Ascletis Finishes Phase III Trial Enrollment for Daily ASC40 Acne Treatment

Ascletis Pharma Inc. recently announced the successful enrollment of 480 patients in a Phase III clinical trial for their drug ASC40 (denifanstat), which is being developed as a once-daily oral treatment for moderate to severe acne. The first patient was enrolled on January 24, 2024. The trial is being conducted in China and is designed to assess the safety and efficacy of ASC40 in treating acne vulgaris.

This Phase III trial is a randomized, double-blind, placebo-controlled, multicenter study. The 480 patients enrolled have been divided into two groups: one receiving the active treatment and the other receiving a placebo. Each group receives a 50 mg dose of ASC40 or a matching placebo once daily for a duration of 12 weeks. The expected date for the release of topline results is in the second quarter of 2025.

The primary efficacy endpoints for the trial include the proportion of patients who achieve treatment success by 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 specifically defined as at least a 2-point reduction in the Investigator’s Global Assessment (IGA) score from baseline, as well as achieving a score of either clear (0) or almost clear (1).

In May 2023, Ascletis reported that their Phase II clinical trial of the ASC40 tablet for treating acne vulgaris had met its primary and key secondary endpoints. The results demonstrated superior efficacy, with 19.4% of patients achieving treatment success at week 12 compared to 5.1% in the placebo group, along with a favorable safety profile.

ASC40 operates through two main mechanisms. First, it inhibits facial sebum production by blocking de novo lipogenesis (DNL) in human sebocytes. Second, it reduces inflammation by decreasing cytokine secretion and Th17 differentiation. ASC40 is a first-in-class, once-daily oral selective small molecule inhibitor of fatty acid synthase (FASN). This drug is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China.

Dr. Jinzi J. Wu, Founder, Chairman, and CEO of Ascletis, expressed optimism about the drug’s potential. He highlighted the positive efficacy and good safety profile demonstrated in the Phase II study and looked forward to the Phase III trial results expected in the second quarter of 2025.

Ascletis Pharma Inc. is a biotech company listed on the Hong Kong Stock Exchange, focusing on innovative research and development. The company covers the entire value chain from discovery and development to GMP manufacturing. The management team at Ascletis has deep expertise and a proven track record, enabling rapid advancement of its drug pipeline. The company concentrates on two therapeutic areas with significant unmet medical needs: metabolic diseases and viral diseases. It has multiple clinical-stage drug candidates in its R&D pipeline.

Ascletis continues to push the boundaries of pharmaceutical innovation, with ASC40 being one of its promising candidates for addressing acne vulgaris. As the company progresses through the final stages of clinical testing, the potential approval of ASC40 could provide a novel and effective treatment option for those suffering from moderate to severe acne.