第一位在慢性乙肝联合治疗的2期临床试验中服药的患者

StephenW

First patient dosed in a phase 2 combined therapy trial for chronic HBV
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Brii Biosciences, Vir Biotechnology and VBI Vaccines announced the first patient dosed in a phase 2 trial evaluating combination therapy for the treatment of patients with chronic hepatitis B infection, according to a press release.

This multi-center, randomized, open-label study will evaluate the safety and efficacy of BRII-835 (VIR-2218), an investigational small interfering RNA targeting HBV, combined with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, compared with BRII-835 alone. A prior study revealed both agents demonstrated proof of mechanism in HBV patients.

“We believe that a functional cure for HBV is possible and will require restoration of HBV-specific immunologic control in addition to viral suppression mechanisms. Data from our previous study suggest BRII-179 (VBI-2601) was able to restimulate both antibody and T-cell responses specific to HBV,” Francisco Diaz-Mitoma, MD, PHD, chief medical officer of VBI Vaccines, said in the release. “This combination study represents the first combination of a therapeutic HBV vaccine to restore HBV-immunity with antivirals designed to reduce the levels of HBV surface antigens.”

StephenW

第一位在慢性乙肝联合治疗的2期临床试验中服药的患者
已添加到电子邮件提醒

根据新闻稿，Brii Biosciences，Vir Biotechnology和VBI Vaccines宣布了第二期试验中的首位患者，该试验评估了联合疗法对慢性乙型肝炎患者的治疗。

这项多中心，随机，开放标签的研究将评估BRII-835（VIR-2218）（一种针对HBV的研究性小干扰RNA）与BRII-179（VBI-2601）（一种研究性HBV免疫疗法）的安全性和有效性，与单独的BRII-835相比。先前的研究表明，这两种药物均证明了HBV患者的机制。

“我们认为功能性治愈HBV是可能的，除病毒抑制机制外，还需要恢复HBV特异性免疫控制。来自我们先前研究的数据表明BRII-179（VBI-2601）能够重新刺激针对HBV的抗体和T细胞反应， 。 “这项组合研究代表了一种治疗性HBV疫苗的首次组合，该疫苗可恢复旨在降低HBV表面抗原水平的抗病毒剂，从而恢复HBV免疫力。