Core Insights - The article discusses the results of Brii Biosciences' Phase 2 ENSURE study, which evaluates the efficacy and safety of the siRNA elebsiran in combination with pegylated interferon alfa (PEG-IFN) for chronic hepatitis B infection, alongside the potential role of the HBV therapeutic vaccine BRII-179 [1][3][4]. Study Design and Results - The ENSURE study was conducted in two parts with virally suppressed chronic HBV patients, comparing PEG-IFN monotherapy to a combination of PEG-IFN and elebsiran [3]. - In Cohorts 1-3, HBsAg loss was observed in 21.1% of participants receiving elebsiran 200 mg + PEG-IFN and 33.3% in those receiving elebsiran 100 mg + PEG-IFN, compared to 5.6% in the PEG-IFN monotherapy group [9]. - In Cohort 4, 29.0% of participants achieved HBsAg loss, with a higher response rate of 42.1% among BRII-179 anti-HBs responders compared to 8.3% in non-responders [9]. Therapeutic Implications - The study's design provides a benchmark for future siRNA development towards achieving an HBV functional cure, highlighting the clinical benefit of elebsiran over monotherapy [4]. - The findings suggest that BRII-179 may enhance immune system responsiveness, leading to improved outcomes in patients with high baseline HBsAg levels [6]. Safety Profile - The combination therapy of elebsiran and PEG-IFN was reported to be generally safe and well tolerated across all cohorts [9]. Company Background - Brii Biosciences is focused on developing therapies for infectious diseases, particularly hepatitis B, and has a pipeline that includes innovative candidates like elebsiran and BRII-179 [13].

Core Insights - Brii Biosciences Limited is advancing its hepatitis B virus (HBV) functional cure program through multiple Phase 2b trials, including ENRICH and ENHANCE studies, aiming for higher cure rates [2][5] - The company has entered a strategic collaboration with Joincare Pharmaceutical Group for the development of soralimixin in Greater China, enhancing its portfolio and partnership strategy [2][8] - Brii Bio maintains a strong cash position of US$289.9 million, sufficient to support its late-stage development plans and early discovery initiatives [3][13] HBV Program Updates - The ENSURE study shows that prior treatment with BRII-179 and elebsiran can induce robust anti-HBs responses, with 61% of patients achieving HBsAg seroclearance at Week 48 [6] - The company is assessing BRII-179 in two additional Phase 2b trials, ENRICH and ENHANCE, to identify optimal combination regimens for HBV treatment [12] - Data from the ongoing studies are expected to inform the next phase of the clinical strategy for HBV functional cure [9][12] Financial Performance - As of June 30, 2025, the company's cash and cash equivalents were RMB2,075.3 million, a decrease of 14.0% from the previous year, primarily due to R&D expenditures [13] - Research and development expenses for the first half of 2025 were RMB117.0 million, reflecting a decrease of 7.3% compared to the same period in 2024, indicating effective cost control measures [13][20] - Administrative expenses decreased by 26.0% to RMB58.2 million, attributed to reduced employee costs and facility-related expenses [20] Strategic Outlook - Brii Bio is committed to delivering innovative therapies for infectious diseases, with a focus on achieving a functional cure for HBV [9] - The company plans to continue expanding its internal discovery capabilities and partnerships to drive sustainable growth [4][10] - Key data readouts from the HBV functional cure program are expected in the first half of 2026, which will shape future clinical strategies [9]

Core 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]