By Adriana Rodriguez, Contributing Writer
Merck, or MSD as it is commonly known outside of the United States and Canada, is a research-intensive pharmaceutical company that has recently collaborated with Ridgeback Biotherapeutics, a biotechnological company, that focuses on emerging infectious diseases. Together, they have developed Molnopiravir (MK-4482/EIDD-2801). Molnopiravir is an orally administered antiviral medication that has proven to reduce the risk of hospitalization and/or deaths by 50 percent in a planned interim analysis according to the official website www.merck.com.
The pill disrupts the ability of SARS-CoV-2, the causative agent of COVID-19, to copy its genetic code and reproduce. The medicine was first invented at Drug Innovations at Emory (DRIVE) University, LLC, a nonprofit biotechnological company owned by Emory University. It was then further developed by Merck and Co., Inc. in collaboration with Ridgeback Biotherapeutics with the understanding that all profits were to be shared equally between the two companies.
Molnopiravir was part of the MOVe-OUT trial (MK-4482-002) which was a Phase III globally randomized, placebo-controlled, double-blind, multi-site study. The study’s primary objective was to evaluate the efficacy of Molnopiravir by comparing the number of participants who were hospitalized and/or died in comparison to previous studies involving the usage of placebos from the time of randomization to day 29 in the analysis. The study began with 775 patients prior to Aug. 5, 2021, and required all participants to be unvaccinated, have laboratory-confirmed mild-to-moderate COVID-19 with onset symptoms within five days of the study randomization, and a minimum of one risk factor associated with poor disease outcome at their entry to the study.
The research concluded that Molnopiravir greatly reduced the severeness of the virus, with only 7.3 percent of the patients who received it being hospitalized in contrast to the placebos’ 14.1 percent. In addition, none of those who ingested the pill died while eight of those who had received a placebo had. The efficacy of the pill also proved to be unaffected by the timing of the onset symptoms or of the underlying risk factors. The efficacy of the pill remained consistent even with the introduction to variants of the virus such as Gamma, Delta, and Mu.
Due to such promising results, the study completely stopped recruitment even of it was already approaching its Phase III sample size of 1550, with more than 90 percent of this intended sample size already enrolled.
Although the pill is still being investigated for post-exposure prophylaxis in the MOVe-AHEAD study, Merck and Co. plans to submit an application for Emergency Use Authorization (EUA) to the U.S. Food and Drugs Administration (FDA).
The FDA’s decision could come within weeks of application submission and if authorized, Molnopiravir would be the first pill to gain regulatory approval to treat COVID-19 as declared in www.usnews.com.
The www.apnews.com website explains how this pill would greatly ease the pressure on hospitals seeing as all authorized medications in the United States currently require the usage of IV or injections.
It could also aid in the treatment of the virus in poor areas with little to no access to hospitals. As someone who was not involved in the research, Dr. William Schaffner, an infectious disease expert at Vanderbilt University, proclaims that it would be more efficient while less expensive in his interview with U.S. News.
Although beneficial, medical experts like Jeff Zients, White House Coronavirus Coordinator, stress the importance of vaccines as a preventive method instead of just a treatment. Zients ascertains that the government will continue to have vaccination as its main strategy for the control of the pandemic.
Andrew Pekosz, a virologist specialist, agrees by declaring that antiviral drugs are not replacements for vaccination. He argues that both strategies of disease control should be used at the same time.
The Merck Antiviral Pill faces common risks and uncertainties like manufacturing difficulties, pharmaceutical industry regulations, and healthcare legislation. It is expected to become a prescribed medicine with a test-and-treat method.
