Merck, Ridgeback say their Covid-19 pill cuts hospitalization and death risks in half

A pill that can effectively prevent the worst consequences of covid-19 may finally be on its way.

On Friday, pharmaceutical companies Merck and Ridgeback Biotherapeutics announced preliminary results from a large trial testing their investigational antiviral drug, called molnupiravir. The drug is said to have reduced the risk of hospitalization or subsequent death by about 50% in high-risk people with mild to moderate illness – results so markedly positive that the trial was stopped prematurely. The companies are now planning to apply for an emergency use authorization for the drug, although the results have yet to be verified by outside scientists.

Molnupiravir is said to work by interfering with a virus’s ability to replicate inside a host’s cells, hopefully limiting the viral load and allowing the immune system to clear the infection further. quickly, without progressing to a more serious illness. The drug was in development before the pandemic as a potential treatment for influenza and other viral illnesses.

The randomized, double-blind, controlled phase 3 trial of molnupiravir, called MOVe-OUT, was intended to involve approximately 1,500 unvaccinated patients who initially had mild to moderate symptoms of covid-19 but were at risk. higher serious illness due to their pre-existing condition. health. As is common, however, the researchers performed an interim analysis of the trial when only 775 patients had been treated. About 14% of people on placebo were hospitalized or died within 30 days, compared to about 7% of those on molnupiravir. No deaths were reported in the treatment group, compared with eight people who died in the placebo group.

Clinical trials can be stopped prematurely by independent advice from outside scientists, because treatment seems so unlikely to work that it would be unethical to continue. But they can also be stopped because the treatment seems so much better than standard care that it would not be fair to continue to put participants in a control group or a placebo group. And that’s what the independent board agreed was the case here. The companies say more than 90% of the trial had already been recruited by the time it officially ended, however, there will likely be more data to sift through.

“With the virus continuing to circulate widely, and because currently available treatment options are infused and / or require access to a health facility, antiviral treatments that can be taken at home to prevent people with COVID-19 of the hospital are absolutely necessary, ”said Wendy Holman, CEO of Ridgeback Biotherapeutics, in a declaration announcing the results.

While molnupiravir has shown promise as a treatment for covid-19 for some time now, there has also been some controversy and failure surrounding it.

Last year, federal official and potential whistleblower Rick Bright alleged that the Trump administration retaliated against him for several decisions, including the reluctance by him and others to provide additional funding to the drug’s original founders at Emory University and later Ridgeback for their development of the drug, before and during the pandemic. Bright argued that the drug, while promising, already had sufficient resources, and he expressed concern that additional funding would reverse the normal process of research and development. He also noted that some animal studies had suggested that similar drugs could cause harmful mutations that could be passed on to children.

In April, Merck and Ridgeback Biotherapeutics also stopped part of their MOVe-OUT trial, after it was determined that there was insufficient evidence to support the use of molnupiravir for patients already in hospital. In all fairness, this has been a common pattern for many antivirals tested during the pandemic and is at least partially due to the fact that severe covid-19 disease tends to be caused by a destructive immune response, and not by the infection itself at this stage. . In addition, studies with molnupiravir don’t seem to have found any evidence of the harmful side effects Bright was concerned about, at least so far. Drugs suspected of causing mutagenic side effects have been approved in the past, usually with warnings against their use by people who are currently or planning to become pregnant.

Merck and Ridgeback now plan to immediately submit the drug for emergency use authorization. After that, the Food and Drug Administration and affiliated experts will need to look at the safety and testing data and discuss in detail the potential risks and benefits of the drug. If the drug gets cleared, it may not be alone for long – several other antiviral pills for the early treatment and prevention of covid-19 are to reach the end of their clinical trials as well. Generic antidepressant fluvoxamine has also been shown to significantly prevent hospitalization of covid-19 in a large-scale but not yet peer-reviewed trial.