US-based biotechnology company Ridgeback Biopharmaceuticals has initiated two Phase II clinical trials of EIDD-2801 for the treatment of Covid-19.
EIDD-2801 was invented by Drug Innovations at Emory (DRIVE) researchers at Emory University. Ridgeback licensed the programme in March this year.
Data from Phase I trials showed that the drug candidate is safe in human doses, which provide blood levels higher than that indicated by animal models to be effective against SARS-CoV-2.
Ridgeback Biopharmaceuticals co-founder and CEO Wendy Holman said: “While it is unclear if EIDD-2801 will have the intended efficacy that the Ridgeback team believes is possible, it is imperative to provide immediate and ample supply to the world should the clinical trials be successful.
“Phase I is the riskiest phase of drug development. Since the start of the pandemic the dedicated team at Ridgeback has worked 16 hour days, seven days a week to demonstrate that EIDD-2801 could achieve potentially therapeutic blood levels in humans with doses that were well tolerated.”
EIDD-2801 will be given to patients aged 18 years and above in two randomised, double-blind, placebo-controlled Phase II trials.
Study 2003 will enrol symptomatic, newly diagnosed patients at-home or out of hospital setting, while Study 2004 will enrol hospitalised patients. The studies are intended to assess the drug candidate’s efficacy.
Ridgeback Biotherapeutics co-founder and scientific advisor Dr Wayne Holman said: “If EIDD-2801 is able to eliminate the virus much more quickly than placebo we believe that will be the first indicator that EIDD-2801 could possibly change the course of disease in individual patients, halt the disease in the early stages, potentially reduce the time during which patients are infectious to others and change the course of the pandemic.”
The company intends to launch large-scale confirmatory studies of EIDD-2801 for the treatment of Covid-19 patients next month.