log at week 12. Treatment success was defined as a decrease in the Interrogator and Global Assessment (IGA) score of at least 2 points from baseline, with clear (0) or almost precise (1) scores.

On May 2, 2023, Ascletis announced that ASC40 met primary and secondary endpoints in a Phase 2 clinical trial for treating acne vulgaris, showing good efficacy and improved safety.

ASC40 is an orally selective small molecule inhibitor of fatty acid synthase (FASN). ASC40's mechanisms for acne treatment include (1) direct inhibition of facial sebum production by inhibiting de novo lipogenesis (DNL) in human sebocytes; (2) Suppress inflammation by reducing cytokine secretion and Th17 differentiation. Ascletis has the right to develop, manufacture and market ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc