Emory University researchers have helped develop an oral antiviral drug that could treat COVID-19, a potential breakthrough in the ongoing pandemic.
Merck and Ridgeback Biotherapeutics announced Friday they plan to seek emergency use authorization from federal health officials for the drug, molnupiravir, after research showed “compelling” results in clinical trials. If approved, it would be the first pill for COVID-19.
Molnupiravir was developed several years ago by Drug Innovation Ventures at Emory DRIVE, LLC, a nonprofit owned by Emory, to battle a broad spectrum of viruses and has shown strong results in animal testing against influenza. The Emory team thought it could be used to treat COVID-19. The drug, known to some as EIDD-2801, was licensed to Ridgeback, which later licensed it to Merck, Emory officials said.
“Our goal when we started DRIVE was to discover antiviral agents for influenza and emerging diseases,” DRIVE’s CEO and co-founder, George Painter, said on Emory’s website. “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.”
Molnupiravir works by preventing COVID-19 from replicating inside the body. A few other treatments, such as remdesivir, have received emergency use authorization from the FDA, but they must be injected intravenously.
The multi-site study tracked non-hospitalized adult patients with mild to moderate COVID-19 and who were considered higher risk due to health problems such as obesity, diabetes or heart disease. Most of the cases evaluated in the trial were patients with the highly contagious delta variant and other COVID-19 variants.
Merck released information Friday in a press release that showed molnupiravir reduced the risk of hospitalization or death by roughly 50%. After nearly a month, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received a placebo, researchers said.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,” Robert M. Davis, Merck’s chief executive officer and president.
The news is potentially a positive development, as COVID-19 has killed more than 20,000 Georgians and sickened hundreds of thousands more. A recent surge was fueled by the delta variant combined with the state’s low vaccination rate, experts say.
Merck’s interim data analysis was based on 775 patients. Recruitment for the study was stopped because researchers were so pleased with the initial results.
Several local physicians said the information released by Merck suggests the drug could be a promising treatment against COVID-19.
Dr. Neha Paranjape, an infectious disease specialist at Wellstar Kennestone Hospital, said the findings were “fairly impressive,” but she wants to see more data.
Dr. Thomas Bat, chief executive officer of North Atlanta Primary Care, which has 16 clinics throughout metro Atlanta, has a degree in microbiology and has been paying close attention to the research on molnupiravir. Bat said the drug confuses the virus and blocks it from replicating, like some flu and HIV antiviral medications. He’s hopeful the drug can be approved by Thanksgiving, when flu cases increase, and around the time there was a rise in COVID-19 cases last year nationwide.
Merck previously agreed to supply approximately 1.7 million courses of molnupiravir, upon emergency use authorization approval.
Officials at Emory, which got FDA approval in April 2020 to begin human clinical trials for the drug, are excited about the findings. Georgia State University was also involved in the research.
“Critical to our mission at Emory is ensuring that scientific discoveries can become real-world solutions that improve the health of our global population and save lives,” said Jonathan Lewin, Emory’s executive vice president for health affairs and executive director of its Woodruff Health Sciences Center. “As public health concerns mount in the wake of this pandemic, Emory is uniquely positioned because of our significant experience developing successful therapeutics for HIV, Hepatitis C and Hepatitis B, and we will continue to use that expertise to focus on unmet viral diseases of global concern.”
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