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The low-dose group in the ongoing Phase 1b/2a study assessed patients with chronic hepatitis B infection who were being treated with nucleoside analogs (NUCs) by giving BRII-179 (VBI-2601) joint/non-combined adsulators to reduce HBV DNA in patients with chronic HBV infection compared to subjects treated only with NUC.
The purpose of this early study was to trigger an immune response known to be associated with functional immunity against HBV infection, including stimulating T-cell immunity and inducing the response of HBV surface antigen (S, Pre-S1, Pre-S2) antibodies.
interim data showed that in the study group of low-dose BRII-179 (VBI-2601) combined/non-joint adulations, 67% (n-6/9) and 78% (n-7/9) of assessable patient T-cells had an effect on the re-stimulation of HBV surface antigens.
60% of non-combined adulents in assessable patients (n-6/10) and 67% of co-adulents evaluated patients (n-6/9) observed HBV surface antigen antibody reactions.
low-dose group combined/non-combined adulation immunotherapy were well toned and did not indicate any safety issues.
phase 1b/2a clinical study of BRII-179 (VBI-2601) was a randomized controlled study designed to assess the safety, toerability and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection.
study was designed as a two-part dose incremental study to evaluate low-dose and high-dose BRII-179 (VBI-2601), combined or non-combined adulents, and included a total of 46 patients.
HBV patients who were included in the low-dose group in this study, including e-antigen-positive and e-antigen-negative patients, had an average circulatory level of about 3 log of surface antigen baselines.
the clinical study was conducted by Tensenberg Pharmaceuticals, which plans to conduct clinical studies of more combinations of BRII-179 (VBI-2601) in Asia Pacific and Greater China based on the results of this study.