First patient dosed in a phase 2 combined therapy trial for chronic HBV

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.”