The first data from a large Phase III trial of an oral antiviral treatment for Covid-19 has been revealed, and interim results show the treatment reduces a person’s risk of hospitalisation or death from the virus by 50 per cent, when taken within five days of symptoms appearing. With the pandemic far from over, and talks of a booster/third dose of the vaccination in process, a pill for the virus is a positive sign to say the least.
Pharmaceutical company Merck’s oral Covid-19 drug is named molnupiravir. It had been in development for quite some time before the pandemic, as an antiviral agent targeting RNA viruses, with a primary focus on influenza. The drug was ready for initial human trials in late 2019, but when SARS-CoV-2 appeared all research focus shifted to whether molnupiravir would work against coronaviruses.
Pharma giant Merck stepped in in May 2020, and by October a large Phase 2/3 began, spanning over 20 countries. The trial was designed to find out if molnupiravir reduces the risk of hospitalisation or death in patients at high-risk of severe Covid-19. Patients in the trial were given a five-day course of the oral drug, beginning within five days of their symptoms initially appearing.
The drug was found to reduce rates of hospitalisation or death by 50 per cent compared to placebo. Only 28 out of the 385 patients taking molnupiravir ended up in hospital with Covid-19, compared to 53 of the 377 patients in the placebo group. More importantly, none of the hospitalised patients died, as compared to eight deaths in the placebo group.
Cellular microbiologist from the University of Reading, Simon Clarke says these results seem extremely promising. But as the full trial data is yet to be published it is unclear if this drug will be suitable for everyone. The interim data from Merck points out no adverse effects have been detected in the cohort trialled, however, Clarke says there is still plenty to learn about how this drug affects different people.
He said, “This drug works by causing the machinery that reproduces Covid-19’s genetic material to make mistakes, therefore stopping effective replication. That mode of action could cause problems with our own cells, and while reports are that the drug is well tolerated, we still don’t have full details of any side effects.” CEO of Merck, Robert Davis said he is confident the trial results are sound and says the company plans to submit an emergency use authorisation to the US Food and Drug Administration (FDA) very soon. The US government has already pre-ordered 1.7 million courses of the drug.
Davis said, “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. Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”