FDA approves human testing of investigational drug against Covid 19

ATLANTA and MIAMI,-- 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.

EIDD-2801 is an orally bioavailable 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.

The compound was exclusively licensed to Ridgeback Biotherapeutics, LP (Ridgeback), a closely held biotechnology company. This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 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," said 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."

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).

"FDA's prompt approval of our IND allows us to initiate human testing for EIDD-2801 as quickly as possible," says George Painter, Ph.D., director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE. "We are grateful to our collaborators for helping us to assemble this application quickly, and to the FDA for expediting the process. An orally available antiviral medication would be a critical weapon for fighting COVID-19."

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.

"We look forward to our continued work with the highly experienced drug development team at DRIVE and the dedicated medical, public health and governmental personnel who are on the frontlines of this pandemic – in the United States and abroad," says Wendy Holman, CEO of Ridgeback Biotherapeutics. "The ability to deliver promising treatments to patients in need is what makes us excited to come to work every day. Ridgeback brings its unique perspective, honed by our success developing an Ebola therapeutic during the 2018-2020 outbreak in the DR Congo, to help advance EIDD-2801 for the treatment of diseases that are critical to pandemics and global health."

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