Brii Biosciences Ltd (HKG: 2137), a leading biotechnology company based in China, has presented new data from two Phase II clinical studies on BRII-179 at the European Association for the Study of the Liver (EASL) 2024 annual conference. The data confirm the efficacy of BRII-179 in combination with BRII-835 or as a superimposing therapy with polyethylene glycol long-acting interferon alpha (PEG-IFN alpha) for the treatment of chronic hepatitis B virus (HBV).
The first Phase II study indicated that in chronic HBV patients, the combination therapy of BRII-179 and BRII-835 can elicit substantial HBV-specific B and T cell responses, which correlate with antiviral activity. Notably, a significant reduction in hepatitis B virus surface antigen (HBsAg) was observed in some subjects, and the antibodies induced by BRII-179 showed potent neutralizing activity against HBV.
The second Phase II study demonstrated that the addition of BRII-179 to PEG-IFN alpha therapy resulted in improved overall HBsAg clearance compared to PEG-IFN alpha alone. This improvement trend persisted for at least 24 weeks after discontinuation of nucleoside (acid) reverse transcriptase inhibitors (NRTI) or 36 weeks post-treatment. The combination therapy was found to be generally safe and well-tolerated.
BRII-179 (VBI-2601), an innovative HBV immunotherapy based on recombinant proteins expressing Pre-S1, Pre-S2, and S HBV surface antigens, is designed to stimulate robust B and T cell immune responses. Brii Bio entered into a licensing agreement with VBI Vaccines Inc. in December 2018 for the commercialization rights of BRII-179 in Greater China, which was expanded globally in July of the previous year. The drug was granted breakthrough therapy designation (BTD) status in China in November.
BRII-835 (elebsiran), a small interfering ribonucleic acid (siRNA) administered subcutaneously targeting HBV, was licensed from Vir Biotechnology, Inc. (Nasdaq: VIR) in 2022.- Flcube.com
