Molnupiravir, an investigational oral antiviral drug that was discovered by researchers at Emory University, appears to significantly reduce the risk of hospitalization or death in patients with mild to moderate COVID-19, according to interim data from a Phase 3 study.
Formerly known as EIDD-2801, molnupiravir can be provided as a pill in an outpatient setting which could ease up distribution across the world. Although remdesivir and antiviral monoclonal antibodies have received EUAs from the FDA, they must be infused intravenously. Molnupiravir works by targeting an enzyme needed for the virus to make copies of itself and introducing errors in the viral genome.
When the COVID-19 pandemic began, Drug Innovation Ventures at Emory (DRIVE) repurposed a broad-spectrum antiviral drug it had been developing for infectious diseases. DRIVE’s CEO and co-founder, George Painter, PhD, had invested nearly five years of research with funding from the National Institutes of Health into the antiviral compound EIDD-2801 for influenza; he and his colleagues soon realized the drug could likely help in treating COVID-19 patients, too.
“Our goal when we started DRIVE was to discover antiviral agents for influenza and emerging diseases,” Painter says. “We were able to quickly redirect our research to COVID-19 because we were already working on highly pathogenic coronaviruses. Without a doubt, deploying easy-to-use antivirals will be an important piece of the larger puzzle of solving this and future pandemics.”
The analysis of molnupiravir was conducted by Merck and Ridgeback Biotherapeutics, which are currently developing the drug after licensing it from DRIVE.
Merck says it plans to apply for Emergency Use Authorization (EUA) to the U.S. Food & Drug Administration (FDA) “as soon as possible based on the findings.” If authorized, Molnupiravir could be the first antiviral pill for COVID-19.
Merck’s interim data analysis was based on 775 patients. The findings suggest that the drug reduced the risk of hospitalization or death by approximately 50% among adult patients with mild to moderate infection; around 7% of patients who received molnupiravir were either hospitalized or died through Day 29 compared with 14% of placebo-treated patients. During the study period, no deaths were reported in patients who received molnupiravir as compared to eight deaths in patients who received placebo.
Based on the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, Merck says recruitment into the study “is being stopped early due to these positive results.”
Merck’s interim data was based on randomized, placebo-controlled, double-blind trials that were conducted globally across more than 170 sites. For more information about the study, visit clinicaltrials.gov.