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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
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the oral presentation of the Phase III study results of denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris (NCT06192264) was presented in the Late Breaking News sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025.
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"--Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne compared with placebo.","length":174,"tagName":"p"},{"type":"text","content":"--Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Treatment emergent adverse events (TEAEs) in the denifanstat (ASC40) group were comparable to placebo: 58.6% versus 56.3%. The majority of TEAEs were mild (Grade 1) or moderate (Grade 2).","length":267,"tagName":"p"},{"type":"text","content":"--Pre-New Drug Application (NDA) consultation of denifanstat (ASC40) with the China National Medical Products Administration (NMPA) is ongoing and feedback received from NMPA so far is encouraging. Ascletis plans to submit an NDA for denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris to NMPA after completing its pre-NDA consultation. ","length":358,"tagName":"p"},{"type":"text","content":"HONG KONG, Sept. 17, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the oral presentation of the Phase III study results of denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris (NCT06192264) was presented in the Late Breaking News sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025.","length":427,"tagName":"p"},{"type":"text","content":"Details of the Oral Presentation","length":32,"tagName":"p"},{"type":"text","content":"Title: First-in-Class FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne Vulgaris: Results from a Phase Ⅲ Randomised Placebo Controlled Trial","length":170,"tagName":"p"},{"type":"text","content":"Presenter: Dr. Leihong (Flora) XIANG, M.D and Ph.D., Principal Investigator of denifanstat (ASC40) Phase III study, Department of Dermatology, Huashan Hospital, Fudan University","length":177,"tagName":"p"},{"type":"text","content":"The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat (ASC40) once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to ...