An oral antiviral pill developed by pharmaceutical giant Merck and Florida startup Ridgeback Biotherapeutics could cut the risk of hospitalization and death from COVID-19 by half, the two companies said on Friday, reporting the results of a phase. 3 study of the experimental drug.
The pill, called molnupiravir, is helping to halve hospitalization in COVID-19 patients with mild to moderate symptoms after a month, according to an interim analysis of a phase 3 study. Of the nearly 800 trial participants recruited worldwide before August 5, 7.3 percent of those who received molnupiravir were hospitalized through Day 29, compared with 14.1 percent of placebo-treated patients who were hospitalized or died.
“Up to Day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo,” Merck and Biotherapeutics reported in a joint press release.
Merck and Biotherapeutics said they plan to submit the drug for FDA emergency use authorization as soon as possible and will seek regulatory approval worldwide. If approved, molnupiravir will be the world’s first oral COVID-19 drug intended for widespread use. Another antiviral oral drug, remdesivir, is FDA-approved for the treatment of COVID-19. But it is only intended for use in hospitalized patients.
Molnupiravir works by interfering with an enzyme that COVID-19 uses to copy its genetic code and reproduce itself. The pill has shown a similar effect against other viruses.
“Molnupiravir is a nucleoside analogue, a type of antiviral agent that has been effective against other viruses. So the mechanism here makes sense,” said Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, in a tweet on Friday.
Merck originally planned to recruit 1,550 people for the Phase 3 study. But an independent committee, in consultation with the FDA, advised Merck to stop enrolling after seeing the positive interim results. “A group of independent experts saw the data and said ‘we’ve seen enough’ and stopped the trial because the drug was clearly working. That is an important verification.” said Dr Jha.
Although molnupiravir is not a vaccine, public health experts are hopeful that it will help contain the spread of the coronavirus by treating infections at an early stage.
“As the virus continues to circulate widely, and because currently available therapeutic options are administered and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of hospital are critical. Ridgeback CEO Wendy Holman said in a statement.
“With these compelling results, we are optimistic that molnupiravir could become an important drug as part of the global effort to fight the pandemic,” added Merck CEO and President Robert M. Davis.
The US government has pledged to buy 1.7 million doses of the drug if approved by the FDA. Regardless of when an FDA EUA arrives, Merck says it plans to produce 10 million courses of treatment by the end of 2021, with more doses expected in 2022.
Other drug makers, including Pfizer and Roche, are experimental similar oral COVID-19 treatments and could report results in the coming months.