Merck’s recent announcement about Molnupiravir indicates the possible imminence of an orally administered antiviral medication targeting COVID-19. The market for this drug class is substantial, given that about 90% of COVID-19 patients fall in the mild-to-moderate category. The Merck clinical research was made possible by academic medical center-based trial sites such as UNC-Chapel Hill, which commenced working on Molnupiravir in 2016.
As TrialSite has chronicled, the drug was originally discovered by a group in Emory University to fight off serious influenza. The drug’s intellectual property is controlled by a group called DRIVE, part of Emory University, which founded the group—combining three seasoned leaders with over $20 million in foundational funding to build a world-class infrastructure for developing drugs.
However, original animal testing for the drug, part of what is known as preclinical research, took place at UNC Gilling’s School of Global Public Health, Vanderbilt, and Emory University, where the team demonstrated that the drug blocked SARS-CoV-2 transmission while also apparently mitigating lung damage.
Further studies using human lung cells at UNC School of Medicine also showed the drug’s ability to inhibit SARS-CoV-2. These studies were led by virologist Timothy Sheahan at UNC Gilling’s School of Global Public Health and pioneering antiviral drug research guru Ralph Baric—the latter associated with his share of controversy with involvement in what some consider coronavirus-focused gain-of-function research back in 2015.
The First Trial Site
William A. Fischer II, associate professor of pulmonology and critical care at UNC School of Medicine and director of emerging pathogens at UNC Institute for Global Health and Infectious Diseases, called the recent news “…a real game changer for a pandemic like COVID-19 because it allows us to treat people quicker and with a method that’s convenient and accessible.”
Fischer led a Phase 2 clinical trial sponsored by both Merck and the original licensee of the drug, Ridgeback Biotherapeutics that established the foundation for the pivotal Phase 3 trial now recently halted due to the findings. If the U.S. Food and Drug Administration (FDA) provides a greenlight, the drug could be available before the end of the year at a cost of $700 per course for the first federal procurement.
UNC-Chapel Hill study results revealed that after five days, investigator tests of subjects in the Molnupiravir arm couldn’t detect any virus after the twice a day regimen.
Timothy Sheahan, Kenan Distinguished Professor of Epidemiology, led a pivotal study of the broad-spectrum antiviral. Professor Sheahan declared recently, “We were the first to show it worked against lots of different coronaviruses in cells and culture and animal models of coronavirus disease,” Sheahan said. “The work that we did at Gillings School of Global Public Health demonstrated that Molnupiravir was effective at stopping all the coronaviruses we tested in the lab including SARS-CoV-2, the virus that causes COVID-19, common cold-causing coronaviruses and emerging coronaviruses like SARS, and MERS.”
Kudos to UNC-Chapel Hill
While TrialSite suggests the antics of Merck against positive ivermectin study results are completely unacceptable, we also celebrate the momentum of any safe and effective treatments targeting COVID-19. TrialSite has been on the record that what is needed to overcome the pandemic is a range of medical and public health tools from a flu-shot like treatment (think what they call “vaccines” today) to antivirals ranging from generic and economical to branded and more expensive and smart public health decisions.
TrialSite notes that UNC Chapel-Hill was instrumental in identifying remdesivir as a possible treatment targeting COVID-19. UNC Chapel-Hill clearly has established itself as one of the global elite of antiviral research centers.
Timothy Sheahan, Ph.D., UNC Gilling’s School of Global Public Health
William A. Fischer II, MD, associate professor of pulmonology and critical care at UNC School of Medicine as well as director of emerging pathogens at UNC Institute for Global Health and Infectious Diseases