甘莱FXR激动剂ASC42完成美国I期临床试验首例受试者给药
中国上海2020年12月28日—甘莱制药专注于非酒精性脂肪性肝炎(NASH)领域创新药的开发和商业化，是歌礼制药有限公司(香港联交所代码：1672)旗下全资子公司。公司今日宣布，其法尼醇X受体(FXR)激动剂、NASH候选药物ASC42的美国I期临床试验已完成首例受试者给药。
该I期临床试验是一项在美国开展的随机、双盲、安慰剂对照、单剂量与多剂量递增研究，旨在评估ASC42在健康受试者中的安全性、耐受性、药代动力学和药效动力学特征(生物标志物—FGF19和C4)。该试验还研究了食物对ASC42暴露量的影响。
ASC42是一种由甘莱制药完全自主研发的新型高效选择性非甾类FXR激动剂。ASC42作为NASH候选药物已于近日获得美国食品药品监督管理局(FDA)的快速通道资格认定。ASC42口服片剂由甘莱专有制剂技术开发，具有室温下稳定的特点。
歌礼首席科学官何菡萏博士表示：“很高兴能够在2020年启动ASC42美国I期临床试验，这是我们研发进程中一个重要的里程碑。NASH候选药物ASC42是由我们团队完全自主研发，并有望成为同类最佳(best-in-class)的FXR激动剂。”
甘莱制药首席医学官Melissa Palmer博士表示：“作为一种新型FXR激动剂，ASC42在临床前的研究中表现出显著的抗炎症和抗纤维化作用，ASC42可与脂肪酸合成酶(FASN)抑制剂ASC40或甲状腺激素受体β(THR-β)激动剂ASC41联合使用于NASH治疗，临床疗效令人期待。”
关于歌礼
歌礼是一家在香港证券交易所上市(1672.HK)的创新研发驱动型生物科技公司。歌礼致力于病毒性肝炎、脂肪性肝炎和艾滋病三大疾病领域的研发和商业化，满足国内外患者临床需求。在具备深厚专业知识及优秀过往成就的管理团队带领下，歌礼已发展成为一体化平台型公司，涵盖了从新药发现和开发直到生产和商业化的完整价值链。
歌礼目前拥有三个商业化产品和十三个在研产品(其中九个为完全自主研发)。1、病毒性肝炎：(i)乙肝：歌礼专注于乙肝临床治愈创新药物的研发。探索以皮下注射PD-L1抗体ASC22及派罗欣®为基石药物，与其他靶点药物联合的治疗方案，有望为临床治愈乙肝带来重大突破。(ii)丙肝：歌礼成功研发上市两个1类新药戈诺卫®和新力莱®，组成全口服丙肝治疗方案；ASC18固定剂量复方制剂是升级版的丙肝治疗方案，已完成桥接试验。2、非酒精性脂肪性肝炎：歌礼制药有限公司旗下全资子公司甘莱制药专注于非酒精性脂肪性肝炎领域创新药的开发和商业化。甘莱制药有三款分别针对脂肪酸合成酶(FASN)、甲状腺激素受体ß(THR-ß)及法尼醇X受体(FXR)的处于临床阶段的候选药物及三种处于临床前阶段的联合用药疗法。3、艾滋病：ASC09F是一种用于治疗HIV的蛋白酶固定剂量复方抑制剂，ASC09F的临床试验申请已获得批准。欲了解更多信息，请登录网站：www.ascletis.com。
来源：歌礼官微
原标题：甘莱FXR激动剂ASC42完成美国I期临床试验首例受试者给药
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