騰盛博藥-B(02137.HK)在2024年歐洲肝臟研究協會大會上發佈了兩項2期研究的新數據
格隆匯6月7日丨騰盛博藥-B(02137.HK)公吿,公司在2024年歐洲肝臟研究協會大會上發佈了兩項2期研究的新數據,這些數據評估了BRII-179與BRII-835(elebsiran)聯合療法或BRII-179作為疊加療法聯合聚乙二醇長效干擾素α(PEG-IFNα)治療慢性乙型肝炎病毒(HBV)感染的有效性。
一項2期臨牀試驗的口頭報吿數據顯示,在部分慢性HBV感染受試者中,治療性疫苗BRII-179與BRII-835(elebsiran)聯合可誘導顯著的HBV特異性B細胞和T細胞應答,這些應答與抗病毒作用相關。這項探索性轉化研究評估了治療誘導的免疫應答與抗病毒效果之間的相關性。
杜克-新加坡國立大學醫學院新興傳染病項目教授、醫學博士Antonio Bertoletti表示:“這項研究首次直接證明了HBV治療性疫苗誘導的免疫應答在部分慢性HBV感染受試者中與HBsAg降低和病毒控制相關。抗病毒活性看上去與BRII-179誘導的抗乙型肝炎病毒表面抗體增強以及Pre-S1特異性T細胞應答有關,證明了BRII-179可以打破免疫耐受,對病毒感染的持續控制產生影響”。
此外,另一項2期臨牀試驗的最新突破壁報展示的數據顯示,與PEG-IFNα組相比,從治療結束(EOT)到核苷(酸)類逆轉錄酶抑制劑(NRTI)停藥後至少24周,在PEG-IFNα的基礎上使用BRII-179可改善總體HBsAg清除率。這些研究的有利風險-獲益特徵和科學洞見將進一步支持BRII-179聯合其他療法(例如小干擾核糖核酸(siRNA)和PEG-IFNα)作為慢性HBV感染治療的關鍵組成部分以實現功能性治癒目標的臨牀評估。
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