A new antiviral medication was found to reduce the likelihood that COVID-19 patients will end up in hospital or die. This was announced by Merck on Friday (Oct.
According to Stat News, the drug, molnupiravir was developed by Merck and Ridgeback Biotherapeutics. It could be the first approved oral medication for COVID-19 treatment, if the U.S. Food and Drug Administration (FDA), authorizes its use. However, the data from the trial have not yet been peer-reviewed so its safety and effectiveness need to be confirmed.
According to a Sept. 13 report in Nature Structural & Molecular Biology, the pill introduces mutations to the coronavirus's genetic material or RNA. This causes the virus to try to replicate itself. The drug mimics an active form of RNA inside the body and inserts itself into the growing sequence. This antiviral mechanism is quite unusual. Therefore, safety data from the trial will be closely evaluated to determine if there are any unintended consequences, said Dr. Andy Pavia of the Division of Pediatric Infectious Diseases, University of Utah.
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In the Merck statement, Wendy Holman, chief executive of Ridgeback Biotherapeutics stated that the virus is still widely circulated and that therapeutic options are not available. Therefore, it is critical to find antiviral treatments at home for people with COVID-19.
The trial involved 775 adults with moderate-to-moderate COVID-19. Each participant had at least one risk factor that could lead to poor COVID-19 outcomes such as heart disease or diabetes. Merck reported that participants were randomly allocated to either a five day course of molnupiravir, or a placebo pill within five days of developing symptoms. Over the course of five days, participants took two pills per day.
After 29 days, 53 patients in the placebo group, or 14.1%, were admitted to hospital or died from COVID-19. Only 28 patients, or 7.3%, who were treated with molnupiravir were admitted to the hospital. No deaths were reported.
Stat News reported that although the Merck statement did not provide any information on side effects, it stated that there was a similar rate of adverse events between the treatment and placebo groups. In particular, 35% of people who received molnupiravir, and 40% of those who were given a placebo had an adverse event. 1.3% of molnupiravir-treated patients stopped taking the pill because of these side effects, compared to 3.4% who stopped taking it.
According to the company, it is unclear if these adverse reactions were caused by the pills or merely symptoms of COVID-19. Dean Li, Merck's head for research and development, stated to Stat News that while no side effect was found with molnupiravir in an initial assessment, Stat News will have more information in the future.
A Merck statement stated that the FDA and an independent Data Monitoring Committee advised drugmakers not to recruit new patients to the trial.
"The fact that the Data and Safety Monitoring Board stopped the new clinical trial early due to overwhelming efficacy, deeming the proceeding unethical, would be considered an Eureka moment" Dr. Eric Topol, a Scripps Research professor of molecular medicine, tweeted.
According to a company statement, Ridgeback Biotherapeutics and Merck plan to apply for an Emergency Use Authorization (EUA), to the FDA "as quickly as possible" and also to seek clearance from regulatory bodies elsewhere in the world. Merck claimed it can produce 10,000,000 courses of molnupiravir before the end of 2021. In June, the U.S. government bought 1.7 million courses.
Stat News has more information about the Molnupiravir Trial.
Original publication on Live Science
