Drugs / Tobevibart
Tobevibart
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06070051 | Sep 2023 → Mar 2026 overdue | chronic hepatitis B virus infection | Virion Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05484206 | Sep 2022 → Dec 2025 | cirrhosis of liver | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04423393 | May 2020 → Oct 2022 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05612581 | May 2023 → Oct 2024 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07142811 | Aug 2025 → Nov 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06216470 | Mar 2024 → Dec 2029 expected | chronic hepatitis B virus infection | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT05461170 | Sep 2022 → Nov 2031 expected | hepatitis D virus infection | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04856085 | Jul 2021 → Mar 2026 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07128550 | Jul 2025 → Dec 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06903338 | Mar 2025 → Dec 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-01-12 | Vir Biotechnology, Inc. | Results Vir Biotechnology Provides Updates on Chronic Hepatitis Delta and Oncology Programs and Upcoming 2026 Clinical Milestones vir.bio ↗
Positive, updated Phase 2 SOLSTICE data showed combination of tobevibart and elebsiran is well tolerated and achieved undetectable HDV RNA in 88% of chronic hepatitis delta participants evaluable at 96 Weeks of treatment |
| 2025-11-09 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces AASLD The Liver Meeting® Presentation & New England Journal of Medicine Publication of Phase 2 Data Demonstrating Tobevibart & Elebsiran Combination Deliver High Rates of Undetectable HDV RNA with Favorable Safety Profile vir.bio ↗
Data demonstrate that 66% (21/32) of participants with CHD receiving a monthly dose of the combination of tobevibart and elebsiran achieved and sustained HDV RNA TND at 48 weeks. |
| 2025-05-09 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces Preliminary 24-Week Post-End of Treatment Data for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B From the MARCH Study vir.bio ↗
HBsAg loss 24 weeks post-end of treatment achieved in 17% and 21% of participants with low baseline HBsAg receiving tobevibart + elebsiran without or with PEG-IFNα, respectively |
| 2024-12-12 | Vir Biotechnology, Inc. | Regulatory Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta vir.bio ↗ |
| 2024-11-18 | Vir Biotechnology, Inc. | Regulatory Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency vir.bio ↗ |
| 2024-11-18 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program vir.bio ↗
Vir Biotechnology, Inc. (NASDAQ:VIR) today announced positive results from the SOLSTICE Phase 2 clinical trial evaluating tobevibart alone, or in combination with elebsiran, in people with chronic hepatitis delta (CHD). |
| 2024-11-15 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting vir.bio ↗
The study demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens. |
| 2024-06-26 | Vir Biotechnology, Inc. | Regulatory Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection vir.bio ↗
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. |
| 2024-06-05 | Vir Biotechnology, Inc. | Results Tobevibart Monotherapy and Combination Therapy with Elebsiran Achieved High Virologic Response and ALT Normalization in People Living with the Hepatitis Delta Virus After 12 and 24 Weeks of Treatment vir.bio ↗ |
| 2024-05-14 | Brii Biosciences Limited | Regulatory Brii Biosciences Announces Two Breakthrough Therapy Designations for BRII-877 and BRII-835 Building on Extensive Clinical Evidence from Multiple Phase 2 Studies briibio.com ↗
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). |
| 2023-11-13 | Vir Biotechnology, Inc. | Results Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting® 2023 vir.bio ↗
Specifically, at 24 weeks, 15.0% and 14.3% of participants achieved HBsAg loss at EOT for VIR-3434 + VIR-2218 and VIR-2218 + VIR-3434 + PEG-IFN-α, respectively. |
| 2023-06-25 | Brii Biosciences Limited | Results Brii Bio Announces New Data from Partners Underscoring Potential for HBV Functional Cure at EASL™ Congress 2023 briibio.com ↗
In another oral presentation, Vir announced 48-week post-treatment data from Part A of the Phase 2 MARCH trial. |
| 2023-06-24 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 as Therapies for Chronic Hepatitis B and Hepatitis D vir.bio ↗
new pharmacokinetics (PK) data support the safety, tolerability and antiviral activity of a 300 mg dose of VIR-3434 |
| 2022-11-06 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 to Achieve a Functional Cure for Chronic Hepatitis B Virus (HBV) Infection vir.bio ↗
These data showed that VIR-2218 and VIR-3434, an investigational HBsAg-targeting monoclonal antibody engineered to potentially act as a therapeutic vaccine, are additive in reducing HBsAg. |
| 2022-10-31 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces Multiple Abstracts Highlighting New Hepatitis B Data Accepted for Presentation at AASLD’s The Liver Meeting® 2022 vir.bio ↗
data indicating that a single 75 or 300 mg dose of VIR-3434 is associated with reductions in hepatitis B viral DNA and HBsAg |
| 2022-06-25 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces New Clinical Data From its Broad Hepatitis B Program vir.bio ↗
Phase 1 results evaluating VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg or 300 mg) resulted in a rapid reduction of HBsAg, with the largest and most durable response noted with the 300 mg dose. |
| 2022-04-27 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces New Data From the MARCH Hepatitis B Trial, Unveils New Hepatitis D Clinical Program and Highlights Broad Hepatitis Portfolio at Virtual Hepatitis Portfolio R&D Day vir.bio ↗ |
| 2021-11-12 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 to Achieve a Functional Cure for Chronic Hepatitis B Virus (HBV) Infection at AASLD The Liver Meeting® vir.bio ↗
Preliminary results from an ongoing Phase 2 clinical trial of VIR-2218, alone or in combination with other therapies, and an ongoing Phase 1 clinical trial of VIR-3434, continue to demonstrate rapid and notable reductions in hepatitis B surface antigen (HBsAg) and positive safety findings. |
| 2021-06-25 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents New Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 in Patients with Chronic Hepatitis B Virus Infection at the International Liver Congress 2021 vir.bio ↗
Results demonstrate positive safety profiles and a reduction in HBsAg for two novel HBV therapies administrated as monotherapy or in combination with other agents |
| 2021-01-26 | Vir Biotechnology, Inc. | Results Initial Data from Ongoing Phase 1 Trial of VIR-3434 for Chronic Hepatitis B Virus Infection Demonstrates Significant and Rapid Reduction in Hepatitis B Surface Antigen vir.bio ↗ |
All press releases naming this drug 26 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tobevibart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07142811 ↗ |
| Known as | HBC34-v35-LS-XX2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314621 ↗ |
| Known as | LS-GAALIE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314621 ↗ |
| Known as | VIR-3434 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04856085 ↗ |
| Action | Inhibit | “Tobevibart, a human monoclonal antibody against hepatitis B surface antigen (HBsAg), neutralizes HBV and HDV.” PMID 40882923 ↗ Aug 2025 |
| Modality | Monoclonal antibody | “Tobevibart (VIR-3434) is an investigational, Fc-engineered human mAb that targets HBsAg with pan-genotypic neutralizing activity.” PMID 41586499 ↗ Jan 2026 |
| Route | Subcutaneous | “VIR-3434 given by subcutaneous injection” NCT04423393 ↗ |