喜訊！甘萊FXR激動劑ASC42獲美國FDA快速通道資格認定
2020年12月14日，歌禮制藥有限公司(香港聯交所代碼：1672)旗下全資子公司甘萊(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)宣佈，美國食品和藥品監督管理局(FDA)授予公司NASH候選藥物ASC42快速通道資格。
美國FDA的快速通道項目旨在加速針對嚴重疾病的藥物開發和快速審查，以解決未獲滿足的醫療需求。目前，尚無獲得美國FDA批准的NASH藥物。ASC42能順利獲得快速通道資格認定，表明美國FDA認可其有解決NASH患者未被滿足的醫療需求的潛力。
ASC42於今年10月獲得美國FDA批准在NASH患者中開展臨牀試驗。ASC42是一種完全自主研發的、有望成為同類最佳(best-in-class)的新型高效選擇性非甾類法尼醇X受體(FXR)激動劑。在兩個NASH動物模型中，ASC42表現出了對肝臟脂肪變性、炎症和纖維化的顯著改善。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。
吳勁梓博士表示：“我們很高興美國FDA授予了ASC42快速通道資格，這是由我們優秀研發團隊完全自主研發的FXR激動劑。ASC42是一款有望成為同類最佳(best-in-class)的FXR激動劑，此次美國FDA授予快速通道資格將加速ASC42的全球研發進程。”
甘萊在其NASH管線中還有兩款處於臨牀階段的候選藥物，分別為ASC40和ASC41。ASC40(TVB-2640)是一種口服脂肪酸合成酶(FASN)抑制劑，在美國開展的Ⅱ期臨牀(FASCINATE-1)數據顯示ASC40(TVB-2640)顯著降低了肝臟脂肪含量，在50mg劑量組中應答率高達61%。ASC41是一種前體藥物，具有肝臟靶向性，其活性成分(ASC41-A)對THR-β具有選擇性，目前處於Ⅰ期臨牀階段。除了以上三款分別針對三個不同靶點的處於臨牀階段的候選藥物以外，甘萊還有三種處於臨牀前階段的聯合用藥療法，分別為ASC40/ASC42、ASC41/ASC42和ASC40/ASC41聯合用藥療法。
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