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Ridgeback Biotherapeutics is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. (PRNewsfoto/Ridgeback Biotherapeutics LP)

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Ridgeback Biotherapeutics is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. (PRNewsfoto/Ridgeback Biotherapeutics LP)

ATLANTA and MIAMI, March 19, 2020 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, and Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, today announced a collaboration to rapidly advance DRIVEs EIDD-2801, a promising oral COVID-19 treatment, into human testing. This collaboration combines Ridgebacks unique experience advancing drug development efforts in the midst of an on-going disease outbreak with the three decades of experience that the DRIVE executive team has in antiviral drug development and commercialization.

Under the collaboration, Ridgeback has exclusively licensed DRIVEs 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 (DRC), Ridgeback Biotherapeutics licensed mAb114 (ansuvimab), a promising Ebola therapeutic, from NIAIDs 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 which was conducted during the 2018-2020 Ebola outbreak in the DRC. Results of that study were published in the New England Journal of Medicine in November 2019 (Mulangu, 2019). Currently, Ridgeback is completing its Biologics Licensing Application (BLA) submission with the U.S. Food and Drug Administration (FDA) for commercial licensure of ansuvimab (mAb114). 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. 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.

About 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-CoV2. In laboratory and animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), the bioactive form of EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung. EIDD-2801 is expected to begin clinical testing for SARS-CoV2 and influenza in the second quarter of 2020. In addition to activity against SARS-CoV2, EIDD-2801, in laboratory studies, has demonstrated activity against respiratory syncytial virus, influenza, chikungunya, Ebola, Venezuelan equine encephalitis virus, and Eastern equine encephalitis viruses.

About Ridgeback Biotherapeutics LP: Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman owned biotechnology company focused on orphan and infectious diseases. Initial funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals committed to investing in and supporting technologies that will make the world a better place. The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. Ridgeback is in the process of completing a Biologics Licensing Application with the Food & Drug Administration for mAb114 (ansuvimab) for the treatment of Ebola. Ansuvimab development has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00059.

About DRIVE: DRIVE is a non-profit LLC wholly owned by Emory and started as an innovative approach to drug development. Operating like an early stage biotechnology company, DRIVE applies focus and industry development expertise to efficiently translate discoveries to address viruses of global concern. DRIVEs mission is to discover and develop antiviral drugs for emerging infections, pandemic threats (e.g. COVID-19, swine flu, bird flu, dengue, chikungunya, Ebola, Zika, and viral encephalitis), and for biodefense. Because these diseases are major public health threats, antiviral drugs are critically needed to treat them; however, they are generally not profitable enough for industry to pursue, and thus are considered neglected diseases. DRIVE is unique in that it brings industry expertise to the assets of a leading research University to develop potential antiviral drugs to a de-risked value inflection point that substantially increases the probability of the potential drug being licensed by industry and developed for the ultimate benefit of the public. DRIVEs executive team, led by Dr. George Painter, has over three decades of drug development experience within both large pharmaceutical and biotechnology companies, including leading the development of multiple FDA approved antivirals to treat HIV and Influenza, among other viral diseases, including AZT and Relenza. Learn more at: http://driveinnovations.org/

About Defense Threat Reduction Agency: DTRA was founded in 1998 to integrate and focus the capabilities of the Department of Defense that address the Weapons of Mass Destruction (WMD) threat. The mission of DTRA is to safeguard America and its allies from WMD (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. Under DTRA, Department of Defense resources, expertise and capabilities are combined to ensure the United States remains ready and able to address the present and future WMD threats.

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Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment - Associated Press