Human Testing of Promising Potential Treatment for COVID-19 Begins after FDA Approval

The US Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovations at Emory (DRIVE), LLC (Atlanta, GA, USA) for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics LP (Miami, FL, USA). This will allow Ridgeback to initiate human clinical testing of EIDD-2801 in the US.

Ridgeback is a biotechnology company focused on orphan and infectious diseases, and is in the process of completing a Biologics Licensing Application with the FDA for mAb114 (ansuvimab) for the treatment of Ebola. DRIVE is a non-profit LLC wholly owned by Emory University that operates like an early stage biotechnology company, with a focus on efficiently translating discoveries to address viruses of global concern. DRIVE's mission is to discover and develop antiviral drugs for emerging infections, pandemic threats, and biodefense (e.g. COVID-19, swine flu, bird flu, dengue, chikungunya, Ebola, Zika, and viral encephalitis). 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 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. In addition to activity against coronaviruses, EIDD-2801, in laboratory studies, has demonstrated activity against seasonal and bird influenza, respiratory syncytial virus, chikungunya virus, Ebola virus, Venezuelan equine encephalitis virus, and Eastern equine encephalitis virus.

"FDA's prompt approval of our IND allows us to initiate human testing for EIDD-2801 as quickly as possible," said 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."

"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."

Related Links:
Ridgeback Biotherapeutics LP
Drug Innovations at Emory (DRIVE), LLC