Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials

2024-06-07

交易

临床结果临床2期疫苗引进/卖出

DURHAM, N.C. and BEIJING, June 7, 2024. Brii Biosciences Limited ("Brii Bio," "we," or the "Company"), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on therapy to pegylated interferon-alpha (PEG-IFNα) treatment for chronic hepatitis B virus (HBV) infection at the EASL™ (European Association for the Study of the Liver) Congress 2024.

Data presented in an oral presentation from a Phase 2 clinical trial demonstrated BRII-179, a therapeutic vaccine, in combination with BRII-835 (elebsiran) induced substantial HBV-specific B and T cell responses that correlate with antiviral effect in a subset of participants with chronic HBV infection. The exploratory translational study evaluating the correlation of treatment-induced immune response with antiviral effects demonstrated:

"This study shows for the first time direct evidence that immune responses induced by an HBV therapeutic vaccine is associated with HBsAg reduction and viral control in some participants with chronic HBV infection," said Antonio Bertoletti, MD, Professor, Emerging Infectious Diseases Program at Duke-NUS Medical School. "The antiviral activity appears to be linked with a boosting of anti-HBs antibodies and Pre-S1-specific T cell responses induced by BRII-179, supporting that BRII-179 can break immune tolerance and have an impact on sustained control of the viral infection."

Additionally, late-breaker poster presentation data from a Phase 2 clinical trial demonstrated that BRII-179, administrated on top of PEG-IFNα, improved overall HBsAg loss rate from end-of-treatment (EOT) to at least 24 weeks post nucleos(t)ide reverse transcriptase inhibitors (NRTI) discontinuation compared to the PEG-IFNα group. Follow-up data from this randomized, double-blind, placebo-controlled clinical trial in 114 virally-suppressed participants with chronic HBV infection showed:

The favorable benefit-risk profile and scientific insights from these studies support further clinical evaluation of BRII-179 in combination with other modalities such as siRNA and PEG-IFNα as key components for the treatment of chronic HBV infection, with the goal of achieving functional cure.

About BRII-179

BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023.

About BRII-835 (Elebsiran)

BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020.

About Hepatitis B

Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2]

About Brii Bio

Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai

References

[1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/publications/i/item/9789240091672

[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/china/health-topics/hepatitis

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