騰盛博藥-B(02137.HK)在COVID-19新冠門診患者中評估BRII-196和BRII-198聯合療法ACTIV-2試驗三期研究獲得積極數據
格隆匯8月25日丨騰盛博藥-B(02137.HK)發佈公吿，在ACTIV-2試驗的中期分析中，公司的SARS-CoV-2(引起COVID-19的病毒)中和單克隆抗體BRII-196/BRII-198聯合療法(“BRII-196/BRII-198聯合療法”)在837例疾病進展高風險的新冠肺炎(COVID-19)門診患者中，與安慰劑相比，住院及死亡的複合終點降低78%，具有統計學顯著性，相對危險度(RR)：0.22(95%置信區間：0.05，0.86)P值<.00001(未調整，單側檢驗)。在基於837名受試者部分隨訪的中期分析中，觀察到住院(治療組12例及安慰劑組45例)及死亡(治療組1例及安慰劑組9例)人數均有下降。其他亞組分析可能進一步描述在症狀出現後較早期(首發症狀後5天內)使用BRII-196/BRII-198治療相比更晚的(首發症狀後6-10天)使用帶來的臨牀獲益，為制定真實世界治療決策提供獨到的見解。
2/3期ACTIV-2試驗中的BRII-196/BRII-198試驗組由美國國立衞生研究院(“NIH”)下屬的國家過敏和傳染病研究所(“NIAID”)資助，對837例出現症狀後10天內入組的疾病進展高風險的門診患者(年齡≥60歲或任何年齡伴有其他疾病)進行評估。該研究獨立的數據與安全監察委員會(DSMB)在預先設定的審查中完成了對約69%受試者的主要研究終點評估，在明確證明數據具有統計學顯著性後，允許提前公佈此研究結果，同時繼續開展完整的研究隨訪。入組受試者會在治療後28天內評估相較安慰劑，其住院和死亡的主要複合終點。
目前一期及二期臨牀試驗數據顯示BRII-196/BRII-198聯合療法整體具有良好的安全性及耐受性。騰盛博藥於2020年初就攜手清華大學和深圳市第三人民醫院共同成立騰盛華創，以共同開發BRII-196和BRII-198新冠中和抗體。BRII-196/BRII198聯合療法在中國的二期臨牀試驗(NCT04787211)正在進行，並由中國工程院院士、廣州醫科大學附屬第一醫院國家呼吸系統疾病臨牀醫學研究中心主任鍾南山院士牽頭。針對中國近期出現的由德爾塔變異株等引起的COVID-19病例，騰盛博藥已與中國政府機構及醫院開展合作，向廣州、深圳、瑞麗、昆明、南京、揚州、張家界以及鄭州提供BRII-196/BRII-198開展臨牀救治。
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