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Brii Biosciences Limited (BRIBY) is a biotechnology company focused on developing therapies for diseases with high unmet needs. The company's innovative treatments aim to improve patient health and choice, particularly in infectious and central nervous system diseases. Brii Bio has a broad pipeline of therapeutic candidates targeting conditions like hepatitis B viral infection (HBV), postpartum depression (PPD), and major depressive disorder (MDD). With a leadership team dedicated to addressing public health challenges, Brii Bio operates in key biotech hubs including Raleigh-Durham, the San Francisco Bay Area, Beijing, and Shanghai.
Brii Bio announced new data from its Phase 2 ENSURE study, comparing elebsiran (BRII-835) combined with PEG-IFNα versus PEG-IFNα alone in chronic HBV patients. The 48-week end-of-treatment results showed significantly higher HBsAg seroclearance rates in combination therapy groups: 26.3% (200mg elebsiran) and 33.3% (100mg elebsiran) versus 5.6% with PEG-IFNα alone. In patients with baseline HBsAg of 100-1,500 IU/mL, the combination achieved even higher rates: 31.3% (200mg) and 40.0% (100mg). The combination therapy demonstrated greater HBsAg reductions and was generally safe and well-tolerated.
Brii Bio presented new data from its ongoing Phase 2 trials at the EASL Congress 2024. The data revealed that BRII-179, a therapeutic vaccine, induced significant immune responses and high levels of HBsAg reduction in some participants with chronic HBV infection.
The trials evaluated BRII-179 either in combination with BRII-835 (elebsiran) or as an add-on to PEG-IFNa treatment. Findings included increased B and T cell responses, enhanced HBsAg loss post-treatment, and no need for NRTI retreatment.
The combination therapies were safe and well tolerated, supporting further evaluation for achieving a functional cure for chronic HBV infection.
Brii Biosciences announced that the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designations for two of its investigational therapies: BRII-877 (tobevibart) and BRII-835 (elebsiran). These therapies target hepatitis B virus (HBV) and are supported by extensive Phase 1 and 2 studies. BRII-877 has treated over 350 patients, showing well-tolerated results and significant decreases in HBsAg levels. BRII-835, studied in over 570 patients, demonstrated robust antiviral activity against HBV. These designations bolster Brii Bio’s ongoing efforts to develop functional cures for chronic HBV and HDV infections, enhancing their therapeutic regimens to achieve higher cure rates in broader patient populations.
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