Merck announced on Friday that a recent study shows that its experimental coronavirus drug, molnupiravir, reduces the risk of serious illness and death in people diagnosed with COVID-19 by at least 50%.
Merck and its partner, Ridgeback Biotherapeutics, plan to seek emergency use authorization for the treatment as soon as possible, Reuters reported.
If approved, the drug — which is believed to be effective against all variants of the coronavirus, including the highly contagious Delta variant — would be the first oral antiviral medication to treat COVID-19.
At the time of this reporting, all current COVID-19 therapies authorized for use in the U.S. require administration via IV or injection.
What are the details?
The company announced that its interim clinical trial results were very positive and noted that the drug works by introducing "errors" into COVID-19's genetic coding.
The study enrolled patients around the world with mild to moderate COVID-19 and who had at least one risk factor associated with serious illness or death. The patients received a dose of the drug every 12 hours for five days.
The Reuters report noted that an interim analysis of 775 patients in the study determined that 7.3% of those given molnupiravir "were either hospitalized or had died by 29 days after treatment" when compared with 14.1% of placebo patients. There were zero deaths in the molnupiravir group and eight deaths in the placebo patients.
The outlet reported that the data shows that the drug is "not capable of inducing genetic changes in human cells," though it warned male patients in the trial to abstain from heterosexual intercourse or agree to use contraception. Female participants of childbearing age were not permitted to be pregnant and also were told to use contraception.
Robert Davis, Merck's CEO, told Reuters, "This is going to change the dialogue around how to manage COVID-19."
Wendy Holman, Ridgeback's CEO, added, "Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed."
The biopharmaceutical company says it plans to produce 10 million courses of the treatment by the end of the year, and has a U.S. government contract to supply 1.7 million courses of the drug at $700 per course.
Company officials are not certain how long an approval from the Food and Drug Administration will take.
"I believe that they are going to try to work with alacrity on this," said Dean Li, head of Merck's research labs.
"[The drug] exceeded what I thought the drug might be able to do in this clinical trial," Li added,. "When you see a 50% reduction in hospitalization or death that's a substantial clinical impact."