歌礼制药-B：同类首创每日一次口服FASN抑制剂地尼法司他(ASC40)治疗痤疮的III期开放标签研究取得积极顶线结果

Core Insights - The company announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule FASN inhibitor, ASC40, for moderate to severe acne patients [1][2] - ASC40 demonstrated good safety and tolerability, with most adverse events being mild to moderate, and no severe adverse events reported [1] - The unique mechanism of action of ASC40 directly reduces sebum production, addressing one of the main causes of acne, which differentiates it from other acne treatments [2] Group 1 - The Phase III study involved 240 moderate to severe acne patients who received 40 weeks of daily ASC40 treatment after a 12-week period of either ASC40 or placebo [1] - The primary endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events [1] - No deaths were reported during the study, indicating a favorable safety profile for ASC40 [1] Group 2 - A separate Phase III randomized, double-blind, placebo-controlled study involving 480 patients also met all primary, key secondary, and secondary endpoints [2] - ASC40's mechanism involves inhibiting de novo lipogenesis (DNL) in human sebocytes, directly reducing sebum production and inflammation [2] - The company has obtained exclusive rights for ASC40 in the Greater China region from Sagimet Biosciences Inc. [2]