Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025

Core Insights - Denifanstat (ASC40) has met all primary, key secondary, and secondary efficacy endpoints in treating moderate-to-severe acne compared to placebo [1][6][11] - The drug demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [1][9] Efficacy Results - The Phase III clinical trial involved 480 patients, randomized into treatment and placebo groups, showing significant improvements in multiple efficacy endpoints after 4 weeks and 12 weeks of treatment [4][6] - Primary endpoints included a treatment success rate of 33.17% for denifanstat compared to 14.58% for placebo, with a p-value of <0.0001 [5][6] - Percent reductions from baseline to week 12 in total lesion count (TLC) and inflammatory lesion count (ILC) were 57.38% and 63.45% for denifanstat, respectively, both statistically significant [6][7] Safety Profile - The incidence of TEAEs was 58.6% for denifanstat and 56.3% for placebo, with most events being mild or moderate [9] - Notable TEAEs included 6.3% dry skin and 5.9% xerophthalmia in the denifanstat group, with no serious adverse events reported [9] Regulatory Progress - Ongoing pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) has yielded encouraging feedback, with plans to submit an NDA for denifanstat after consultation completion [2][11] Company Background - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced drug discovery platforms [13]