–Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne compared with placebo.
–Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Treatment emergent adverse events (TEAEs) in the denifanstat (ASC40) group were comparable to placebo: 58.6% versus 56.3%. The majority of TEAEs were mild (Grade 1) or moderate (Grade 2).
–Pre-New Drug Application (NDA) consultation of denifanstat (ASC40) with the China National Medical Products Administration (NMPA) is ongoing and feedback received from NMPA so far is encouraging. Ascletis plans to submit an NDA for denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris to NMPA after completing its pre-NDA consultation.
HONG KONG, Sept. 17, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that the oral presentation of the Phase III study results of denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris (NCT06192264) was presented in the Late Breaking News sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025.
Details of the Oral Presentation
Title: First-in-Class FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne Vulgaris: Results from a Phase Ⅲ Randomised Placebo Controlled Trial
Presenter: Dr. Leihong (Flora) XIANG, M.D and Ph.D., Principal Investigator of denifanstat (ASC40) Phase III study, Department of Dermatology, Huashan Hospital, Fudan University
The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat (ASC40) once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat (ASC40) oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat (ASC40) and placebo arms.
Primary endpoints included the percent treatment success, defined as an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12, the percent reductions from baseline to week 12 in total lesion count (TLC), and the percent reduction from baseline to week 12 in inflammatory lesion count (ILC).
After 4-week treatment, the denifanstat (ASC40) group already showed statistically significant improvements (p