Clinical Trial Info

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

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This is an open-label, randomized, parallel-group Phase 2 study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in 135 adult participants with chronic HBV infection.

Results

Brii Biosciences (“Brii Bio”) and VBI Vaccines Inc. (“VBI”), announced on June 23, 2021, final results from a Phase 1b/2a study on BRII-179 (VBI-2601), a novel recombinant, protein-based immunotherapeutic candidate, in patients with chronic hepatitis B virus (HBV) infection.

Data from the study, which evaluated the safety, antiviral activity, and immunogenicity of BRII-179 (VBI-2601) alone or admixed with interferon-alpha (IFN-α) as co-adjuvant, demonstrated that the investigational immunotherapeutic induced both B cell (antibody) and T cell responses, and was well-tolerated with no safety signals observed, in non-cirrhotic chronic hepatitis B patients under nucleotide analog (NUC) therapy. The study was led by Brii Bio in partnership with VBI.