mAb114 is currently under study in the Democratic Republic of the Congo through an Expanded Access Protocol administered as part of the Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola virus disease (MEURI).
Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1 - This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK on Friday April 10th. EIDD-2801 is a direct acting anti-viral nucleoside analogue. Essentially, EIDD-2801 tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself. This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses when treated with EIDD-2801. EIDD-2801 has been shown to treat MERS and SARS (two severe coronavirus infections) in animals when given after an infection has been established. When given prophylactically EIDD-2801 is able to prevent significant manifestations of disease in animals challenged with MERS and SARS.
FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19 - The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics. This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States. EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA).