Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, denifasertib (ASC40), in patients with moderate to severe acne vulgaris [1] Group 1: Study Overview - The Phase III study was conducted in China and involved 240 patients with moderate to severe acne vulgaris [1] - The study aimed to evaluate the long-term safety of denifasertib (ASC40) over a 40-week treatment period, following a 12-week treatment with either denifasertib (ASC40) or placebo [1] Group 2: Safety and Tolerability - Key endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events (AEs) [1] - Denifasertib (ASC40) demonstrated good safety and tolerability, with most adverse events being mild (Grade 1) or moderate (Grade 2) [1] - No Grade 3 or 4 adverse events or serious adverse events related to denifasertib (ASC40) were reported, and there were no reported deaths [1]
歌礼制药-B(01672.HK)：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