Core Viewpoint - The company reported positive results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne, demonstrating significant efficacy compared to placebo and good safety and tolerability profiles [1] Group 1: Study Results - Denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints in the intent-to-treat (ITT) analysis, showing significant improvement in moderate to severe acne compared to placebo [1] - The incidence of treatment-emergent adverse events (TEAEs) was comparable between the denifanstat (ASC40) group and the placebo group, at 58.6% versus 56.3% respectively [1] - Most TEAEs were mild (Grade 1) or moderate (Grade 2) [1] Group 2: Regulatory Communication - The company is in pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration (NMPA) in China regarding denifanstat (ASC40) [1] - Feedback from the NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [1]
歌礼制药-B(01672.HK)在2025年EADV年会上报告了同类首创脂肪酸合成酶(FASN)抑制剂地尼法司他(ASC40)治疗痤疮的III期研究结果