BRII-B (02137) announced that the results of its ENSURE Phase II study have been published in the peer-reviewed journal Nature Medicine. The study evaluated the efficacy and safety of siRNA drug elebsiran combined with pegylated interferon alpha (PEG-IFNα) therapy, with PEG-IFNα monotherapy serving as the control group. Additionally, the research explored the potential role of the hepatitis B virus (HBV) therapeutic vaccine BRII-179 in identifying immune-responsive patients and improving hepatitis B surface antigen (HBsAg) clearance rates. The article, titled "Elebsiran and PEG-IFNα for Chronic Hepatitis B Infection: A Partially Randomized, Open-Label Phase II Clinical Trial," is now available online.
The ENSURE study was conducted in two parts among virally suppressed chronic HBV patients. In the first part (Cohorts 1-3), participants who had not received BRII-179 were randomized to receive either 48 weeks of PEG-IFNα monotherapy or combination therapy with elebsiran (administered every four weeks (Q4W) at doses of 200mg or 100mg). In the second part (Cohort 4), participants who had previously received nine doses of elebsiran combined with BRII-179 in an earlier Phase II study (BRII-179-835-001) were categorized as BRII-179 anti-HBs responders or non-responders based on peak anti-HBs titer levels (≥10 IU/L or <10 IU/L, respectively). These participants then received 48 weeks of elebsiran (100mg Q4W) combined with weekly PEG-IFNα therapy in the ENSURE study.
Professor Jia Jidong, the lead principal investigator of the ENSURE study, stated, "The ENSURE study aims to provide much-needed scientific evidence for curative therapies for chronic hepatitis B and address some key scientific questions. Encouragingly, the 24-week follow-up data align with the trends observed at the end of treatment, offering further support for the additional clinical benefits of elebsiran while suggesting a potential new role for BRII-179 in activating the immune response of chronic HBV patients and enriching this population to achieve higher functional cure rates. We look forward to further validating these findings in confirmatory studies."