Ascletis Pharma announces dosing of the first patient in Phase III clinical trial of ASC40 (Denifanstat) for treatment of moderate to severe acne vulgaris at Huashan Hospital, Fudan University.

This Phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of ASC40 for the treatment of moderate to severe acne vulgaris. 480 subjects with moderate to severe acne vulgaris will be enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg ASC40 or matching placebo orally, once daily for 12 weeks.

The co-primary efficacy endpoints are: proportion of subjects achieving treatment success at week 12, percentage change from baseline in total lesion count at week 12, and percentage change from baseline in inflammatory lesion count (ILC) at week 12. Treatment success is defined as at least a 2-point reduction in Investigator's Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear.

On May 2, 2023, Ascletis announced that ASC40 achieved primary and key secondary endpoints in the Phase II clinical trial for the treatment of acne vulgaris, demonstrating superior efficacy and good safety.

ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of ASC40 for treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Ascletis holds the rights to develop, manufacture and commercialize ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc.

"Our team has once again demonstrated strong execution in advancing promising treatment for patients as this rapid progress has been made since we announced the initiation of Phase III study of ASC40 for acne on December 5, 2023.  As a first-in-class drug candidate with novel mechanism for acne treatment, ASC40 has shown significant efficacy and good safety in the Phase II study. We will accelerate the patient enrollment and expect to report the Phase III results in the near future." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.