Imagine a safety net for people who have been exposed to a dangerous virus but aren't sick yet. Instead of just relying on vaccines, which might be too slow, this project tests using specialized antibodies as a shield to stop the virus from taking hold. It's like giving the body a pre-made defense system to block the infection immediately after contact.
Current Ebola vaccines may not be effective enough for high-risk contacts. There is a critical need for a proven post-exposure prophylaxis (PEP) strategy to prevent infection and reduce mortality.
A multi-country phase III clinical trial and a training program for staff on GCP/GLP and study-specific protocols.
If you are a biotech drug developer dealing with the need for new clinical evidence for antibody use — this project developed a phase III clinical trial that evaluates the efficacy of mAbs as post-exposure prophylaxis. This provides the necessary data to expand the approved use of existing treatments.
If you are an international health NGO dealing with high mortality rates during outbreaks — this project developed a PEP strategy for high-risk contacts that can be implemented across multiple countries. This reduces the number of new cases and saves lives during epidemics.
If you are a CRO dealing with the difficulty of conducting trials in volatile regions — this project developed a multi-site, multi-country trial network across 7 countries. This creates a blueprint for executing complex phase III trials in Central and West Africa.
Based on available project data, the specific cost per dose of the monoclonal antibodies is not provided; the project focuses on efficacy evaluation.
The project tests existing monoclonal antibodies (Ansuvimab and REGN-EB3) in a phase III trial, meaning the manufacturing process for these drugs already exists at scale.
Based on available project data, the IP details are not specified, but the project involves 11 partners including the Institut National de la Santé et de la Recherche Médicale.
The project runs from 2024-06-01 to 2027-05-31, during which the phase III trial and strategy definition will occur.
The project aims to advocate for PEP implementation in affected countries and strengthen the capacities of clinical researchers.
The consortium is heavily research-oriented, consisting of 11 partners across 7 countries, with 6 research institutions and 3 universities. There is a notable absence of industry partners (0%), indicating that the project is currently in a clinical validation phase rather than a commercialization phase, led by a French public research institute.
Contact the Institut National de la Santé et de la Recherche Médicale (INSERM) in France.
Contact us to track the phase III results of EBO-PEP for pharmaceutical market entry.
