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BRII-179

Phase 2

For Treatment of Chronic Hepatitis B Virus Infection | Monoclonal antibody | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Dec 30, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

BRII-179 · 1 trial · 1 indication

Phase 2 1
NCT06491563Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)For Treatment of Chronic Hepatitis B Virus Infection
ACTIVE NOT_RECRUITING150 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
For Treatment of Chronic Hepatitis B Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint
24 weeks post end of treatment

Secondary Endpoints

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)
24 weeks post end of treatment
Percentage of participants with treatment-emergent adverse events (TEAEs)
24 weeks post NRTI discontinuation
Percentage of participants with serious adverse events (SAEs)
24 weeks post NRTI discontinuation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNαEXPERIMENTALParticipants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNαEXPERIMENTALParticipants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

Interventions

NameTypeDescription
BRII-179BIOLOGICALBRII-179 will be given via intramuscular injection
BRII-835 (VIR-2218)DRUGBRII-835 will be given via subcutaneous injection
PEG-IFNαBIOLOGICALPEG-IFNα will be given via subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * 1\. Male or female aged 18-60 years. * 2\. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * 3\. Chronic HBV infection for ≥ 6 months. * 4\. On NRTI therapy for ≥ 6 months. Exclusion Criteria: * 1\. Any clinically significant chronic or acute medical condition that makes the part...

Countries:China
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Frequently asked questions about BRII-179

What is BRII-179 used for?

BRII-179 is an investigational monoclonal antibody being developed for the treatment of chronic hepatitis B virus (HBV) infection. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing BRII-179?

BRII-179 is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR. The company is conducting clinical trials to evaluate the safety and efficacy of BRII-179 in patients with chronic hepatitis B.

What phase is BRII-179 in?

BRII-179 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 2 trial is evaluating the drug in combination with other therapies for chronic hepatitis B virus infection.

What clinical trials is BRII-179 in?

BRII-179 is being studied in a Phase 2 clinical trial identified as NCT06491563, titled 'Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH).' The trial is active but not recruiting, with an enrollment of 150 participants in China.

Is BRII-179 being tested in combination with other drugs?

Yes, BRII-179 is being evaluated in combination with BRII-835 and PEG-IFNα in a Phase 2 clinical trial for chronic hepatitis B virus infection. The study is designed to investigate the efficacy and safety of these regimens, and it is being conducted in China.