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Brii Biosciences Limited presented a cross-study analysis of post-treatment hepatitis B surface antigen (HBsAg) rebound profiles at the 35th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2026), held April 22-25, 2026 in Istanbul, Turkey.
The analysis focused on post-end-of-treatment (EOT) HBsAg rebound in NRTI-experienced participants with chronic hepatitis B virus (HBV) infection who achieved HBsAg loss in two Phase 2 studies: ENSURE and BRII-179-002. Data from both studies were pooled to evaluate the incidence, magnitude, and clinical relevance of HBsAg rebound following EOT in participants treated with peginterferon alfa (PEG-IFNα) alone or in combination with elebsiran or BRII-179.
The Phase 2 ENSURE study is designed to assess safety and efficacy of combination approaches aimed at improving functional cure outcomes. Cohorts 1-3 evaluate elebsiran in combination with PEG-IFNα versus PEG-IFNα monotherapy, while Cohort 4 evaluates BRII-179 to identify immunologically responsive patients and improve HBsAg loss rates.
The Phase 2 BRII-179-002 study is a multicenter, randomized, double-blind, proof-of-concept trial evaluating BRII-179 as an add-on therapy to PEG-IFNα.
Across the pooled datasets, the company reported favorable off-treatment clinical outcomes, with HBsAg rebounds remaining below 100 IU/mL and most rebounds below 10 IU/mL. HBV DNA rebound was described as infrequent and not associated with clinically meaningful alanine aminotransferase (ALT) elevations following NRTI discontinuation.
In the oral presentation, Brii reported that post-EOT HBsAg rebound occurred in 24 of 55 participants (43.6%). The rebound rates were similar during NRTI consolidation and after NRTI discontinuation, at 13/55 (23.6%) and 11/41 (26.8%), respectively.
The company also reported that shorter NRTI consolidation periods were not associated with higher HBsAg rebound rates after NRTI withdrawal. Specifically, 15.0% (3/20) of participants receiving 12-20 weeks of NRTI consolidation and 23.8% (5/21) of those receiving 24 weeks experienced HBsAg rebound by 24 weeks after NRTI discontinuation.
Regarding rebound magnitude, all rebounds were reported as less than 100 IU/mL, and 75.0% (18/24) remained below 10 IU/mL. HBV DNA rebound after NRTI discontinuation was described as infrequent, with more than 90% (38/41) of participants maintaining HBV DNA.
Brii said the results support durable post-treatment immunological control and further support the potential for safe discontinuation of NRTIs in PEG-IFNα-based combinations with novel therapeutic modalities. The company highlighted that shorter NRTI consolidation periods (12 to 20 weeks versus 24 weeks) were not associated with higher HBsAg rebound rates, suggesting shortening—and potentially eliminating—the consolidation period may be feasible in future treatment strategies.
“We are encouraged by the growing evidence showing that our novel therapeutic combinations can achieve not only rapid HBsAg loss, but also durable immunological control after treatment withdrawal,” said David Margolis, M.D., Chief Medical Officer of Brii Bio. “These findings strengthen our confidence in the potential of BRII-179 and elebsiran as components of next-generation HBV cure strategies, and we look forward to additional readouts from our ongoing studies throughout 2026.”
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