ASCLETIS-B (01672) announced that it presented the Phase III study results of denifanstat (ASC40) for treating moderate to severe acne vulgaris (NCT06192264) in an oral presentation at the breakthrough research session of the 2025 European Academy of Dermatology and Venereology (EADV) Annual Meeting held in Paris, France on September 17, 2025.
"Denifanstat (ASC40) represents an innovative therapeutic approach in acne treatment with potential clinical significance. We are honored to present these results to the dermatology community at this EADV meeting," stated Dr. Wu Jinzi, Founder, Chairman and Chief Executive Officer of ASCLETIS. "Denifanstat (ASC40) employs a novel mechanism of action for acne treatment and demonstrated highly statistically significant and clinically meaningful improvements across all primary and secondary endpoints compared to placebo in the Phase III study, while showing favorable safety and tolerability profiles."
ASCLETIS is currently conducting pre-New Drug Application (Pre-NDA) communications with China's National Medical Products Administration (NMPA) for denifanstat (ASC40), and the feedback from NMPA has been positive to date. The company plans to submit a New Drug Application (NDA) to NMPA for denifanstat (ASC40) in treating moderate to severe acne vulgaris upon completion of the pre-NDA communications.
ASCLETIS has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT).