Chinese pharmaceutical company Ascletis Pharma Inc (HKEX:1672) announced on Wednesday that the oral presentation of the Phase III study results of denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris was presented in the Late Breaking News sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on 17 September 2025.

The randomised, double-blind, placebo-controlled, multicentre Phase III clinical trial in China was designed 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 randomised 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 showed statistically significant improvements (p