眾生藥業(002317.SZ):控股子公司一類創新藥昂拉地韋顆粒II期臨牀試驗獲得頂線分析數據結果
格隆匯5月13日丨眾生藥業(002317.SZ)公佈,公司控股子公司廣東眾生睿創生物科技有限公司(簡稱“眾生睿創”)自主研發的一類創新藥物昂拉地韋顆粒(研發代號:ZSP1273顆粒)治療2~17歲單純性甲型流感患者的II期臨牀試驗,於近日獲得頂線分析數據。初步結果表明,昂拉地韋顆粒在2~17歲單純性甲型流感參與者中表現出積極的療效和良好的安全性,試驗結果理想,達到預期目的。
本次昂拉地韋顆粒II期臨牀試驗,綜合各項症狀的中位流感症狀緩解時間為31.72小時,其中高劑量組為28.63小時,低劑量組33.65小時;中位發熱緩解時間僅24.07小時,高劑量組為23.47小時,低劑量組為26.03小時。分層分析顯示各年齡段參與者的流感症狀緩解時間和發熱緩解時間相近。
結果顯示,昂拉地韋顆粒治療2~17歲兒童和青少年甲型流感參與者II期臨牀試驗,在中位流感症狀緩解時間、中位發熱緩解時間,數值上均短於成人患者III期對應時間數據;在降低病毒RNA載量,縮短病毒轉陰時間,與成人患者III期對應病毒學數據相當。初步提示,昂拉地韋顆粒治療2~17歲兒童和青少年甲型流感參與者,在臨牀症狀/體徵和病毒學方面取得了積極的有效性結果。
本項臨牀試驗未發生嚴重不良事件,未發生導致暫停、停用藥物或退出試驗的TEAE(治療期間出現的不良事件)。用藥後發生的藥物不良反應主要為消化系統症狀,絕大多數參與者的不良反應無需處理即完全恢復,表明昂拉地韋顆粒在兒童和青少年具有良好的安全性和耐受性。
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