Human clinical trials may begin on an antiviral compound which was discovered and developed by Emory University and shows promise as a 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 EIDD-2801. The antiviral compound, which can be taken by mouth, is exclusively licensed to Ridgeback Biotherapeutics, LP (Ridgeback), a closely held biotechnology company. The FDA’s approval allows Ridgeback to initiate human clinical testing in the United States.
“We are thankful to FDA Commissioner Dr. Steven Hahn and his team at the Anti-Viral Division for the unprecedented speed in reviewing our submission, the guidance and the highly collaborative process that ensures this promising drug can advance into the clinical development as fast as possible,” says Wendy Holman, chief executive officer of Ridgeback.
“We also appreciate the guidance we have received from the Assistant Secretary of Preparedness and Response (ASPR), including discussions that occurred months before COVID-19 first emerged, to help Emory/DRIVE advance the development of EIDD-2801 as quickly as possible to address this global pandemic,” Holman adds.
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).
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).
Read more at Emory University
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