Brii Biosciences Announces Two Breakthrough Therapy Designations for BRII-877 and BRII-835 Building on Extensive Clinical Evidence from Multiple Phase 2 Studies
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.
- Breakthrough Therapy Designations for BRII-877 and BRII-835 by NMPA.
- Extensive clinical evidence supporting both therapies from Phase 1 and 2 studies.
- BRII-877 has shown marked decreases in HBsAg levels in over 350 patients.
- BRII-835 demonstrated robust antiviral activity in over 570 patients.
- Both therapies were well-tolerated in clinical trials.
- Enhanced potential for developing functional cure regimens for chronic HBV and HDV infections.
- Strong collaboration with Vir Biotechnology, adding to comprehensive clinical data.
- No specific timelines mentioned for the completion of late-stage development plans.
- Breakthrough Therapy Designations indicate potential but not guaranteed market approval.
- High reliance on future combination studies to optimize therapeutic regimens.
- Potentially high costs and resource requirements for ongoing and future clinical trials.
Insights
The granting of Breakthrough Therapy Designations (BTD) for BRII-877 and BRII-835 signifies major progress for Brii Biosciences. These designations indicate that the therapies may offer substantial improvement over existing treatments for chronic HBV infection, a disease with significant unmet medical need. The evidence from Phase 1 and 2 studies, showing that both therapies are well-tolerated and effective in reducing viral markers, is promising. This could potentially accelerate the time to market for these treatments, benefiting patients sooner.
From a broader perspective, achieving BTD for multiple therapies in HBV places Brii in a strong position in the competitive HBV market. This aligns well with the company's strategy to develop a functional cure for HBV, leveraging various therapeutic modalities. The combination approaches mentioned further suggest a comprehensive and innovative strategy aimed at maximizing patient outcomes.
Brii Biosciences' receipt of Breakthrough Therapy Designations for two of its HBV-related therapies is likely to have a favorable impact on its stock price. BTDs generally lead to expedited development and review processes, potentially bringing these therapies to market faster and providing a significant competitive advantage. The positive clinical trial outcomes underscore the credibility of Brii's R&D capabilities and could attract further investments.
Investors should note that these designations could lead to increased shareholder value due to the potential for higher revenue streams from new, effective treatments. However, there are inherent risks, including the possibility of unforeseen challenges in later-stage trials and regulatory hurdles. Therefore, while the news is positive, investors should remain cautious and consider the long-term horizon.
The biotechnology sector, particularly in the area of HBV treatment, is highly competitive. The recent Breakthrough Therapy Designations for BRII-877 and BRII-835 position Brii Biosciences favorably within this landscape. These designations not only validate the therapeutic potential of Brii's pipeline but also enhance its strategic position compared to competitors.
The intended combination studies slated for 2024 could further strengthen Brii's market position by optimizing treatment regimens, thereby addressing a broader segment of the HBV patient population. Market analysts should monitor the company's progress closely, particularly the outcomes of these combination studies, as they will be critical for assessing the long-term market potential and economic viability of these therapies.
DURHAM, N.C. and BEIJING, May 13, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designations for BRII-877 (tobevibart), an investigational broadly neutralizing monoclonal antibody targeting hepatitis B virus (HBV) and BRII-835 (elebsiran), an investigational HBV-targeting small interfering ribonucleic acid (siRNA). This represents another milestone in the Company's pursuit of a functional cure for HBV, following the Breakthrough Therapy Designation granted for BRII-179, a recombinant protein-based HBV immunotherapeutic, in November 2023.
The Breakthrough Therapy Designation for BRII-877 (tobevibart) was supported by Phase 1 and 2 studies conducted by Vir Biotechnology ("Vir", Nasdaq: VIR) and Brii Bio. As of September 2023, more than 350 people living with HBV have received treatment of BRII-877 (tobevibart). Data has shown BRII-877 (tobevibart) to be well-tolerated and to have resulted in marked decreases in HBsAg levels suggesting the potential for BRII-877 (tobevibart) to be an important part of a treatment regimen for people living with chronic HBV infection and chronic hepatitis D virus (HDV) infection. The Breakthrough Therapy Designation for BRII-835 (elebsiran) was supported by Phase 1 and 2 studies conducted by Brii Bio and its partner Vir. As of September 2023, more than 570 people living with HBV have participated in clinical studies where BRII-835 (elebsiran) has been shown to be well-tolerated and has demonstrated direct antiviral activity against HBV in participants with chronic HBV and HDV infection.
"Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835 as well as the earlier Breakthrough Therapy Designation for BRII-179 further supports our long-held scientific rationales in the development of functional cure combination regimens for patients with chronic HBV infection," said Dr. Qing Zhu, Head of China R&D, Brii Bio. "Brii Bio and our partner Vir Biotechnology have conducted numerous clinical trials over the past five years, from which we have gained comprehensive clinical safety and efficacy data as well as critical insight towards our late-stage development plan and achieving potentially higher rates of HBV functional cure in broader patient populations."
Having three breakthrough therapeutic modalities puts the Company in a unique position to address the broader populations of HBV infections including co-infection with HDV. As part of Brii Bio's approach to developing a functional cure for HBV, the Company and its partner Vir are progressing plans to initiate multiple combination studies in 2024 to further optimize the curative regimens that will inform the Company's registration strategy to bring the best regimens to HBV patients.
About Hepatitis B
Hepatitis B viral infection (HBV) 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 each year.1 HBV is of exceptional concern in
About Hepatitis D
Hepatitis D is a liver inflammation caused by the hepatitis D virus (HDV), which relies on hepatitis B virus (HBV) for replication. This infection can only occur in the presence of HBV. The combination of HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis, leading to a quicker progression towards hepatocellular carcinoma and liver-related death. Globally, nearly
About BRII-877 (Tobevibart)
BRII-877 (tobevibart) is an investigational subcutaneously administered neutralizing monoclonal antibody designed to block entry of HBV and HDV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (tobevibart), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV and HDV, as well as to have an extended half-life. Brii Bio licensed exclusive rights to develop and commercialize BRII-877 (tobevibart) for the greater
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
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 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 viral infection (HBV). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the
[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/publications/i/item/9789240091672
[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%
[3] World Health Organization. (July 2023). Hepatitis D. World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-d
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