Brii Biosciences Announces Publication of Phase 2 ENSURE Study Results in Nature Medicine

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].