Most of the efforts to create treatments for COVID-19 focus on hospitalized patients—and with good reason. After all, they are the sickest patients with the worst prognoses. Ridgeback Biotherapeutics is doing something different.
The Miami-based biotech is kicking off two phase 2 trials of its antiviral treatment, EIDD-2801: the first in hospitalized COVID-19 patients and the second in patients newly diagnosed with COVID-19 who are still at home. Both trials will pit a twice-daily dose of EIDD-2801 against placebo over five days to see whether the drug can clear the virus more quickly than placebo.
“The goal of these studies is to explore the ability of EIDD-2801 to rapidly eliminate the SARS-CoV2 virus,” said Wayne Holman, co-founder and scientific adviser of Ridgeback Biotherapeutics, in a statement. If the candidate can beat back the virus more quickly than placebo, it could stop the disease in its early stages and “potentially reduce the time during which patients are infectious to others and change the course of the pandemic,” he added.
EIDD-2801 is an oral nucleoside analog that has shown broad-spectrum activity against RNA viruses, including influenza and coronaviruses like SARS and MERS. Ridgeback licensed the pill in March from Emory University’s nonprofit biotech company, Drug Innovations at Emory, or DRIVE. At the time, DRIVE was prepping it for clinical trials in influenza, but it “immediately recognized” its potential for treating COVID-19.
Though the COVID-19 studies are just beginning, Ridgeback is gearing up for a rollout if all goes to plan. It has been manufacturing hundreds of thousands of doses of the drug, with plans to ramp that up to millions of doses by the fall.
“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,” said Wendy Holman, Ridgeback co-founder and CEO, in the statement.
Last month, Ridgeback signed a development and commercialization deal with Merck under which the Big Pharma, through a subsidiary, will pick up the worldwide rights to EIDD-2801 and related molecules. Merck will be on the hook for clinical development, regulatory filings and manufacturing, but Ridgeback is advancing the drug on its own pending regulatory clearance of the deal, Financial Times reported.