Pharmaceutical giant Merck & Co
The drug, called molnupiravir, is administered orally and is designed to inhibit the replication of the coronavirus inside the body after infection. The companies plan to seek emergency authorization from the Food and Drug Administration, as well as marketing applications to international regulators, as soon as possible.
In the global study, all 775 unvaccinated trial participants had laboratory-confirmed symptomatic COVID infection, and were randomly assigned molnupiravir or an inert placebo within five days of symptom onset. Every participant also had at least one underlying health condition that put them at greater risk of developing severe disease, with the most common risk factors including obesity, diabetes, heart disease, and being above the age of 60 years.
Interim analysis of the pair's Phase 3 clinical trial found that 7.3% of participants--all of which had mild or moderate COVID infection--treated with the antiviral were hospitalized within 29 days and no deaths were recorded. Compared to the placebo group, 14.1% were were hospitalized or succumbed to their infections by day 29, with eight reported deaths.
"More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world," said Merck CEO Robert Davis in a press statement. "With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck's unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most."
Moreover, the antiviral's efficacy was not affected by the timing of symptom onset or participants' underlying health conditions, the data showed. Molnupiravir also proved to be effective in treating all common variants of COVID, including the highly transmissible Delta variant.
The treatment was also well tolerated between both trial groups, with 1.3% of participants in the balapiravir group discontinuing use due to an adverse side effect, compared to less than 3.4% in the placebo group.
Merck is also testing molnupiravir in a separate global Phase 3 clinical trial to evaluate its efficacy in preventing the spread of COVID within households.
"The news of the efficacy of this particular antiviral is obviously very good news," White House chief medical advisor Dr. Anthony Fauci said during a COVID briefing Friday. "The company, when they briefed us last night, had mentioned that they will be submitting their data to the FDA imminently."
"The FDA will look at the data and in their usual, very efficient and effective way, will examine the data as quickly as they possibly can, and then it will be taken from there," Fauci added.
If authorized, molnupiravir could be the first COVID antiviral treatment that is administered orally. Current COVID antivirals, such as Gilead Sciences'
Merck expects to produce 10 million courses of the treatment by the end of the year. The company had agreed earlier this year to supply the United States with about 1.7 million doses of the antiviral upon FDA authorization or approval.
