FDA approved Emory University human clinical trials for Emory COVID-19 antiviral

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On Apr. 7, 2020, the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), wholly owned by Emory University, for EIDD-2801. The antiviral compound, which can be taken by mouth, is exclusively licensed to Ridgeback Biotherapeutics. The FDA’s approval allowed Ridgeback to initiate human clinical testing in the U.S.

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 and for Venezuelan and Eastern equine encephalitis virus by the Defense Threat Reduction Agency.

EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19. It 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).

Ridgeback and DRIVE have established a partnership to advance EIDD-2801 through clinical development and to optimize availability during the current COVID-19 pandemic. EIDD-2801 was exclusively licensed to Ridgeback in March 2020.

EIDD-2801 is an orally available form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung.

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Source: Emory University
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