Therapy Areas: Infectious Diseases
Ridgeback Biotherapeutics wins FDA orphan drug designation for mAb114 for for Ebola
31 May 2019 -

Biotechnology company Ridgeback Biotherapeutics LP reported on Thursday the receipt of the US Food and Drug Administration's (FDA) orphan drug designation for the experimental mAb114 treatment for Ebola.

According to the company, mAb114 is a monoclonal antibody, a protein that binds to a single target on a pathogen and isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. The survivor reportedly retained antibodies against Ebola 11 years after infection.

The drug has completed a Phase 1 safety study and is currently being used to treat Ebola patients in Congo under two separate protocols.

Under the first protocol, the company will launch a randomised controlled trial to evaluate mAb114 for efficacy and safety in the treatment of Ebola patients in partnership with the World Health Organisation and led and sponsored by the DRC's National Institute for Biomedical Research (INRB) , the DRC Ministry of Health, the US National Institute for Allergy and Infectious Diseases (NIAID), the Alliance for International Medical Action (ALIMA) and other organisations.

As part of the second protocol, the company will begin an expanded access programme of mAb114 in line with the WHO ethical framework known as Monitored Emergency Use of Unregistered Interventions (MEURI), which allows for access to investigational therapeutics outside of clinical trials.