歌禮制藥-B(01672.HK)合作伙伴Sagimet完成中重度纖維化NASH患者IIb期臨牀試驗的首例給藥
格隆匯8月16日丨歌禮制藥-B(01672.HK)宣佈其合作伙伴Sagimet Biosciences Inc.("Sagimet")已完成其非酒精性脂肪性肝炎(NASH) IIb期臨牀試驗(FASCINATE-2)首例患者給藥。
FASCINATE-2是一項隨機、雙盲、安慰劑對照的IIb期臨牀試驗，共入組約330名伴有中重度纖維化(F2-F3)的NASH患者。該試驗將通過活檢評估每日口服一次TVB-2640 (ASC40)的療效，治療週期為52周。患者將隨機接受安慰劑治療或50mg TVB-2640 (ASC40)治療。計劃在完成12周開放標籤隊列IIa期臨牀試驗(FASCINATE-1)後，將75mg TVB-2640 (ASC40)加入IIb期臨牀試驗(FASCINATE-2)。
主要療效終點：
1. 非酒精性脂肪性肝病(NAFLD)活動評分(NAS)改善≥ 2分(炎症或氣球樣變改善)；或
2. 纖維化的改善。
美國食品藥品監督管理局(FDA)已批准該NASH IIb期研究的兩個主要療效終點。此外肝臟活檢數據也將用於評估在纖維化不惡化的情況下NASH組織病理學改善，或在NASH症狀不惡化的情況下，對纖維化程度的改善。這兩種情況均為FDA認可的加速批准III期研究的終點。該試驗還將在中期分析中測量通過磁共振成像質子密度脂肪含量(MRI-PDFF)測定的肝臟脂肪含量，以及部分患者在26周時的炎症、纖維化和肝臟損傷的其他血清生物標誌物。
2021年3月，公司全資附屬公司甘萊製藥有限公司和Sagimet共同宣佈每日口服一次的脂肪酸合成酶(FASN)抑制劑ASC40(國外代號為TVB-2640)在隨機、安慰劑對照II期臨牀試驗的中國隊列中取得良好頂線數據。初步數據顯示，ASC40顯着地減少了肝臟脂肪，這是該試驗的主要療效終點，有50%的應答率(患者肝臟脂肪含量減少≥30%)。參與者的ALT(一種與炎症有關的肝臟酶)也有明顯改善。這些來自中國隊列的數據與美國隊列的數據一致。
公司全資附屬公司歌禮生物科技(杭州)有限公司及其聯屬公司擁有脂肪酸合成酶(FASN)抑制劑包括ASC40 (TVB-2640)及所有相關化合物的所有適應症包括非酒精性脂肪性肝炎(NASH)和腫瘤等在大中華區開發、製造和商業化的獨家權益。
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