VIR-3434 for Hepatitis B

Overseen By Jiayun Chen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must be taking: Nucleos(t)ide therapy

Must not be taking: Peginterferon, Immunosuppressives

Disqualifiers: Cirrhosis, Hepatocellular carcinoma, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 48 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test VIR-3434, a new treatment for chronic hepatitis B, to determine its effectiveness in clearing the virus from the body. Participants will receive the treatment every four weeks for 48 weeks, followed by a 48-week follow-up period. It suits individuals who have had hepatitis B for over six months and are on stable medication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in hepatitis B treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on stable nucleos(t)ide therapy for more than a year.

Is there any evidence suggesting that VIR-3434 is likely to be safe for humans?

Research has shown that VIR-3434 is generally safe and well-tolerated. One study found that a 300 mg dose of VIR-3434 was safe and manageable for participants. Additionally, data from both healthy volunteers and those with hepatitis B indicated that VIR-3434 did not cause major side effects. Overall, participants experienced good safety. This suggests that VIR-3434 could be a promising treatment for chronic hepatitis B, with a safety profile that supports further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VIR-3434 for Hepatitis B because it offers a fresh approach compared to current treatments like antiviral medications and immune modulators. Unlike these traditional options, VIR-3434 acts as a neutralizing antibody, targeting the virus directly and potentially preventing it from entering liver cells. Additionally, its subcutaneous injection form, administered every four weeks, could provide a more convenient dosing schedule compared to daily oral medications. This new mechanism of action and delivery method could lead to better outcomes and ease of use for patients managing Hepatitis B.

What evidence suggests that VIR-3434 might be an effective treatment for hepatitis B?

Research has shown that VIR-3434, the treatment under study in this trial, is a promising option for chronic hepatitis B. In studies with specially bred mice, this drug lowered the amount of the hepatitis B virus and reduced a virus protein called HBsAg in the blood. Lowering HBsAg is important because high levels are linked to ongoing infection. As a monoclonal antibody, the drug specifically targets and neutralizes the virus. These early results suggest that VIR-3434 could help remove the virus from the body, offering hope for those with chronic hepatitis B. ^{1 5 6 7 8}

Who Is on the Research Team?

Jordan Feld, MD, MPH

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals with chronic hepatitis B. Participants will be involved in the study for about 104 weeks, receiving VIR-3434 weekly for the first 48 weeks and then being followed up for another 48 weeks.

Inclusion Criteria

Quantitative HBsAg 500 - 10,000 IU/mL

I am not pregnant, breastfeeding, and agree to use effective birth control during the study.

I am not pregnant or I am postmenopausal.

Exclusion Criteria

estimated Glomerular Filtration Rate (eGFR) < 45 cc/min

Bilirubin > 40 µmol/L

I have a history of severe liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIR-3434 300 mg subcutaneous injection every 4 weeks for 48 weeks

48 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

12 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VIR-3434

Trial Overview The trial is testing VIR-3434, an experimental drug aimed at targeting and clearing the HBsAg of hepatitis B virus from the body. It's a Phase II study where all participants receive the actual medication without any placebo.

How Is the Trial Designed?

Group I: VIR-3434 Experimental Treatment 1 Intervention

VIR-3434 300 mg subcutaneous injection every 4 weeks\*48 weeks

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11653528/

Development of a highly potent anti-HBs monoclonal ... Potent broadly neutralizing antibody VIR-3434 controls hepatitis B and D virus infection and reduces HBsAg in humanized mice. J Hepatol 2023;79:1129–1138 ...

2. investors.vir.bio investors.vir.bio/news/news-details/2023/Vir-Biotechnology-Presents-New-Data-Evaluating-the-Potential-for-VIR-2218-and-VIR-3434-as-Therapies-for-Chronic-Hepatitis-B-and-Hepatitis-D-06-24-2023/default.aspx

News Details Preclinical data suggest the potential of VIR-2218 and VIR-3434 as treatment for the chronic suppression of hepatitis D virus infection.

3. journal-of-hepatology.eu journal-of-hepatology.eu/article/S0168-8278(23)04978-4/fulltext

Potent broadly neutralizing antibody VIR-3434 controls ... Taken together, our data demonstrate that HBC34/VIR-3434 is highly effective in reducing viremia and circulating HBsAg in mouse models of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04423393?term=AREA%5BConditionSearch%5D(Hepatitis%20B)%20AND%20AREA%5BInterventionSearch%5D(VIR-3434)&rank=4

Study of VIR-3434 in Healthy Volunteers and Patients With ... This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12038417/

Drug development for chronic hepatitis B functional cure Potent broadly neutralizing antibody VIR-3434 controls hepatitis B and D virus infection and reduces HBsAg in humanized mice. J Hepatol ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04423393

NCT04423393 | Study of VIR-3434 in Healthy Volunteers ... This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0168827823049784

Potent broadly neutralizing antibody VIR-3434 controls ... These data indicate that VIR-3434 neutralizes HBV infection not via blocking glycosaminoglycan-mediated attachment but at a later stage of infection. We next ...

8. investors.vir.bio investors.vir.bio/news/news-details/2025/Vir-Biotechnology-to-Present-Week-48-SOLSTICE-Clinical-Results-in-Hepatitis-Delta-at-AASLDs-The-Liver-Meeting-2025/default.aspx

Vir Biotechnology to Present Week 48 SOLSTICE Clinical ... Vir Biotechnology will present the following abstracts: Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR ...