Oral Drug Tested at Georgia State Recommended for Emergency Use Authorization to Treat COVID-19

ATLANTA—A new antiviral drug, MK-4482/EIDD-2801 or molnupiravir, that was tested in the Institute for Biomedical Sciences at Georgia State University against influenza virus and SARS-CoV-2 has been recommended for emergency use authorization to treat COVID-19 in the United States by pharmaceutical companies that completed a Phase 3 clinical trial and achieved promising results.

Merck and Ridgeback Biotherapeutics, which collaborated on the Phase 3 study, have reported the investigational oral drug reduced the risk of hospitalization or death by about 50 percent in patients with mild or moderate COVID-19 compared to those who received a placebo. Merck plans to seek emergency use authorization in the U.S. from the U.S. Food and Drug Administration as soon as possible and plans to submit applications to regulatory agencies worldwide. Molnupiravir could become the first oral antiviral medicine to treat COVID-19.

Dr. Richard Plemper, Distinguished University Professor and director of the Center for Translational Antiviral Research at Georgia State, is the principal investigator of a $5 million partnerships grant from the National Institutes of Health to explore use of EIDD-2801 against influenza. Together with Drug Innovations at Emory (DRIVE) CEO Dr. George Painter, he reported activity of EIDD-2801 against pandemic influenza in the journal Science Translational Medicine before the onset of the COVID-19 pandemic.

Quickly redirecting research in the pandemic to SARS-CoV-2, Plemper’s group subsequently published in the journal Nature Microbiology the first demonstration that molnupiravir is orally active against SARS-CoV-2 in an animal model and established proof-of-concept that treatment completely suppresses virus transmission to untreated contacts within 24 hours.

At the time of publication of the Nature Microbiology study, Plemper accurately predicted that “this first demonstration of an orally available drug to mitigate infection and rapidly block SARS-CoV-2 transmission could be game-changing.” Plemper’s team used a ferret model of SARS-CoV-2 infection for their work, which they consider highly relevant since “ferrets readily spread SARS-CoV-2, but mostly do not develop severe disease, closely resembling SARS-CoV-2 spread in young adults.”

Plemper’s group anticipates that if their ferret-based transmission data translate to humans, COVID-19 patients treated with molnupiravir could become non-infectious within 24 hours after the beginning of treatment.

Co-authors of the Nature Microbiology study include R.M. Cox, J.D. Wolf and R.K. Plemper at Georgia State. Georgia State’s Department of Animal Resources and high containment laboratory staff supported this work.

The study was funded by public health service grant AI141222 from the National Institutes of Health/National Institute of Allergy and Infectious Diseases to Georgia State University.

To read the studies, visit

https://www.science.org/doi/epdf/10.1126/scitranslmed.aax5866

and

https://www.nature.com/articles/s41564-020-00835-2.

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