Closely-held US biotech firm Ridgeback Biotherapeutics has entered into a patent license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for intellectual property related to the monoclonal antibody mAb114, an experimental treatment for Ebola.
mAb114 has completed a Phase I safety study and is currently being administered to some Ebola patients in the Democratic Republic of Congo under two separate protocols.
The experimental treatment was first made available under a compassionate use program known as Monitored Emergency Use of Unregistered Interventions (MEURI), an ethical framework developed by the World Health Organization (WHO) which allows for access to investigational therapeutics outside of clinical trials.
In November 2018, a randomized controlled trial of mAb114 and other investigational Ebola therapeutics began.
The experimental treatments are being evaluated for efficacy and safety for the treatment of Ebola patients.
This trial is coordinated by the WHO, and led and sponsored by the DRC's National Institute for Biomedical Research (INRB) in partnership with the DRC Ministry of Health, NIAID, the Alliance for International Medical Action (ALIMA) and other organizations.
In preclinical studies, mAb114 has shown protection against Ebola in non-human primates with only one dose of treatment.
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