Brii Biosciences Limited, a biotechnology company developing therapies for diseases with high unmet need, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designations for BRII-877 (tobevibart) and BRII-835 (elebsiran). These investigational therapies target the hepatitis B virus (HBV) and are part of Brii Bio’s efforts towards achieving a functional cure for HBV.

Breakthrough Therapy Designations and Clinical Evidence

BRII-877 (tobevibart)

The Breakthrough Therapy Designation for BRII-877 (tobevibart) was based on Phase 1 and 2 studies conducted by Vir Biotechnology and Brii Bio. As of September 2023, more than 350 people living with HBV have been treated with BRII-877 (tobevibart). The data indicated that BRII-877 is well-tolerated and has resulted in significant reductions in HBsAg levels, suggesting its potential as a crucial component of a treatment regimen for chronic HBV and chronic hepatitis D virus (HDV) infections.

BRII-835 (elebsiran)

The designation for BRII-835 (elebsiran) was supported by Phase 1 and 2 studies involving over 570 participants. These studies showed that BRII-835 is well-tolerated and demonstrated direct antiviral activity against HBV in participants with chronic HBV and HDV infections.

Advancing Towards a Functional Cure

Dr. Qing Zhu, Head of China R&D at Brii Bio, stated, “Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835, along with the earlier designation for BRII-179, supports our scientific rationales in developing functional cure combination regimens for chronic HBV infection.” This progress positions Brii Bio uniquely to address broader HBV infection populations, including co-infection with HDV.

Future Clinical Trials and Registration Strategy

Brii Bio, in collaboration with Vir Biotechnology, plans to initiate multiple combination studies in 2024. These studies aim to optimize curative regimens, informing the company’s registration strategy to bring effective treatments to HBV patients.

Financial and Operational Context

While the financial details of the designations are not specified, the strategic importance lies in the potential impact on the HBV treatment landscape. The designations mark significant milestones in Brii Bio’s pursuit of a functional cure for HBV, building on the company’s comprehensive clinical data and insights gained over the past five years.

Regulatory and Compliance Information

Investors and stakeholders are encouraged to follow updates from Brii Bio and Vir Biotechnology as they progress towards late-stage development plans for HBV therapies.

Brii Biosciences Limited’s recent Breakthrough Therapy Designations for BRII-877 and BRII-835 underscore the company’s commitment to advancing HBV treatment options. With comprehensive clinical data and strategic collaborations, Brii Bio is well-positioned to make significant strides towards a functional cure for HBV, addressing both HBV and HDV infections in broader patient populations.

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