Emergency Use Authorization application submitted for COVID-19 antiviral discovered at Emory
Woodruff Health Sciences Center | Oct. 1, 2021
Formerly known as EIDD-2801, molnupiravir can be provided as a pill in an outpatient setting. Photo courtesy of Merck.
Update: On Oct. 11, Merck submitted an application for Emergency Use Authorization for molnupiravir to the FDA.
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.
The analysis was conducted by Merck and Ridgeback Biotherapeutics, which are currently developing the drug after licensing it from Drug Innovation Ventures at Emory (DRIVE).
In a press release Oct. 1, 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.
“Emory is pleased that our researchers invented molnupiravir. I applaud Dr. George Painter’s dedicated work in drug discovery and appreciate our partners who supported the development of molnupiravir, including the Defense Threat Reduction Agency, National Institutes of Health, Merck and Ridgeback,” says Gregory L. Fenves, president of Emory University. “As one of our nation’s leading research universities, the goal of serving humanity is infused into everything we do at Emory. George’s discovery is the latest example of the Emory mission in action and we will continue to invest in our researchers, scientists, and their groundbreaking work to benefit communities the world over.”
Congratulating the Emory researchers behind molnupiravir, Jonathan S. Lewin, Emory’s executive vice president for health affairs and executive director of Woodruff Health Sciences Center, says the news underscores the important role of academic medical 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,” Lewin says. “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.”
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.”
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, DRIVE quickly 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.”
DRIVE, a non-profit LLC wholly owned by Emory, effectively operates like an early-stage biotechnology company and focuses on the discovery and development of antiviral drugs for emerging infections, pandemic threats and biodefense.
Over the years, Emory has invested millions in foundational funding to build a world-class facility for developing drugs for viral diseases of global concern. Molnupiravir was the result of DRIVE leveraging some of this infrastructure. Many of these centers receive sizable federal grants, which fuels the research and development engine of these centers. Philanthropies and industry partners also support the enterprise. Academic research often serves to offset the prohibitive costs of discovery and enables pharmaceutical companies to pick therapies with the most promise and thereby reduce risk.
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.