Phase III trial enrolled a total of 480 patients with moderate to severe acne
-Topline results expected in the second quarter 2025

Ascletis Pharma Inc. announces completion of enrollment of 480 patients for Phase III clinical trial of ASC40 (denifanstat) once-daily oral tablet for treatment of moderate to severe acne. The first patient was enrolled on January 24, 2024.

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 once-daily oral tablet for the treatment of moderate to severe acne vulgaris. 480 patients with moderate to severe acne vulgaris were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg ASC40 oral tablet once daily or matching placebo for 12 weeks. Topline results are expected in the second quarter 2025.

The primary efficacy endpoints are the proportion of patients achieving treatment success at week 12, the percentage change from baseline in total lesion count at week 12, and the percentage change from baseline in inflammatory lesion count 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).

On May 2, 2023, Ascletis announced that the Phase II clinical trial for ASC40 once-daily oral tablet for the treatment of acne vulgaris met the primary and key secondary endpoints, demonstrating superior efficacy including 19.4% patients achieving treatment success at week 12 versus placebo (5.1%) and a good safety profile (Link).

ASC40 is a first-in-class, once-daily 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.  ASC40 is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China.

"As a first-in-class once-daily oral drug candidate with novel mechanism for acne treatment, ASC40 has shown positive efficacy and a good safety profile in the Phase II study. We look forward to announcing topline results of the ASC40 (denifanstat) Phase III trial in the second quarter 2025." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.