VBI Vaccines and Brii Biosciences have initiated a Phase Ib/IIa clinical trial to test BRII-179 (VBI-2601) for the treatment of patients with chronic hepatitis B virus (HBV) infection.

BRII-179 is a recombinant, protein-based immunotherapeutic that acts on B-cell and T-cell immunity via various mechanisms of action.

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The drug candidate neutralises the circulating hepatitis B virus, blocks the infection of hepatocytes through Pre-S1, and allows immune-mediated clearance of virus-infected hepatocytes.

It is intended to restore immunologic control by targeting the extracellular steps in the virus lifecycle.

HBV affects nearly 290 million people worldwide and can cause liver disease and liver cancers. Around 780,000 patients are estimated to die each year from HBV-related complications, including liver decompensation and hepatocellular carcinoma.

VBI Vaccines president and CEO Jeff Baxter said: “Chronic HBV has long been considered one of the most challenging viral infections to treat, due to its complex lifecycle once it takes hold in the liver.

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“There is growing consensus in the scientific community that a functional cure for HBV is possible and that it will require restoration of HBV immunity to ensure the body’s own ability to control the viral infection.

“We believe BRII-179 (VBI-2601) has the potential to be a critical and differentiated component of a functional cure for HBV.”

Sponsored by Brii Bio, the randomised, controlled, two-part, dose-escalation Phase Ib/IIa trial will evaluate the safety, tolerability and antiviral activity of different doses of the drug candidate in HBV-infected individuals.

The trial will enrol up to 65 patients at sites in Australia, New Zealand, China, Thailand, South Korea and Hong Kong. The first study participant has been dosed.

Initial proof-of-concept results from the study are set to be reported in the second half of next year.