Drugs / ROMLUSEVIMAB
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04691180 | Jan → Sep 2021 | COVID-19 | Brii Biosciences Limited | Completed | No outcome recorded |
| Phase 1 | NCT04479644 | Jul 2020 → Feb 2021 | COVID-19 | Brii Biosciences Limited | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04787211 | Jun → Dec 2021 | COVID-19 | Brii Biosciences Limited | Completed | No outcome recorded |
| Phase 2 | NCT04770467 | Feb 2021 → Oct 2022 | COVID-19 | Brii Biosciences Limited | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04518410 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT05780424 | Dec 2020 → Jun 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04501978 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2022-03-16 | Brii Biosciences Limited | Regulatory Brii Bio Announces that National Health Commission of China Adds Amubarvimab/Romlusevimab Combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) briibio.com ↗
Brii Bio Announces that National Health Commission of China Adds Amubarvimab/Romlusevimab Combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) |
| 2021-12-12 | Brii Biosciences Limited | Results Brii Bio Announces Amubarvimab/Romlusevimab Combination Retains Neutralizing Activity Against Omicron SARS-CoV-2 Variant briibio.com ↗
In vitro tests against the omicron pseudovirus show that Amubarvimab/Romlusevimab Combination retains neutralizing activity against the Omicron variant and other variants of concern such as Delta and Delta Plus |
| 2021-12-09 | Brii Biosciences Limited | Regulatory Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China briibio.com ↗
Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China |
| 2021-10-09 | Brii Biosciences Limited | Regulatory Brii Bio Initiates Submission of Emergency Use Authorization Filing to U.S. FDA for BRII-196/BRII-198, its Monoclonal Antibody Combination Therapy for Non-Hospitalized COVID-19 Patients at High Risk of Clinical Progression to Severe Disease briibio.com ↗ |
| 2021-10-04 | Brii Biosciences Limited | Results Brii Bio Presents Positive Phase 3 Data on BRII-196/BRII-198, the Company’s SARS-CoV-2 Monoclonal Neutralizing Antibody Combination Therapy, in an Oral Late-Breaker Presentation at IDWeek 2021 briibio.com ↗
Overall, BRII-196/BRII-198 reduced the risk of hospitalization and death over placebo by 78% in 837 outpatients at high risk of clinical progression. |
| 2021-08-25 | Brii Biosciences Limited | Results Brii Biosciences Announces Positive Data from the Phase 3 ACTIV-2 Trial Evaluating Combination BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients briibio.com ↗
The monoclonal antibody combination therapy reduced the combined endpoint of hospitalizations and death by 78% over placebo in 837 COVID-19 patients at high risk of clinical progression |
| 2021-04-29 | Brii Biosciences Limited | Results Brii Biosciences Monoclonal Antibodies, BRII-196 and BRII-198, Progress to Phase 3 in NIH ACTIV-2 Trial in Ambulatory COVID-19 Patients briibio.com ↗
today announced that its monoclonal antibody combination therapy, BRII-196 and BRII-198, met pre-specified safety and efficacy criteria, permitting continuation of Phase 3 of the ACTIV-2 trial as recommended by a DSMB composed of independent subject matter experts. |
| 2021-03-03 | Brii Biosciences Limited | Results Brii Biosciences Antibody Combination Will Not Progress into a Phase 3 Study Evaluating the Treatment of SARS-CoV-2 in Hospitalized Patients briibio.com ↗
Brii Biosciences (“Brii Bio”), a multi-national company , today announced that its antibodies BRII-196 and BRII-198 failed to meet pre-specified efficacy criteria permitting expansion into the Phase 3 component of ACTIV-3. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ROMLUSEVIMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650383 ↗ |
| Known as | BRII-198 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04691180 ↗ |
| Modality | Monoclonal antibody | “Human Monoclonal Antibody” NCT04479644 ↗ |
| Route | Intravenous | “BRII-198 Administered Intravenously” NCT04479644 ↗ |