#USA #Durham #Brii Bio #BRII-179 #ENSURE Study

Brii Bio's ENSURE Study: Revolutionary Insights into HBsAg Clearance

Brii Biosciences Limited recently presented groundbreaking data from its ongoing Phase 2 ENSURE study at the EASL Congress 2025 in Amsterdam, showcasing the promising role of BRII-179, a novel therapeutic vaccine, in advancing HBsAg clearance in chronic hepatitis B virus (HBV) patients. The data underscore the potential of BRII-179 to enhance the efficacy of existing treatments, exciting healthcare professionals and patients alike.

Study Overview

The ENSURE study, a multicenter, open-label Phase 2 trial, focused on evaluating the effectiveness of a combination therapy involving BRII-179 alongside elebsiran and pegylated interferon alpha (PEG-IFNα) in patients with chronic HBV infection. The study aimed to discern the impact of BRII-179 on surface antigen clearance, particularly in patients with varying immune response levels to prior treatments.

Cohorts 1-3 of the study analyzed patients with baseline HBsAg levels ranging from 100 to 3,000 IU/mL. Notably, Cohort 4 enrolled participants who had previously received nine doses of BRII-179 and later received combination treatment involving elebsiran and PEG-IFNα. The differentiating factor was the patients' immune response—participants were categorized into responders or non-responders based on their anti-HBs titers induced by BRII-179 treatment.

Encouraging Results

The preliminary findings from Cohort 4 have been nothing short of exceptional. At the end of treatment (EOT), 61% of anti-HBs responders achieved HBsAg seroclearance compared to a mere 10% of their non-responding counterparts. Among those who experienced seroclearance, an impressive 91% exhibited high anti-HBs titers at EOT. Furthermore, participants previously treated with BRII-179 displayed a significantly quicker HBsAg clearance rate than naïve participants, with an astonishing 83% achieving HBsAg loss by Week 24 versus 55% in the control group.

These results suggest not only the potential of BRII-179 to optimize treatment outcomes but also provide insight into a novel strategy for patient selection—using prior BRII-179 treatment to identify and prioritize those likely to achieve better functional cure outcomes. The implications of identifying patients with less compromised intrinsic immunity could lead to more personalized and effective treatment pathways.

Complementary Findings

Additional data from earlier cohorts revealed that combination therapy significantly outperformed single-agent PEG-IFNα in terms of sustained HBsAg loss rates post-EOT. The improved outcomes observed in patients receiving elebsiran demonstrated the additive benefits of integrating siRNA technology in chronic HBV management. Fallaciously avoiding additional combinations would not only limit the therapeutic potential but could also prolong the patient’s journey toward recovery.

Dr. David Margolis, Chief Medical Officer of Brii Bio, expressed optimism regarding these findings: "Data from Cohort 4 has provided us with a compelling validation of our approach. Patients displaying immune responses through pre-treatment with BRII-179 showcased incredible benefits in achieving higher rates of HBsAg seroclearance. This reinforces the idea that BRII-179 can help us pinpoint those patients who may respond favorably to future therapies, potentially paving the way for shorter treatment durations and enhanced durable remission rates."

Future Directions

Brii Bio continues to drive forward with rigorous clinical efforts in the quest to find a functional cure for HBV, a condition that affects over 254 million people globally and is a leading cause of liver disease. The introduction of new combination studies and unique therapeutic candidates, such as BRII-179 and elebsiran, highlights the firm’s commitment to providing patients with innovative therapies that address their unmet medical needs. Key data is expected to be presented at various scientific conferences throughout 2025, promising to unveil further advancements in the ongoing battle against this formidable virus.

In conclusion, Brii Bio's Phase 2 ENSURE study showcases how targeted treatment regimens can lead to better health outcomes for those battling chronic HBV infection. The strategy of employing BRII-179 as a means to cultivate an optimal immune response not only represents a significant advancement in treatment protocols but also offers renewed hope for patients worldwide who are eagerly awaiting effective solutions.