騰盛博藥-B(02137.HK)公佈一項2期研究中期結果：BRII-835與BRII-179聯合療法安全且耐受性良好
格隆匯2月15日丨騰盛博藥-B(02137.HK)發佈公吿，董事會宣佈了一項2期研究的中期結果，研究發現，BRII-835(也稱為VIR-2218)與BRII-179(也稱為VBI-2601)聯合療法安全且耐受性良好，與單獨使用BRII-835或BRII-179相比，聯合療法誘導了更強的抗乙肝表面抗原(“HBsAg”)抗體應答，並改善了HBsAg特異性T細胞應答。所有隊列在治療結束時都實現了HBsAg降低，平均降低-1.7至-1.8 log10 IU/mL。此外，第40周時觀察到在聯合治療隊列中2例受試者HBsAg水平最低降至或低於定量下限，同時觀察到穩健的 HBsAg特異性抗體應答和T細胞應答。
公司正在開發小干擾核糖核酸BRII-835和乙肝病毒(“HBV”)重組蛋白免疫療法BRII-179，作為聯合療法用於HBV感染的功能性治癒。由於既往在1b期研究中發現兩個單藥治療具有互補的作用機制，這項BRII-835與BRII-179聯合用藥的2期研究為如何恢復高度抑制或耗竭的免疫應答提供了重要思路。該研究的進一步試驗數據預計將在今年晚些時候獲得。
該研究的主要研究者、中國香港大學胃腸病與肝病學系主任袁孟峯(Man-Fung Yuen，M.D.、PhD、DSc)教授表示，“目前已獲得的初步數據讓我們備受鼓舞，這些數據進一步明確了BRII-835和BRII-179獨特作用模式相互補的特點，並表明兩種藥物有潛力為慢性HBV患者提供有價值的臨牀獲益。僅在中國，就有8700萬人感染HBV，但該疾病目前尚無有效的功能性治癒療法，目前的標準治療需要患者終身維持治療。持續的功能性治癒可為患者帶來巨大轉變，降低疾病進展風險，並讓患者更大程度上擺脱疾病的限制。我們期待完成這項2期試驗的進一步數據分析。”
公司中國研發主管朱青博士表示，“這項2期研究的初步結果提供了重要的洞察，以支持我們的臨牀策略，與合作伙伴一起發現和探索多種新的聯合治療方法，以提高各HBV患者亞羣實現高功能性治癒率的可能性。作為我們在大中華區領先治療方案的一部分，我們迫切希望繼續推進BRII-835、BRII-179和BRII-877 (也稱為VIR-3434)的開發，並努力將首款能夠實現持續功能性治癒的療法帶到全球最大的HBV市場。”
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