Ascletis Pharma Inc. has announced that its Phase III clinical trial for denifanstat (ASC40), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, has met all primary, key secondary, and secondary endpoints for the treatment of moderate to severe acne vulgaris. The randomized, double-blind, placebo-controlled, multicenter trial conducted in China involved 480 patients. Denifanstat demonstrated a statistically significant improvement in treatment outcomes, with a 33.2% treatment success rate and reductions in total, inflammatory, and non-inflammatory lesion counts by 57.4%, 63.5%, and 51.9% respectively, compared to baseline. The trial results indicate that denifanstat was more effective than several FDA-approved acne treatments in placebo-adjusted percent treatment success. The drug maintained a favorable safety and tolerability profile throughout the study. Ascletis plans to submit the treatment for approval by the China National Medical Products Administration (NMPA).