Drugs / BRII-835
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06650852 | Oct 2024 → Jul 2026 overdue | chronic hepatitis B virus infection | Brii Biosciences Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT06491563 | Aug 2024 → Dec 2026 expected | chronic hepatitis B virus infection | Brii Biosciences Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05970289 | Aug 2023 → Jul 2025 overdue | chronic hepatitis B virus infection | Brii Biosciences Limited | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 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 |
| 2024-11-19 | 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. |
| 2024-06-07 | 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. |
| 2024-05-14 | 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. |
| 2023-02-15 | 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. |
| 2022-06-25 | 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). |
All press releases naming this drug 30 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BRII-835 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06491563 ↗ |
| Known as | VIR-2218 | “BRII-835 (VIR-2218)” NCT06650852 ↗1“BRII-835 (VIR-2218)” NCT06491563 ↗ |
| Route | Subcutaneous | “BRII-835 will be given via subcutaneous injection” NCT05970289 ↗ |