歌禮制藥-B(01672.HK)宣佈口服小分子IL-17抑制劑ASC50治療銀屑病的新藥臨牀試驗申請獲美國FDA批準
格隆匯5月22日丨歌禮制藥-B(01672.HK)宣佈其治療輕中度斑塊狀銀屑病的ASC50的I期新藥臨牀試驗申請(IND)已於近期獲美國食品藥品監督管理局(FDA)批準。ASC50爲歌禮自主研發的口服小分子白細胞介素-17(IL-17)靶向抑制劑,該靶點在銀屑病等多種自身免疫及炎症性疾病領域已獲充分的生物學驗證並具備成熟商業價值。
在非人靈長類動物(NHPs)中口服給藥後,與當前正處於臨牀開發階段的某口服小分子IL-17抑制劑相比,ASC50的藥物暴露量更高,半衰期更長以及清除率更低。此外,在銀屑病動物模型中,ASC50顯示出強藥效。這些臨牀前數據支持ASC50有望成爲每日一次口服治療銀屑病的同類最佳(best-in-class)候選藥物。
ASC50的該項I期臨牀試驗爲隨機、雙盲、安慰劑對照的研究,將在美國多箇中心開展,預計將於2025年第三季度開始在輕中度斑塊狀銀屑病人中給藥。
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