A pill that can effectively prevent the worst outcomes of COVID-19 could finally arrive.
On Friday, pharmaceutical companies Merck and Ridgeback Biotherapeutics announced the preliminary results of a large trial that tested their experimental antiviral drug, called molnupiravir. The drug reportedly reduced the chances of later hospitalization or death by about 50% in high-risk individuals with mild to moderate illness — the results were so dramatic that the trial was terminated prematurely. The companies now plan to seek approval for emergency use of the drug, although external scientists have not yet verified the findings.
Molnupiravir is said to act by interfering with the virus’s ability to replicate within host cells, hopefully limiting the viral load and allowing the immune system to clear the infection more quickly, without progressing to a more severe disease. The drug was in development before the pandemic as a potential cure for influenza and other viral illnesses.
A randomized, double-blind, controlled trial of Phase 3 molnupyvir, called MOVe-OUT, aimed to include about 1,500 unvaccinated patients who initially had mild to moderate covid-19 symptoms but were at greater risk of severe disease because of their already existing health. However, as usual, the researchers conducted a temporary analysis of the study when only 775 patients were treated. About 14% of those receiving placebo went to the hospital or died within 30 days, compared with about 7% of those taking molnupiravir. No deaths were reported in the treatment group, compared with eight deaths in the placebo group.
An independent council of outside scientists can stop clinical trials early because treatment seems so unlikely to work that it would be unethical to continue. But they can also be discontinued because treatment seems so much better than standard care that it would not be okay to enroll participants in a control or placebo group. And that’s what the independent committee agreed is the case here. Companies say more than 90% of trials have already been engaged by the time they are formally completed, so more data is likely to be conducted.
“As the virus continues to circulate widely, and as currently available therapeutic options are infused and / or require access to a health facility, antiviral treatments that can be taken at home are critical to keep people with COVID-19 out of the hospital,” , Said Wendy Holman, CEO of Ridgeback Biotherapeutics statement publishing results.
Although molnupiravir had been promising Covid-19 treatment for some time, there was controversy and failure around it as well.
Last year, federal official and possible whistleblower Rick Bright claimed that the Trump administration took revenge on him for several decisions, including reluctance from him and others to issue additional funds to the original founders of the drug at Emory University and later to Ridgeback for their drug development, before and during the pandemic. Bright argued that the drug, although promising, already has enough resources, and expressed concern that additional funding would disrupt the normal R&D process. He also noted that some animal studies have suggested that similar drugs can cause harmful mutations that can be transmitted to children.
In April both Merck and Ridgeback Biotherapeutics stopped one part of their MOVe-OUT trial, after it was found that there was insufficient evidence to support the use of molnupiravir for already hospitalized patients. Frankly, this was a common pattern for many antiviral drugs tested during a pandemic and is at least in part due to the fact that severe covid-19 disease is usually caused by a destructive immune response rather than the infection itself by that time. Moreover, studies on molnupiravir they don’t seem to have found evidence of the harmful side effects Bright has been 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 currently pregnant or those planning a pregnancy.
Merck and Ridgeback now plan to submit the drug immediately for approval for emergency use. Thereafter, the Food and Drug Administration and associated experts are expected to review the safety and testing data and discuss in detail the potential risks and benefits of the medicinal product. If the drug gets approval, it may not be long alone — several other antiviral pills for early treatment and prevention of covid-19 is reaching end of their clinical trials. Generic antidepressant fluvoxamine It has also been shown to significantly prevent hospitalization for COVID-19 in an extensive but not yet peer-reviewed study.
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