We first heard about EIDD-2801 in May, 2020. One of the researchers, Dr. Ralph Baric, was a guest on our syndicated public radio show. Dr. Baric has been studying coronaviruses for more than 35 years and was hot on the trail of drugs to combat this class of pathogens. On April 29, 2020, Baric and his colleagues published a study in Science Translational Medicine that described NHC/EIDD-2801. That was the early name for molnupiravir, one of the first oral drugs with antiviral activity against SARS-CoV-2.
The findings of the mouse trial were encouraging:
“The potency of NHC/EIDD-2801 against multiple CoVs [coronaviruses] and oral bioavailability highlights its potential utility as an effective antiviral against SARS-CoV-2 and other future zoonotic CoVs.”
Ever since we read that initial study we have been interested in this drug. The results in humans are now in!
Fast Forward to October 1, 2021:
Today, the Merck company, together with Ridgeback Biotherapeutics, the company that originally developed molnupiravir, announced the results from a clinical trial. Independent experts monitoring the trial recommended it be stopped early because the results were so clear.
Molnupiravir cuts the risk for serious COVID-19 infection and hospitalization by about 50%. In this clinical trial, 775 unvaccinated people with confirmed cases of COVID-19 took either molnupiravir or a look-alike placebo pill. All of these volunteers had pre-existing conditions putting them at high risk for severe disease. In other words, they were obese or elderly. They started taking the medicine within five days of initial symptoms.
None of the people taking the drug died, but eight individuals in the placebo arm did. About 7 percent of those getting molnupiravir were hospitalized. Twice that many taking placebo pills were hospitalized or died. The safety monitors thought that made it unethical to continue the trial with people on placebo.
Laboratory research indicates that the drug is equally active against delta, gamma and other variants of SARS-CoV-2. Some scientists speculate it might even help protect people from other coronaviruses.
Emergency Use Authorization (EUA) for Molnupiravir?
Merck and Ridgeback will be submitting the data and an application for emergency use application to the FDA. That is the same process that has been used for vaccines and the monoclonal antibodies. That puts it on an ultra-fast track for patient access.
The drug company has already started making pills. That’s a pretty clear indication that 1) Merck believes the medication is effective and 2) the FDA will grant EUA. The US government has already committed over $1 billion for the first pills that come off the production line.
If the FDA Grants Molnupiravir Emergency Use, What’s Next?
We don’t want to get out over our skis on this medication, but the results could be dramatic. For one thing, people who are vaccine hesitant might be willing to take molnupiravir. It could also be distributed world wide in relatively short order. Indian drug manufacturers are already gearing up production.
To be maximally effective, most antiviral medications need to be taken at the very first sign of infection. That’s how antiviral drugs like Tamiflu (oseltamivir) work against influenza. If someone is exposed to the coronavirus, molnupiravir might be used preventively but research has not yet demonstrated such a tactic.
We have not yet seen the data about side effects with molnupiravir, so we don’t know how well people will tolerate this new medicine. Nonetheless, an oral drug against COVID-19 that is taken at home could be a real step forward in managing this pandemic.