Policy & Regulation
Ascletis Pharma initiates ASC40 (Denifanstat) Phase III clinical trial to treat acne
6 December 2023 -

Ascletis Pharma Inc (HKEX: 1672), a China-based pharmaceutical company announced on Tuesday the initiation of the Phase III clinical trial of fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) for treatment of moderate to severe acne vulgaris.

This Phase III clinical trial is a randomised, double-blind, placebo-controlled, multicentre 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 randomised 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, 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 (1).

The protocol of Phase III clinical trial has been agreed by Center for Drug Evaluation, National Medical Products Administration and obtained the approval from Institutional Review Board of Huashan Hospital, Fudan University.

On 2 May 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.