歌礼制药-B(01672.HK)完成ASC42慢性乙型肝炎(CHB)适应症II期临床试验首例患者给药
格隆汇1月11日丨歌礼制药-B(01672.HK)发布公告，公司已完成ASC42慢性乙型肝炎(CHB)适应症的II期临床试验首例患者给药。
根据披露，该II期临床试验(临床试验编号：NCT05107778)是一项多中心、随机、单盲、安慰剂对照的中国临床试验，以评估ASC42片与恩替卡韦和聚乙二醇干扰素α-2a联用在慢性乙型肝炎患者中的安全性和有效性。约45名慢性乙型肝炎患者将入组并接受一日一次口服ASC42片(10 mg或15 mg)或安慰剂，并与恩替卡韦(0.5 mg，口服一日一次)和聚乙二醇干扰素α-2a(180 μg，皮下注射一周一次)联合治疗12周，在12周治疗期和24周随访期内，检测血清乙肝表面抗原(HBsAg)和乙肝病毒(HBV)前基因组RNA (pgRNA)相较基线的变化。
ASC42是一款由公司完全自主研发、有望成为同类最佳的新型高效选择性非甾类法尼醇X受体(FXR)激动剂。ASC42美国I期临床试验(临床试验编号：NCT04679129)表明，在人体有效剂量15 mg、一日一次、为期14天的治疗过程中，未观察到瘙痒症状，且低密度脂蛋白胆固醇(LDL-C)维持正常水平。同时，FXR靶向激活的生物标志物成纤维细胞生长因子19(FGF19)在给药第14天时的增幅高达1,780%，7α-羟基-4-胆甾烯-3-酮(C4)在给药第14天时的降幅高达91%。
作为一款FXR激动剂，ASC42对乙肝病毒(HBV)具有独特的作用机制：ASC42可抑制HBV cccDNA转录为HBV RNA，进而抑制HBV RNA翻译为HBsAg。同时，ASC42可能会降低HBV cccDNA的稳定性。体外人原代肝细胞(PHH)研究和小鼠腺相关病毒介导的乙肝病毒(AAV-HBV)感染研究均显示，ASC42对HBsAg和 HBV pgRNA具有显著的抑制作用，表明ASC42有望实现慢性乙型肝炎功能性治愈。
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