Ascletis Pharma's denifanstat shows strong phase III results for acne

Ascletis Pharma Inc. presented positive phase III clinical trial results for denifanstat (ASC40) at the European Academy of Dermatology and Venereology (EADV) Congress 2025. The study, involving 480 patients, showed denifanstat met all primary, key secondary, and secondary efficacy endpoints. Treatment success was achieved in 33.17% of patients in the denifanstat group compared to 14.58% in the placebo group.

The percent reduction from baseline in total lesion count was 57.38% for denifanstat versus 35.42% for placebo, and in inflammatory lesion count, it was 63.45% versus 43.21%, all with a P-value of <0.0001.

The drug demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo (58.6% vs. 56.3%). The majority of TEAEs were mild or moderate, and no denifanstat-related Grade 3 or 4 TEAEs, serious AEs, or deaths were reported.

Pre-New Drug Application (NDA) consultation with China's NMPA is ongoing and feedback has been encouraging, with Ascletis planning to submit an NDA for denifanstat (ASC40) for moderate-to-severe acne vulgaris. Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China.