Target(US:TGT) Prnewswire·2025-03-30 11:10Core Insights - Brii Biosciences Limited announced new data from its Phase 2 ENSURE study at the APASL 2025 meeting, highlighting the potential of its therapies for chronic HBV infection [1][5] Study Design and Objectives - The ENSURE study is a multicenter, open-label Phase 2 trial designed to evaluate the efficacy of elebsiran in combination with pegylated interferon alpha (PEG-IFNα) in chronic HBV patients [2] - Cohort 4 included participants who previously received BRII-179, a therapeutic vaccine, to assess the combination treatment's effectiveness [2] Key Findings - In Cohort 4, 55.6% of BRII-179 responders achieved HBsAg seroclearance at Week 24, compared to only 10% in non-responders, indicating BRII-179's potential as a predictive tool for treatment response [3][10] - Data from Cohorts 1-3 showed higher rates of HBsAg loss and seroconversion in participants receiving elebsiran with PEG-IFNα compared to those receiving PEG-IFNα alone [4][11] Expert Commentary - Dr. Grace Lai-Hung Wong emphasized that the positive results from Cohort 4 support the potential of BRII-179 in identifying patients likely to respond to curative therapies [5] - David Margolis, MD, noted that the findings reinforce the strategy of using BRII-179 to enhance functional cure rates while minimizing unnecessary treatment costs for less responsive patients [5] Broader Context - Chronic HBV infection affects over 254 million people globally, with significant mortality rates, particularly in regions like China where 87 million are chronically infected [9] - BRII-179 is a novel immunotherapeutic candidate designed to enhance immune responses against HBV, and it has received Breakthrough Therapy Designation from the CDE in China [9][10] Future Directions - Brii Bio is advancing multiple combination studies involving BRII-179 and elebsiran, with key data expected to be presented at scientific conferences throughout 2025 [8][10]