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Brii Bio Announces Topline End-of-Treatment Data from Phase 2b ENRICH and ENHANCE Studies for the Treatment of Chronic Hepatitis B
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Jul 03, 2026
- End-of-treatment data from ENRICH demonstrated higher HBsAg loss rates, consistent with ENSURE Cohort 4, confirming the role of BRII-179 in priming immune responses for functional cure strategies
- End-of-treatment data from ENHANCE did not demonstrate improved HBsAg loss rates compared to ENSURE Cohorts 2 and 3, informing selection of combination regimen going forward
- As previously disclosed, advancement of ENRICH into Phase 3 remains subject to the outcome of arbitration with Vir Biotechnology regarding the elebsiran manufacturing technology transfer
DURHAM, N.C. and BEIJING, China - July 3, 2026 -
The ENRICH and ENHANCE studies are two Phase 2b studies designed to further define the role of BRII-179 in chronic HBV treatment and to select the optimal combination regimen for future development. The ENRICH study evaluates BRII-179 as a priming therapy administered prior to elebsiran and PEG-IFNα treatment. The ENHANCE study evaluates a concurrent triple combination regimen of BRII-179, elebsiran, and PEG-IFNα to enhance the functional cure rates.
At EOT, the ENRICH study evaluating pre-treatment with BRII-179 followed by elebsiran and PEG-IFNα demonstrated hepatitis B surface antigen (HBsAg) loss rates of 42.9% (42/98) and 40.0% (20/50) across two different BRII-179 dosing schedules, being 5 doses administered once every 3 weeks versus 7 doses administered once every 2 weeks, respectively. These results were consistent with the HBsAg loss rate observed in ENSURE Cohort 4, 41.9% (13/31) in patients with prior BRII-179 treatment, supporting the immune priming role of BRII-179. The Company had engaged with the Center for Drug Evaluation of the National Medical Products Administration of China and reached preliminary alignment regarding a potential registrational study.
At EOT, the ENHANCE (Part A-1) study evaluating a concurrent triple combination did not demonstrate improved HBsAg loss rates compared with ENSURE Cohorts 2 and 3, 29.7% (11/37), with an observed rate of 25.5% (25/98). However, higher HBsAg loss rates were observed compared with the PEG-IFNα control arm, 10.2% (5/49).
Subgroup analyses from the ENRICH study suggest potential differentiation in subjects with higher baseline HBsAg levels (1000-3000 IU/mL), consistent with prior findings from ENSURE Cohort 4, indicating that BRII-179 may induce beneficial immune responses regardless of baseline HBsAg levels in this difficult-to-treat population.
The ENHANCE study, Part A-2, also evaluated a sequential approach designed to potentially shorten PEG-IFNα therapy by administering BRII-179 plus elebsiran during the first 24 weeks followed by 24 weeks of elebsiran and PEG-IFNα. At EOT, this combination regimen achieved an HBsAg loss rate of 22.5% (18/80), suggesting full course of PEG-IFNα therapy is needed for optimal curative outcome.
HBsAg loss is an important endpoint when evaluating functional cure regimens, but requires confirmation during off-treatment follow-up to assess rebound and durability of functional cure. No new safety concerns were identified in either study. The Company plans to present detailed data, including additional efficacy, safety, subgroup analyses and follow-up results, at a scientific conference in the second half of 2026.
https://www.briibio.com/en/media/press-release/20260703/
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