#BRII-179 #Brii Biosciences #ENSURE Study

Brii Biosciences Presents Encouraging Findings from the Phase 2 ENSURE Study

Brii Biosciences Limited has made headlines at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China, with the presentation of new data from its ongoing Phase 2 ENSURE study. This groundbreaking research highlights the potential of BRII-179, a novel recombinant protein-based therapeutic vaccine, in identifying chronic hepatitis B virus (HBV) patients more likely to respond to treatment and achieve higher rates of hepatitis B surface antigen (HBsAg) clearance.

The ENSURE study (NCT05970289) is a multicenter, open-label trial assessing BRII-179 in conjunction with elebsiran, an investigational small interfering RNA (siRNA), and pegylated interferon alpha (PEG-IFNα). The findings from the initial three cohorts demonstrated the added benefits of combining elebsiran with PEG-IFNα for patients presenting with elevated HBsAg levels between 100-3,000 IU/mL.

In Cohort 4, data revealed that participants who previously exhibited an anti-HBs response following BRII-179 treatment showed significantly higher rates of HBsAg seroclearance—approximately 55.6% of those who responded to BRII-179 compared to just 10% of non-responders. These results suggest that BRII-179 could be a valuable predictive tool in refining patient selection for curative therapies.

Dr. Grace Lai-Hung Wong, a prominent gastroenterology expert at the Chinese University of Hong Kong, noted, “The positive outcomes from Cohort 4 have opened new avenues for achieving a functional cure for HBV. The evidence supports BRII-179's role in identifying chronic hepatitis B patients capable of eliciting the required HBsAg antibody response.