Merck and its partner Ridgeback Biotherapeutics recently announced that its new pill to treat COVID-19 reduces the risk of hospitalization and death in patients with mild to moderate COVID-19 by approximately 50 per cent.
After the experimental oral antiviral treatment showed “compelling results” during late-stage clinical trials, the pharmaceutical company announced its plan to apply for emergency FDA approval of the drug, which, if approved, would authorize the use of the first oral antiviral for COVID-19. The drug could be available by the end of this year following regulatory authorization.
The pill, called molnupiravir, is designed to impede viral replication by inserting errors into the virus’s genetic code. During Phase 3 trials of the drug, 7 per cent of volunteers in the group that received the medication within five days of COVID-19 symptoms were hospitalized with no deaths reported, while 14 per cent of the group receiving the placebo were hospitalized or died, effectively cutting the risk of hospitalization or death in half. However, all participants in the trial were unvaccinated and had an underlying health condition or factor that placed them at a higher risk of developing a severe case of COVID-19.
The pills are to be administered as soon as possible to individuals exhibiting symptoms related to COVID-19 but are not yet in the hospital, a critical period in which the virus is undergoing a rapid replication period. Research suggests that the drug should be taken as early as possible to increase effectiveness.
Although Merck has published the results of its Phase 3 trials in a press release, a peer-reviewed medical journal has yet to be published. While the trials involved unvaccinated participants, FDA regulators are likely to consider authorizing the oral antiviral for broader use amongst vaccinated patients exhibiting symptoms of COVID-19. Additionally, although the efficacy rate of molnupiravir is lower than monoclonal antibody (mAb) treatment, Merck’s pill will likely have the potential to reach a broader population than mAb treatment.
Merck is a leader amongst other pharmaceutical companies seeking to develop oral antivirals, including Atea Pharmaceuticals, Pfizer, and Roche. Although clinical trials for similar treatments are underway, results from these trials are yet to be published, and the treatments are unlikely to be available for use until mid-2022.
As COVID-19 continues to wreak havoc across healthcare systems around the globe, Merck’s pill and similar treatments are a welcome development to continue the fight against COVID-19.