#USA #Durham, NC #BRII-179 #Brii Biosciences #elebsiran

Exciting Developments in Hepatitis B Treatment

Brii Biosciences Limited, also known as Brii Bio, has recently announced noteworthy findings from its Phase 2 ENSURE study, published in the esteemed journal Nature Medicine. This signifies a major step forward in the ongoing battle against chronic hepatitis B virus (HBV) infections, which pose a substantial public health threat, affecting over 254 million individuals worldwide.

Overview of the ENSURE Study

The ENSURE study assesses the effectiveness and safety of elebsiran, a small interfering RNA (siRNA) agent, administered alongside pegylated interferon alfa (PEG-IFNα). This dual therapy approach aims to enhance the body's immune response and tackle HBV more effectively compared to the standard PEG-IFNα monotherapy. Furthermore, the study explores the potential of the HBV therapeutic vaccine BRII-179, which has shown promise in enhancing immune responses in patients.

Conducted in two phases, the study initially involved participants who were naive to BRII-179, comparing those treated with a combination of elebsiran and PEG-IFNα against those receiving monotherapy. The second part garnered interest by focusing on patients who had previously reacted to BRII-179, essentially tailoring treatment plans to optimize outcomes based on prior responses.

Key Findings

The results yielded compelling data:

• - HBsAg Loss in Cohorts 1-3: Of 19 participants in Cohort 2 treated with elebsiran (200 mg + PEG-IFNα), 4 (21.1%) achieved HBsAg loss. Meanwhile, 6 out of 18 (33.3%) in Cohort 3 (elebsiran 100 mg + PEG-IFNα) experienced similar success. In stark contrast, only 1 of 18 participants (5.6%) in the PEG-IFNα monotherapy group recorded HBsAg loss, highlighting the superior efficacy of the dual therapy.

• - Cohort 4: In participants previously treated with BRII-179, the results were even more impressive, with 9 out of 31 (29.0%) achieving HBsAg loss. The efficacy was notably higher among BRII-179 anti-HBs responders (42.1%) compared to non-responders (8.3%). This bolsters the notion that BRII-179 primes the immune system, enhancing responses to subsequent therapies.

Overall, the combination therapy of elebsiran and PEG-IFNα exhibited a commendable safety profile, being generally well-tolerated across all study cohorts. This provides critical validation for future studies aiming at a functional cure for HBV.

The Road Ahead

Professor Jidong Jia, the principal investigator of the ENSURE study, expressed optimism regarding the study's outcomes, highlighting the anticipated iterative validation in upcoming confirmatory trials. He anticipates that these findings will refine therapeutic strategies and lead to more personalized patient care in the management of chronic HBV infections.

The innovative protocols employed in this research not only aim to improve patient responses but also seek to minimize unnecessary treatments for those less likely to benefit. Such patient-centric approaches are essential in modern medicine's evolving landscape.

Broader Context on Hepatitis B

Chronic HBV infections remain a leading cause of liver disease globally, with a staggering 820,000 deaths attributed annually due to complications from the disease. The especially high infection rates in regions like China necessitate significant advancements in treatment pathways. With over 87 million chronically infected individuals in China, Brii Biosciences' initiatives could not come at a more crucial time.

Conclusion

Brii Biosciences stands at the forefront of the fight against hepatitis B with its groundbreaking therapies, propelling research towards enhancing patient outcomes in an area historically fraught with substantial medical need. The company continues to pioneer innovations, such as BRII-179, an immunotherapeutic candidate showing promise in amplifying both B-cell and T-cell immunity against HBV.

For more detailed information on the study and its implications, visit Brii Biosciences’ website.