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.
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 US, 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.
Results from this upcoming AGILE study, as well as two previously initiated Phase 2 studies in the US, will provide valuable information as Merck, in collaboration with Ridgeback, plans further clinical trials in patients with COVID-19.
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 (NYSE: MRK).
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.
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
GSK's meningitis vaccine candidate accepted for FDA review
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
AbbVie announces interim evaluation of Atogepant Phase three, open-label 156-week extension study