DURHAM -
We reported in previous studies that BRII-179 induced broad antibody and T-cell responses against Pre-S1, Pre-S2 and S epitopes in CHB patients.
The cohort level unblinded data from the study demonstrated that in the intent to treat analysis at Week 24 (end of treatment or EoT), 26.3% (15 patients) treated with BRII-179/PEG-IFN achieved HBsAg loss compared to 19.3% (11 patients) with placebo/PEG-IFN; at Week 36 (12 weeks follow-up), 24.6% (14 patients) treated with BRII-179/PEG-IFN had HBsAg loss, compared with 14.0% (8 patients) with placebo/PEG-IFN. In the per protocol analysis at Week 24, 32.6% (15 patients) treated with BRII-179/PEG-IFN achieved HBsAg loss compared to 21.6% (11 patients) with placebo/PEG-IFN; at Week 36, 31.8% (14 patients) and 14.9% (7 patients) had HBsAg loss, respectively. In addition, 9 out of 15 patients in the cohort treated with BRII-179/PEG-IFN achieved HBsAg seroconversion at EoT (Week 24), versus 1 out of 11 in the cohort treated with PEG-IFN alone. The cohort level unblinded 24 weeks safety data showed BRII-179/PEG-IFN treatment was generally safe and tolerated, with adverse events similar to those associated with PEG-IFN treatment or BRII-179 as previously reported. Follow up is ongoing.
'We are excited by the data from this proof-of-concept study consistent with our previous proof-of-mechanism studies that BRII-179 induces functional immune responses complementing other curative treatment modalities such as PEG-IFN,' said
Promising results from multiple studies, including
Meanwhile, Brii Bio's newly launched Phase 2 HBV study evaluating BRII-835 + PEG-IFN versus PEG-IFN active control arm, aims to clarify the additional functional cure efficacy of the combination. The Company intends to include patients in the APAC region who were previously exposed to BRII-179 in the Phase 2 study. The Company believes that BRII-179 has the unique ability to distinguish patients who have significant intrinsic humoral immunity versus those who do not.
In
About BRII-179 (VBI-2601) + PEG-IFN Combination Study
The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled, parallel study designed to evaluate the safety and efficacy of BRII-179 as an add-on therapy to PEG-IFN and NrtI therapy for the treatment of chronic HBV infection. This study enrolled adult HBV patients in mainland
About Hepatitis B
Hepatitis B viral infection is one of the world's most significant infectious disease threats with more than 290 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in
About BRII-179 (VBI-2601)
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 and broad B-cell and T-cell immunity. BRII-179 is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 (VIR-2218) and PEG-IFN as part of a potential functional cure regimen for the treatment of chronic HBV infection.
About Brii Bio
Contact:
Email: media@briibio.com
(C) 2023 Electronic News Publishing, source