騰盛博藥-B(02137.HK)：在慢性HBV患者的BRII-179(VBI2601) 2a/2b期臨牀試驗中完成首例患者給藥
格隆匯12月27日丨騰盛博藥-B(02137.HK)宣佈，公司在慢性乙型肝炎病毒(”HBV“)患者的BRII-179(VBI2601) 2a/2b期臨牀試驗中已完成首例患者給藥。據估計，全球有2.9億人患有慢性HBV感染，且每年有近80萬人死於與HBV相關肝硬化、肝衰竭和肝癌等併發症。
BRII-179(VBI-2601)是一種新型的基於重組蛋白的HBV免疫治療候選藥物，能夠表達Pre-S1、Pre-S2和S乙肝表面抗原，旨在增強B細胞和T細胞免疫。BRII-179(VBI-2601)的抗原成分與VBI Vaccines Inc.(一家於納斯達克全球市場上市，股票代碼為VBIV的公司)開發的的預防性乙型肝炎重組疫苗PreHevbrio™的三個抗原成分相同，PreHevbrio™已在美國獲批上市。
該項BRII-179的2a/2b期試驗為一項雙盲、隨機、安慰劑對照、平行組研究，目的是在非肝硬化慢性HBV感染者中評價在現有標準治療(聚乙二醇化干擾素－α(PEG-IFN-α)和核苷(酸)類逆轉錄酶抑制(”NrtI“))中，加入BRII-179(VBI-2601)後的臨牀療效。參與研究的患者需要符合預先定義的各項入組指標，即對正在接受的PEG-IFN-α和NrtI治療已實現部分HBsAg應答。獨立的數據和安全監查委員會將審查該研究患者的安全性和有效性數據。
於BRII-179的2a期試驗中，該研究將在約120名患者中確定BRII-179(VBI-2601)聯合PEG-IFN-α + NrtI治療的有效性及安全性。2a期試驗的主要終點為治療完成時達到HBsAg清除的患者百分比。
在BRII-179(VBI-2601)治療的2b期試驗中，該研究將擴展至480名患者，旨在評價接受聯合使用PEG-IFN-α + NrtI的BRII-179(VBI-2601)治療後達到功能性治癒的患者百分比。2b期試驗的主要終點是達到HBsAg和HBV DNA持續清除的患者百分比。
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