Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) , and Clinical Studies (14) ] . FDA label
Also known as REGN-E3B
Inmazeb · 1 trial · 1 indication
The level will be evaluated with a pseudo-type plaque reduction neutralization test
| Arm | Type | Description |
|---|---|---|
| Ervebo 72 million PFU | ACTIVE_COMPARATOR | The control arm (vaccination alone) will serve to characterize the immune response to the vaccine and it will be used as a comparator of vaccine immune response in the intervention arms. Administration at D1. |
| Inmazeb 150mg/kg | ACTIVE_COMPARATOR | This second control arm of mAb alone will serve to characterize the pharmacokinetic profile of mAb in the Guinean population. Administration at D1. |
| Inmazeb 150mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 3, is a concomitant administration of the antibody and the vaccine at D1. |
| Inmazeb 50mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 4, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 15 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Inmazeb 10mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 5, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 57 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Inmazeb 0.7mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 6, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 169 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Name | Type | Description |
|---|---|---|
| Ervebo | BIOLOGICAL | Administration of r-VSV-ZEBOV vaccine |
| Inmazeb | DRUG | Administration of Inmazeb |
Inclusion Criteria: * Available for the duration of the protocol follow-up; * Consent to participate ; * Agreed not to participate in another clinical research study until the end of the trial follow-up. Exclusion Criteria: * Prior history of EVD (self-reported); * Previous vaccination with r-VSV...
Inmazeb is being studied for Ebola Virus Disease. It is an investigational therapy in clinical development, and Regeneron Pharmaceuticals is evaluating it in a Phase 2 trial that includes healthy adult volunteers. The research focuses on its use in the context of Ebola virus prevention and treatment strategies.
Inmazeb is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The company is the sponsor of the ongoing clinical program for the drug in Ebola Virus Disease.
Inmazeb is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The current Phase 2 trial is active but not yet recruiting participants.
Inmazeb is being studied in one clinical trial, NCT05202288, titled "Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers." This Phase 2 trial has a planned enrollment of 132 participants and is active controlled.
No, Inmazeb and Ervebo are different products. Inmazeb is an investigational therapy being developed by Regeneron for Ebola Virus Disease, while Ervebo is a vaccine used in the same disease area. The ongoing Phase 2 trial NCT05202288 is evaluating the impact of the timing between Inmazeb administration and Ervebo vaccination.