Trial to be Conducted with the University of Liverpool, Liverpool School of Tropical Medicine & Southampton Clinical Trials Unit
MIAMI–(BUSINESS WIRE)–Ridgeback Biotherapeutics announces the start of enrollment in a Phase 2 trial of potential COVID-19 treatment EIDD-2801. The new trial will be conducted using the new COVID-19 drug testing platform AGILE, which was developed by The University of Liverpool, Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit. AGILE will test multiple potential therapeutics, and EIDD-2801 was selected to be the first oral anti-viral to be studied in the AGILE platform.
“Ridgeback is proud to work with Professor Saye Khoo, Chief Investigator on AGILE at the University of Liverpool and his team to design the EIDD-2801 specific protocol,” said Wendy Holman, co-founder and CEO of Ridgeback Biotherapeutics. “It was a tremendous trans-continental effort to bring EIDD-2801 into a Phase 2 efficacy protocol to benefit COVID-19 patients in the U.K. immediately following Phase 1. Ridgeback is especially appreciative of the rapid and intensive input and guidance from MHRA throughout this process.”
Due to COVID-19, many Phase 1 sites were closed to all activity and others were limited to only test COVID-19 related therapeutics during March, April and May. Through April and May, Ridgeback was able to conduct stream-lined Phase 1 trials, condensing 12 to 18 months of work into just two months. This accelerated development was made possible because of the dedicated efforts of the Ridgeback team, FDA, MHRA and Ridgeback’s CRO, Covance.
Ridgeback’s accelerated Phase 1 trials ensure that tests of EIDD-2801 will not be delayed now that Phase 1 sites are reopening across the U.S., allowing medicines for other therapeutic areas to be trialed.
Ridgeback announced last week the closing of its collaboration agreement with Merck, known as MSD outside the United States and Canada. (Read more…) Results from this upcoming AGILE study, as well as two previously initiated Phase 2 studies in the U.S., will provide valuable information as Merck, in collaboration with Ridgeback, plans further clinical trials in patients with COVID-19. Ridgeback and Merck are committed to making the medicine accessible and affordable globally.
EIDD-2801 is an investigational, orally-bioavailable form of a 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-CoV-1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and our partner Merck.
About Ridgeback Biotherapeutics
Ridgeback Biotherapeutics was co-founded by CEO Wendy Holman and Dr. Wayne Holman, a scientific advisor to the company, with a focus on developing anti-viral medications for diseases that have epidemic and pandemic risk. Ridgeback Biotherapeutics is a majority woman-owned biotechnology company which is dedicated to finding life-saving and life-changing solutions for patients and diseases that need champions. 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. Ridgeback is in the process of completing a Biologics Licensing Application with the Food & Drug Administration for mAb114 (ansuvimab) for the treatment of Ebola, which received Breakthrough Therapy Designation in September 2019. 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 Numbers 75A50119C00059 and 75A50120C0009.