Drugs / VIR-2218
VIR-2218
Trials 15
| 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 | NCT05844228 | Jun 2023 → Mar 2025 | impaired renal function disease | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05484206 | Sep 2022 → Dec 2025 | cirrhosis of liver | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05612581 | May 2023 → Oct 2024 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03672188 | Nov 2018 → Sep 2020 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07142811 | Aug 2025 → Nov 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06092333 | Jan 2025 → Feb 2028 expected | chronic hepatitis B virus infection | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not 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 | NCT04891770 | Aug 2021 → Jan 2024 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT04856085 | Jul 2021 → Mar 2026 | chronic hepatitis B virus infection | Vir Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04749368 | Apr 2021 → Jul 2023 | chronic hepatitis B virus infection | Brii Biosciences Limited | Completed | No outcome recorded |
| Phase 2 | NCT04507269 | Aug 2020 → Sep 2021 | chronic hepatitis B virus infection | Brii Biosciences Limited | Completed | No outcome recorded |
| Phase 2 | NCT04412863 | Jul 2020 → Mar 2024 | 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 · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-07-03 | Brii Biosciences Limited | Results Brii Bio Announces Topline End-of-Treatment Data from Phase 2b ENRICH and ENHANCE Studies for the Treatment of Chronic Hepatitis B briibio.com ↗
End-of-treatment data from ENRICH demonstrated higher HBsAg loss rates, consistent with ENSURE Cohort 4, confirming the role of BRII-179 in priming immune responses for functional cure strategies |
| 2026-05-27 | Brii Biosciences Limited | Results Brii Bio Presents Late-Breaking Data from Its Phase 2 ENSURE Study at EASL Congress 2026, Further Supporting the Potential Role of BRII-179 in Achieving Durable Immunological Control of HBV briibio.com ↗
Final results from the ENSURE study demonstrate that the addition of elebsiran resulted in a higher functional cure rate compared with pegylated interferon alfa ( PEG-IFNα ) alone |
| 2026-04-26 | Brii Biosciences Limited | Results Brii Bio Presents Cross-Study Analysis of Post-Treatment HBsAg Rebound at APASL 2026 briibio.com ↗
Participants achieving HBsAg loss with pegylated interferon alfa ( PEG -IFNα) ± elebsiran or BRII-179 demonstrated favorable off-treatment clinical outcomes, with most HBsAg rebounds <10 IU/mL and HBV DNA rebound infrequent and not associated with clinically significant ALT elevation. |
| 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 |
| 2025-11-10 | Brii Biosciences Limited | Results Brii Biosciences Presents Late-Breaking Data from Ongoing Phase 2 ENSURE Study at AASLD 2025, Reinforcing BRII-179’s Potential as a Curative Treatment for Chronic Hepatitis B briibio.com ↗
Cohort 4 follow-up confirms durable h epatitis B surface antigen ( HBsAg ) loss at 24 weeks post end of treatment (EOT) in BRII-179 anti-HBs respon ders treated with elebsiran plus pegylated interferon alfa (PEG-IFNα) |
| 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. |
| 2025-11-07 | Brii Biosciences Limited | Results Brii Biosciences Announces Publication of Phase 2 ENSURE Study Results in Nature Medicine briibio.com ↗ |
| 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 |
| 2025-05-08 | Brii Biosciences Limited | Results Brii Bio Presents Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study at EASL Congress 2025, Suggesting BRII-179’s Role in Advancing Higher HBsAg Loss briibio.com ↗
24 Week follow-up results from Cohorts 1-3 of the ENSURE study demonstrated sustained off-treatment benefits of elebsiran + PEG-IFNα combination therapy vs PEG-IFNα alone |
| 2025-04-24 | Brii Biosciences Limited | Results Brii Bio to Present Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study in Participants with Chronic Hepatitis B Virus Infection at EASL 2025 briibio.com ↗
Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved faster and higher rate of hepatitis B virus surface antigen seroclearance on elebsiran plus peginterferon-alfa: end of treatment data from ENSURE study |
| 2025-03-30 | Brii Biosciences Limited | Results Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179’s Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification briibio.com ↗
48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα |
| 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 ↗ |
| 2024-11-19 | Brii Biosciences Limited | Results Brii Bio Delivers First Head-to-Head Comparison of siRNA (Elebsiran) and PEG-IFNα Combination versus PEG-IFNα Alone at AASLD’s The Liver Meeting ® 2024, Demonstrating Higher Loss of HBV Surface Antigen by Combining with siRNA briibio.com ↗
The ENSURE 48-week end-of-treatment (EOT) data demonstrated that 26.3% (5/19) or 33.3% (6/18) of participants receiving 200 mg or 100 mg elebsiran in combination with PEG-IFNα versus 5.6% (1/18) receiving PEG-IFNα alone achieved HBsAg seroclearance at EOT. |
| 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. |
| 2024-06-07 | Brii Biosciences Limited | Results Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials at EASL™ Congress 2024 briibio.com ↗
