康哲藥業(00867.HK)創新產品CF102的II期NASH研究取得積極頂線結果
2020年4月7日,Can-Fite Bio Pharma Ltd宣佈其產品CF102針對非酒精性脂肪性肝病(NAFLD)/非酒精性脂肪性肝炎(NASH)的II期探索性研究已達到其療效終點,同時證明其良好的安全性。這項II期雙盲、安慰劑對照、劑量探索療效和安全性研究納入60例NAFLD伴或不伴NASH患者,研究地點為以色列的三個臨牀點,包括耶路撒冷的Hadassah醫學中心、以色列Rabin醫療中心、拿撒勒的Holy Family醫院。本次主要研究終點為劑量依賴性,並且達到顯著水平,實驗表明CF102具有良好的治療效果,是NAFLD/NASH臨牀治療中持續且強有力的候選藥物。

NAFLD是全球最常見的慢性肝病,NAFLD疾病譜包括非酒精性肝脂肪變、NASH等。普通成人NAFLD患病率在6.3%-45%,其中10%-30%為NASH。中國在內的亞洲多數國家NAFLD患病率處於中上水平(>25%),已經趕超歐美等發達國家並已成為我國肝病和代謝領域的新挑戰,對國民健康和社會發展構成嚴重威脅。相信一旦CF102經過嚴格的臨牀試驗證實,將為患者提供一種全新的治療選擇。
康哲藥業(867.HK)已於2018年8月通過其全資附屬公司從Can-Fite獲得了產品CF101及CF102在大中華地區的相關產品權利。
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