The Biomedical Advanced Research and Development Authority (BARDA) intends to provide $14 million and expertise support for the advanced development of an investigational Ebola treatment being pursued by Ridgeback Biotherapeutics of Miami.
Ridgeback is manufacturing the therapeutic drug known as mAb114, and intends to apply for licensure with the U.S. Food and Drug Administration — an effort BARDA will assist. That therapeutic is a single monoclonal antibody that acts by binding to virus proteins, thus reducing their ability to infect human cells. The antibody was initially isolated and developed by scientists from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in collaboration with the Institut National de Recherche Biomedicale, the Institute for Research in Biomedicine, and the U.S. Army Research Institute of Infectious Diseases.
“Effective Ebola therapeutics are essential in saving lives not only in the current outbreak in the DRC but also in future outbreaks anywhere in the world and to discourage any potential use of this virus in bioterrorism,” BARDA Director Rick Bright said. “Combating this horrific disease requires every tool we can provide to healthcare providers and patients.”
The mAb114 drug is currently being utilized in the Democratic Republic of the Congo to help combat its ongoing Ebola outbreak, under a clinical trial known as PALM. NIAID and the National Biomedical Research Institute are co-sponsoring that trial.
The product has already obtained an FDA Breakthrough Therapy Designation, which helps it move further along the approval process. Participating companies can submit parts of their application on a rolling basis and work more closely with FDA officials in pushing for approval.