Pre-S1-specific T cell response targeting a region adjacent to sodium taurocholate cotransporting polypeptide (NTCP) was identified to be associated with high levels of HBsAg reduction in some participants receiving BRII-835 (elebsiran) and BRII-179. |
| 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). |
| 2023-11-14 | Brii Biosciences Limited | Results Brii Bio Presents New Data Highlighting Progress Towards Achieving HBV Functional Cure at AASLD’s The Liver Meeting ® 2023 briibio.com ↗
Similar PKprofiles between patients enrolled in the Asia-Pacific region and mainland China demonstrate that Chinese ethnic background from mainland China has no apparent impact, which could serve as a bridge to support mainland China’s participation in future global trials for further evaluation of BRII-835. |
| 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 ↗
16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment; Two of the five participants had baseline HBsAg levels greater than 1,000 IU/mL. |
| 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 ↗
16% (5/31) achieved sustained HBsAg loss 24 weeks following the end of treatment. |
| 2023-02-15 | VBI Vaccines Inc. | Results VBI Vaccines Announces Presentation of Interim Phase 2 Data Evaluating Combination of VBI-2601 (BRII-179) and BRII-835 for the Treatment of Chronic Hepatitis B vbivaccines.com ↗
VBI-2601 (BRII-179) and BRII-835 combination was generally well-tolerated with no new safety signals observed |
| 2023-02-15 | Brii Biosciences Limited | Results Brii Biosciences Announces Interim Results from Phase 2 Study Evaluating Combination BRII-835 and BRII-179 in Development for HBV Functional Cure briibio.com ↗
All cohorts achieved HBsAg reduction at the end of treatment with a mean decrease of -1.7 to -1.8 log 10 IU/mL. |
| 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 ↗
Additionally, 48 weeks of VIR-2218 plus PEG-IFN-α provided greater reductions in hepatitis B surface antigen (HBsAg) (mean decrease of -2.9 log10 IU/mL) compared to VIR-2218 alone or with shorter regimens of the combination. |
| 2022-06-25 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces New Clinical Data From its Broad Hepatitis B Program vir.bio ↗
In summary, data presented at ILC demonstrated that a six-dose regimen of VIR-2218 provided greater and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log10 IU/mL reduction during the trial. |
| 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 ↗ |
| 2022-03-31 | Brii Biosciences Limited | Results Brii Bio Presents New Data on BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022 briibio.com ↗
The data demonstrate that BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), results in dose-dependent reduction in hepatitis B surface antigen (HBsAg) in Chinese patients with chronic HBV infection who received two doses of BRII-835 (VIR-2218). |
| 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 ↗
In summary, data presented this week demonstrate the promising safety profile and potential durable response of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), through 48 weeks. |
| 2020-08-20 | Vir Biotechnology, Inc. | Results Vir Biotechnology Presents Data on VIR-2218 from Clinical Studies for the Treatment of Hepatitis B at the EASL Digital International Liver Congress™ vir.bio ↗
The data demonstrate that two monthly doses of VIR-2218 resulted in substantial, dose-dependent and durable reductions in hepatitis B surface antigen (HBsAg), a marker of active hepatitis B infection. |
| 2020-04-15 | Vir Biotechnology, Inc. | Results VIR-2218 Demonstrates Dose-Dependent and Durable Reductions of Hepatitis B Surface Antigen in Phase 1/2 Trial vir.bio ↗
Similar HBsAg reductions were observed in both HBeAg- and HBeAg+ patients. |
| 2020-01-13 | Vir Biotechnology, Inc. | Results Vir Biotechnology to Provide Pipeline Update at 38th Annual J.P. Morgan Healthcare Conference vir.bio ↗
All HBeAg negative and positive patients who received two doses of 200 mg of VIR-2218 (n=6) achieved at least a 1.0 log10 decline in HBsAg. |
| 2019-11-22 | Alnylam Pharmaceuticals | Results Alnylam Announces 2020 Product and Pipeline Goals and Provides Updates at R&D Day alnylam.com ↗
Announces Initial Positive Clinical Results with ALN-AAT02 and ALN-HBV02 (VIR-2218), Providing Human Proof of Concept for “Enhanced Stabilization Chemistry Plus” (ESC+) GalNAc Conjugate Delivery Technology |
All press releases naming this drug 48 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VIR-2218 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05484206 ↗ |
| Known as | BRII-835 | “HBV-targeted siRNA elebsiran (BRII-835)” PMID 40043858 ↗ Mar 2025 |
| Known as | elebsiran | “VIR-2218 (elebsiran), a small interfering RNA agent against HBV transcripts, reduces HBsAg concentrations.” PMID 39389081 ↗ Oct 20244“HBV-targeted siRNA elebsiran (BRII-835)” PMID 40043858 ↗ Mar 2025 |
| Action | Inhibit | “VIR-2218 was designed to silence HBV transcripts” PMID 34741731 ↗ Nov 2021 |
| Modality | Small interfering RNA (siRNA) | “a small interfering RNA agent against HBV transcripts” PMID 39389081 ↗ Oct 2024 |
| Route | Subcutaneous | “VIR-2218 given by subcutaneous injection” NCT03672188 ↗ |