Last week, pharmaceutical companies Merck and Ridgeback Biotherapeutics LP announced the yet-to-be peer-reviewed Phase III trial interim results for molnupiravir, an antiviral pill that shows some exciting potential as a COVID-19 treatment, preventing people from becoming more severely ill.
The treatment approach in the trial had patients taking the pills over the course of five days. After 29 days, 7.3 percent of the patients that took molnupiravir were hospitalized, compared to 14.1 in the placebo arm of the trial. No deaths were reported in the former, while eight deaths were reported in the control group. The data suggests that the pill cuts the risk of hospitalization or death by 50 percent.
There were 385 participants that received molnupiravir, and 377 that received the placebo. The patients were selected due to having lab-confirmed mild-to-moderate COVID-19, plus at least one risk factor associated with poor disease outcomes such as older age, heart disease, diabetes, or obesity.
The pill is not a replacement for vaccines – they remain the most effective way to protect oneself against COVID-19 – but they could work as an alternative to treatments such as remdesivir and monoclonal antibodies. These need to be administered intravenously, usually in a professional medical setting. Molnupiravir is easier to administer, being an oral pill, and it costs up to one-third of them.
Side effects appeared to be rare, but were more pronounced on the placebo side. While the numbers in the Phase III trial were not huge, the positive results had the companies stopping the trial on the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA).
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, said in a statement.
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”
The pharmaceutical company plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these interim results, as well as to other regulatory bodies worldwide.