Brii Biosciences Limited, a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, has dosed the first patient in a Phase 2a/2b clinical trial for BRII-179 (VBI-2601) in patients with chronic hepatitis B virus (HBV). An estimated 290 million people worldwide are living with chronic HBV infection, and nearly 800,000 people die each year from complications such as HBV-related cirrhosis, liver failure, and related cancers.
“BRII-179 has the potential to break immune tolerance and restore or augment adaptive T cell and antibody responses to HBV surface antigens. This would establish a durable immune response to HBV and create the possibility of achieving a functional cure for chronic HBV infection,” said Li Yan, MD, Ph.D., chief medical officer at Brii Bio. “Chronic HBV patients currently only have access to treatments that result in a single-digit functional cure rate. We look forward to working with our investigators in China to determine the safety and impact of BRII-179 in reinvigorating HBV-specific adaptive immune function in this patient population, which could potentially translate into a significantly higher functional cure rate.”
BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced B-cell and T-cell immunity. BRII-179 (VBI-2601) builds upon the 3-antigen conformation of VBI Vaccines’ prophylactic HBV vaccine, which is approved in the U.S. under the name PreHevbrio™ [Hepatitis B Vaccine (Recombinant)].
This Phase 2 trial of BRII-179 is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding BRII-179 (VBI-2601) to existing PEG-IFN-α and nucleos(t)ide reverse transcriptase inhibitor (NrtI) standard-of-care therapy in non-cirrhotic chronic HBV patients. Patients participating in the study have met a pre-defined criteria for partial responses to ongoing PEG-IFN-α and NrtI treatment. An independent Data and Safety Monitoring Board will monitor patient safety and treatment efficacy data for this study.
Phase 2a:
• The Phase 2a part of the study will determine the efficacy and safety of BRII-179 (VBI-2601) therapy in approximately 120 patients in combination with PEG-IFN-α + Nrtl therapy.
• The primary endpoint of Phase 2a is the percentage of patients with HBsAg loss at the completion of treatment.
Phase 2b:
• In Phase 2b, the study will expand to 480 patients to evaluate the proportion of patients achieving functional cure after receiving BRII-179 (VBI-2601) therapy in combination with PEG-IFN-α + NrtI.
• The primary endpoint of Phase 2b is the percentage of patients achieving sustained HBsAg and HBV DNA loss.
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