By Fineline Cube 
China-based Ascletis Pharma Inc. (HKG: 1672) announced that the Phase III clinical study of its denifanstat (ASC40), a first-in-class FASN inhibitor, has achieved all primary and secondary endpoints in moderate to severe acne vulgaris. The study demonstrated a 33.2% treatment success rate compared to 14.6% for placebo at week 12.
Clinical Trial Results
The trial enrolled 480 patients and showed significant reductions in total skin lesions, inflammatory skin lesions, and non-inflammatory skin lesions. Denifanstat also exhibited a favorable safety and tolerability profile, with adverse event rates comparable to placebo, both mild to moderate. No drug-related serious adverse events or deaths were reported.
Mechanism of Action
Denifanstat works by inhibiting fatty acid synthesis in sebaceous cells, reducing facial sebum secretion. It also targets key pathogenic mechanisms of acne by inhibiting cytokine secretion and Th17 differentiation to suppress inflammatory responses.
Market Filing
Ascletis Pharma plans to submit a market filing for denifanstat to China’s National Medical Products Administration (NMPA) soon.-Fineline Info & Tech