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BRII-835

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Jun 18, 2024

Target and mechanism

Molecular targethepatitis B virus
Target classVirus
ModalitySmall molecule

Also known as BRII-835 (VIR-2218)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

BRII-835 · 1 trial · 1 indication

Phase 2 1
NCT04749368Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) InfectionHepatitis B, Chronic
COMPLETED91 Analytics
PHASE2COMPLETED
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Hepatitis B, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
up to Week 96
Number of participants with Adverse Events (AE)
up to Week 96
Number of participants with Serious Adverse Events (SAE)
up to Week 96
Number of participants with abnormalities in clinical laboratory tests
up to Week 96
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTALParticipants will receive BRII-835 (VIR-2218) for 32 weeks
Cohort BEXPERIMENTALParticipants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Cohort CEXPERIMENTALParticipant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40

Interventions

NameTypeDescription
BRII-835 (VIR-2218)DRUGBRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601) with IFN-αBIOLOGICALBRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BRII-179 (VBI-2601)BIOLOGICALBRII-179 (VBI-2601) will be administered by intramuscular injection
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Male or female aged 18 - 60 * Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2 * Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for...

Countries:AustraliaChinaNew ZealandSingaporeSouth KoreaThailand
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Frequently asked questions about BRII-835

What is BRII-835 used for?

BRII-835 is an investigational small molecule 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. The drug is being studied as part of a combination therapy approach to address chronic HBV infection.

What does BRII-835 target?

BRII-835 targets the hepatitis B virus. As a small molecule designed to act against the virus itself, it is being investigated for its potential role in treating chronic hepatitis B infection. The drug is being evaluated in combination with other therapies to improve treatment outcomes for patients with this condition.

Who makes BRII-835?

BRII-835 is being developed by Vir Biotechnology, Inc., a company traded on the stock exchange under the ticker symbol VIR. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for the treatment of chronic hepatitis B virus infection.

What phase is BRII-835 in?

BRII-835 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities for commercial use. The drug is being studied in clinical trials to assess its safety and efficacy in patients with chronic hepatitis B virus infection.

What clinical trials is BRII-835 in?

BRII-835 has been studied in one completed Phase 2 clinical trial with the identifier NCT04749368. This trial investigated the safety and efficacy of BRII-835 in combination with BRII-179 for treating chronic hepatitis B virus infection. The study enrolled 91 participants across multiple countries including Australia, China, New Zealand, Singapore, South Korea, and Thailand.

Is BRII-835 the same as VIR-2218?

Yes, BRII-835 is also known as VIR-2218. The drug is being developed by Vir Biotechnology, Inc. under the ticker symbol VIR. It is an investigational small molecule in Phase 2 clinical development for the treatment of chronic hepatitis B virus infection.