甘萊FXR激動劑ASC42完成美國I期臨牀試驗首例受試者給藥
中國上海2020年12月28日—甘萊製藥專注於非酒精性脂肪性肝炎(NASH)領域創新藥的開發和商業化，是歌禮制藥有限公司(香港聯交所代碼：1672)旗下全資子公司。公司今日宣佈，其法尼醇X受體(FXR)激動劑、NASH候選藥物ASC42的美國I期臨牀試驗已完成首例受試者給藥。
該I期臨牀試驗是一項在美國開展的隨機、雙盲、安慰劑對照、單劑量與多劑量遞增研究，旨在評估ASC42在健康受試者中的安全性、耐受性、藥代動力學和藥效動力學特徵(生物標誌物—FGF19和C4)。該試驗還研究了食物對ASC42暴露量的影響。
ASC42是一種由甘萊製藥完全自主研發的新型高效選擇性非甾類FXR激動劑。ASC42作為NASH候選藥物已於近日獲得美國食品藥品監督管理局(FDA)的快速通道資格認定。ASC42口服片劑由甘萊專有製劑技術開發，具有室温下穩定的特點。
歌禮首席科學官何菡萏博士表示：“很高興能夠在2020年啟動ASC42美國I期臨牀試驗，這是我們研發進程中一個重要的里程碑。NASH候選藥物ASC42是由我們團隊完全自主研發，並有望成為同類最佳(best-in-class)的FXR激動劑。”
甘萊製藥首席醫學官Melissa Palmer博士表示：“作為一種新型FXR激動劑，ASC42在臨牀前的研究中表現出顯著的抗炎症和抗纖維化作用，ASC42可與脂肪酸合成酶(FASN)抑制劑ASC40或甲狀腺激素受體β(THR-β)激動劑ASC41聯合使用於NASH治療，臨牀療效令人期待。”
關於歌禮
歌禮是一家在香港證券交易所上市(1672.HK)的創新研發驅動型生物科技公司。歌禮致力於病毒性肝炎、脂肪性肝炎和艾滋病三大疾病領域的研發和商業化，滿足國內外患者臨牀需求。在具備深厚專業知識及優秀過往成就的管理團隊帶領下，歌禮已發展成為一體化平台型公司，涵蓋了從新藥發現和開發直到生產和商業化的完整價值鏈。
歌禮目前擁有三個商業化產品和十三個在研產品(其中九個為完全自主研發)。1、病毒性肝炎：(i)乙肝：歌禮專注於乙肝臨牀治癒創新藥物的研發。探索以皮下注射PD-L1抗體ASC22及派羅欣®為基石藥物，與其他靶點藥物聯合的治療方案，有望為臨牀治癒乙肝帶來重大突破。(ii)丙肝：歌禮成功研發上市兩個1類新藥戈諾衞®和新力萊®，組成全口服丙肝治療方案；ASC18固定劑量複方製劑是升級版的丙肝治療方案，已完成橋接試驗。2、非酒精性脂肪性肝炎：歌禮制藥有限公司旗下全資子公司甘萊製藥專注於非酒精性脂肪性肝炎領域創新藥的開發和商業化。甘萊製藥有三款分別針對脂肪酸合成酶(FASN)、甲狀腺激素受體ß(THR-ß)及法尼醇X受體(FXR)的處於臨牀階段的候選藥物及三種處於臨牀前階段的聯合用藥療法。3、艾滋病：ASC09F是一種用於治療HIV的蛋白酶固定劑量複方抑制劑，ASC09F的臨牀試驗申請已獲得批准。欲瞭解更多信息，請登錄網站：www.ascletis.com。
來源：歌禮官微
原標題：甘萊FXR激動劑ASC42完成美國I期臨牀試驗首例受試者給藥
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