Ridgeback Biotherapeutics announced the implementation of an expanded access protocol to ensure rapid access to its Ebola treatment, ansuvimab, in the Democratic Republic of the Congo (DRC). The Institut National de Recherche Biomédicale (INRB) of the DRC is conducting this open-label expanded access clinical trial, which initiated earlier this month. Ridgeback is providing study drug and operational support for this trial.

Formerly known as mAb114, ansuvimab has also been granted Orphan Drug Designation, Breakthrough Therapy Designation and Priority Review Designation as a treatment for Ebola virus disease by the U.S. Food and Drug Administration (FDA).

“While we are disheartened to see another Ebola outbreak emerge so quickly after the 2018–2020 outbreak in DRC, we are confident that the scientifically rigorous and dedicated team at the INRB will provide the leadership necessary to stop this local outbreak in Equateur province. The world owes a tremendous amount of gratitude to the skilled team at INRB – their focus and hard work helped to stop the international spread of Ebola in the past and they will succeed again. We are committed to helping our partners at the INRB fight this vicious virus,” Wendy Holman, CEO and co-founder of Ridgeback, said.  “It is important to note that so much of what we do has been made possible by the tremendous work of our partners, and specifically the scientific brilliance of Professor Jean-Jacques Muyembe-Tamfum, Director General of INRB and Dr. Nancy Sullivan, Chief of the Biodefense Research Section at the National Institute of Allergy and Infectious Diseases, Vaccine Research Center. The world is a much safer and better place as a result of their work. We are eager to make ansuvimab more widely available for those who need it most.”

“As the Principal Investigator of this trial, Professor Muyembe-Tamfum will lead the INRB team in their use of ansuvimab for Ebola patients. His pioneering scientific contributions have led to valuable discoveries, which have paved the way for the use of antibodies and convalescent serum in emerging infectious diseases. It is an honor to work with him once again to help people who are presently suffering from this deadly virus,” Dr. Sabue Mulangu, Senior Vice President of Global Medical Affairs for Ridgeback Biotherapeutics, said.

Ansuvimab is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. Dr. Sullivan and her team discovered that the survivor retained antibodies against Ebola 11 years after infection. The team isolated the antibodies, tested the most favorable ones in both laboratory and nonhuman primate studies, and selected ansuvimab as the most promising. Professor Muyembe-Tamfum was one of the scientists involved in the original detection of the Ebola virus in 1976, and played a key role in discovering ansuvimab. Ansuvimab development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C0009.