BRII-B (02137): Publish the results of the ENSURE II study in "Nature Medicine."

BRII-B (02137) has released an announcement that the results of the ENSURE II study have been published in the peer-reviewed journal "Nature Medicine." The study evaluated the effectiveness and safety of the siRNA drug elebsiran in combination with pegylated interferon alpha (PEG-IFN) treatment regimen, with PEG-IFN monotherapy as the control group. Additionally, the study also explored the potential role of the therapeutic vaccine BRII-179 for hepatitis B virus (HBV) in identifying immunoreactive patients and increasing the clearance rate of hepatitis B surface antigen (HBsAg). The article, titled "Elebsiran and PEG-IFN treatment in chronic hepatitis B infection: a partial randomized, open-label phase II clinical trial," is now available online. The ENSURE study was conducted in two parts among chronic HBV patients with viral suppression. In the first part (cohorts 1-3), participants who had not received BRII-179 were randomly assigned to receive 48 weeks of PEG-IFN monotherapy or combination treatment with elebsiran (administered every 4 weeks at a dose of 200mg or 100mg). In the second part (cohort 4), participants who had previously completed the Phase II study (BRII-179-835-001) and received 9 doses of elebsiran in combination with BRII-179, were categorized as BRII-179 anti-HBs responders or non-responders based on hepatitis B surface antibody ("anti-HBs") titers peak levels (10 IU/L or <10 IU/L), and then received 48 weeks of elebsiran (100mg Q4W) in combination with weekly PEG-IFN treatment in the ENSURE study. Professor Ji Dong Jia, the lead investigator of the ENSURE study, stated, "The ENSURE study aims to provide much-needed scientific evidence for curative therapy for chronic hepatitis B and answer some key scientific questions. Encouragingly, the 24-week follow-up data are consistent with the results at the end of treatment, providing further support for additional clinical benefits of elebsiran, while also suggesting a potential new role for BRII-179 in activating the immune system of chronic hepatitis B patients and enriching this population to achieve higher rates of functional cure. We look forward to further confirming these findings in confirmatory studies."