Study in Chronic Hepatitis B Patients.
VBI Vaccines Inc., a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the first patient has been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179), an immunotherapeutic candidate targeting chronic hepatitis B virus (HBV).
This newly announced Phase 2 study will assess VBI-2601 as an add-on therapy to the standard-of-care, nucleos(t)ide reverse transcriptase inhibitor (Nrtl) and pegylated interferon (PEG-IFN-α) therapy, which currently has a functional cure rate of approximately 9%. A functional cure for chronic HBV infection is defined as achievement of undetectable HBV surface antigen (HBsAg) levels and sustained suppression of HBV DNA.
VBI-2601 is also being assessed in an additional Phase 2 study as part of a combination regimen with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting HBV.
“Our commitment to the fight against hepatitis B includes a focus on both prevention and treatment of the disease,” said Jeff Baxter, VBI’s President and CEO. “More than 290 million people are chronically infected with HBV worldwide and, together with our partners, we are working hard to provide more patients with improved therapeutic options.
This effort includes the assessment of new investigational treatment regimens, as in the ongoing combination study of VBI-2601 and an siRNA candidate, as well as ways to potentially improve upon functional cure rates achieved with the current standard of care, as with this newly announced Phase 2 study. We believe a multi-pronged approach is critical for driving innovation in the treatment of chronic HBV, and we look forward to sharing data from these two Phase 2 studies in the second half of 2022 and the first half of 2023, respectively.”
The Phase 2a/2b trial of VBI-2601 (BRII-179) is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding VBI-2601 (BRII-179) to existing PEG-IFN-α and Nrtl standard-of-care therapy in non-cirrhotic chronic HBV patients. Patients participating in the study have had partial responses to ongoing PEG-IFN-α and NrtI treatment.
- Expected enrollment of 120 patients
- Primary endpoint: The percentage of patients with HBsAg loss at completion of treatment
- Expanded enrollment of 480 patients
- Primary endpoint: The percentage of patients achieving a functional cure, defined as undetectable HBsAg and sustained suppression of HBV DNA
An independent Data and Safety Monitoring Board will monitor patient safety and efficacy data for this study.