Recent Updates
Recently added Catalysts

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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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)PHASE2 ACTIVE NOT_RECRUITING 150Aug 6, 2024Jun 1, 2027Dec 30, 202412 China
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06491563primaryCompletionDate: changed
LOWMay 24, 2026NCT06491563studyFirstPostDate: changed