Drug Innovations at Emory (DRIVE) LLC, and Ridgeback Biotherapeutics LP have announced a collaboration to rapidly advance DRIVE's EIDD-2801, a promising oral COVID-19 treatment, into human testing. DRIVE is a not-for-profit biotechnology company wholly owned by Emory University, and Ridgeback is a closely-held biotechnology company based in Miami.

This collaboration combines Ridgeback's unique experience advancing drug development efforts in the midst of the Ebola virus disease outbreak with the experience that the DRIVE executive team has in antiviral drug development and commercialization.

Under the collaboration, Ridgeback has exclusively licensed DRIVE's EIDD-2801, a promising potential coronavirus treatment for COVID-19, which has broad spectrum activity against a number of diseases of extreme public health concern, including influenza, SARS, MERS, chikungunya, and equine encephalitis (VEE and EEE). EIDD-2801 prevents the replication of multiple strains of coronavirus in vitro, and has been shown to have potent activity against SARS-CoV and MERS-CoV in animal models of infection. Ridgeback Biotherapeutics will be responsible for advancing this promising therapeutic through clinical development and ensuring that EIDD-2801 is available during the current pandemic.

"With EIDD-2801 close to entering clinical trials for influenza and its activity against the SARS and MERS coronaviruses, we immediately recognized that EIDD-2801 had the potential for treating COVID-19. Based on our extensive testing, we believe EIDD-2801 will be effective in treating individuals that have been sickened by COVID-19," says George Painter, PhD, director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE. 

"Given Ridgeback Biotherapeutics' experience in accelerating the development of potential therapeutics in outbreak settings and its proven commitment to global health, we are confident that Ridgeback can quickly advance EIDD-2801 into clinical trials for COVID-19 and initiate steps toward ensuring a rapid development path for this promising drug."

Ridgeback Biotherapeutics has unique experience meeting the challenges of developing novel drug treatments during an ongoing disease outbreak. In 2018, at the beginning of the Ebola outbreak in the Democratic Republic of the Congo, Ridgeback Biotherapeutics licensed mAb114 (ansuvimab), a promising Ebola therapeutic, from NIAID's Vaccine Research Center. Ansuvimab demonstrated a highly statistically significant survival benefit, as measured by a reduction in 28-day mortality, in the PALM randomized control trial. Ridgeback is currently completing its Biologics Licensing Application submission with the U.S. Food and Drug Administration (FDA) for commercial licensure of ansuvimab.

Under the EIDD-2801 licensing agreement, Ridgeback Biotherapeutics will be responsible for conducting the necessary trials to bring EIDD-2801 to licensure.

"As a potent oral antiviral agent, EIDD-2801 represents one of the best options available to impact the current global pandemic. Its broad-spectrum antiviral activity makes it an excellent candidate for treating a variety of infectious diseases including influenza as well as for other emerging infectious diseases like Eastern Equine Encephalitis," says Wendy Holman, CEO of Ridgeback Biotherapeutics.

"During this unprecedented crisis, Ridgeback looks forward to working with the seasoned drug development team at DRIVE and the dedicated and brave medical, public health and governmental personnel that are on the frontlines of this pandemic – both within the United States and abroad,” Holman says. “The ability to deliver promising treatments to patients in need is what makes us excited to come to work every day. Ridgeback is uniquely positioned to help advance EIDD-2801 not only for its potential commercial indications, but also for the treatment of diseases that are critical to global health."

The development of EIDD-2801 has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), under contract numbers HHSN272201500008C and 75N93019C00058, and from the Defense Threat Reduction Agency (DTRA), under contract numbers HDTRA1-13-C-0072 and HDTRA1-15-C-0075, for the treatment of Influenza, coronavirus, chikungunya, and Venezuelan Equine Encephalitis Virus.