Merck and Ridgeback Biotherapeutics released preliminary results on Friday that suggest their investigational oral antiviral medication molnupiravir may reduce the risk of mortality or hospitalization caused by Covid-19 by half.
According to the firm, Covid-19 caused hospitalization or death in 7.3 percent of 385 individuals who got the antiviral, compared to 14.1 percent of 377 people who received a placebo,
which does nothing.
The molnupiravir trial data has yet to be disclosed in its entirety,
and it has not been peer-reviewed or published.
However, Merck says it will apply for approval from the US Food and Medication Administration,
and if approved, the drug may be the first antiviral therapy for Covid-19 accessible orally.
Dr. Scott Gottlieb, the former commissioner of the US Food and Medication Administration,
told CNN’s Anderson Cooper on Friday, “This is the most dramatic outcome that I recall seeing of an orally accessible drug in the treatment of a respiratory infection, maybe ever.”
“I believe that developing an oral tablet that inhibits viral reproduction,
that inhibits this virus — will be a game-changer.”
Antiviral therapies are a kind of antimicrobial therapy that kills or inhibits the growth of microorganisms such as bacteria (antibiotics), fungus (antifungals), or, in this instance, a virus.
Antivirals designed to treat herpes, HIV, and the flu are among the most well-known.
“Most people have heard of Tamiflu and acyclovir,” said Dr. Myron Cohen, a University of North Carolina professor of medicine, microbiology, immunology,
and epidemiology. Chickenpox, herpes, and shingles are all treated with acyclovir, a kind of antiviral.
He said, “We didn’t create a lot of additional antivirals.”
What makes molnupiravir different.
Remdesivir, another antiviral, is presently the sole FDA-approved medication for the treatment of Covid-19. Remdesivir,
which is manufactured by Gilead Sciences and marketed under the brand name Veklury, is given through intravenous infusion rather than a tablet.
Also, redeliver isn’t effective in all Covid-19 sufferers. It doesn’t seem to decrease the chance of mortality,
but it does appear to help patients feel better quicker when taken early in an illness, according to studies.
Remdesivir recommends for hospitalized Covid-19 patients who need supplementary oxygen by the National Institutes of Health’s Covid-19 treatment recommendations,
however, the World Health Organization advises against using it outside of research studies.
Molnupiravir would be more convenient for patients since it would not need an IV and acts in a different way,
by altering the SARS-CoV-2 virus to prevent reproduction.
In a meeting with the Scientific Media Center in the UK on Friday,
Dr. Daria Hazuda, chief science officer of MSD, Merck’s label operating outside of the US and Canada,
said, “It really becomes absorbed into the genetic makeup of the virus and causes mistakes.”
“As a result, the mistakes reduce the virus’s ability to reproduce over time.”
The method molnupiravir works, termed mutagenesis, is what distinguishes it from redeliver,
according to Dr. Mark Denison, a virologist at the Vanderbilt Institute for Infection,
Immunology, and Inflammation.
“Chain termination, which I refer to as the delayed stop sign,
or mutagenesis, which is similar to blowing potholes in the road while driving, are the two main processes. It’s just causing harm to the DNA “He told CNN about it.
Cohen, who previously worked on molnupiravir, said he looks for three things in findings for an antiviral medication like molnupiravir.
“Stop disease progression, so you take them and forget about it?” he said.
“If you’re taking the pill for symptomatic illness, the second thing we’d want it to do is discontinue long-acting Covid, right? It’s not only a case of ‘Don’t let me grow worse and die,’
but also ‘Don’t let me have a persistent cough and headache.'”
Cohen’s final aim is for “therapy to function as preventive,” meaning that those who have Covid-19 are less likely to spread it to others.
He added, “We’d want it to wipe out SARS-CoV-2 replication in the nose so quickly that your nose is no longer a threat to me.”
Dr. Leana Wen, former Baltimore City Health Commissioner,
and CNN Medical Analyst said on Friday that having an antiviral medication that may prevent a Covid-19 infection from becoming serious is “critical.”
“Monoclonal antibodies that accomplish this already exist and are very effective. The issue is that they require an infusion or injection.
That is very taxing for the person, as well as the health-care system “She was referring to Regeneron, Eli Lilly, GlaxoSmithKline, and Vir’s Covid-19 therapies.
“It would be a game-changer if someone diagnosed with mild Covid could take a tablet at home early on in their therapy.
The healthcare system will be less burdened as a result.
This is also very beneficial to the person “Even so, an antiviral can’t take the place of vaccination. During a briefing on Friday,
White House Covid-19 Response Coordinator Jeff Zients noted that the best approach to conceive of such a medicine is as a supplement to vaccines.
“This may be another weapon in our arsenal to shield patients against Covid’s worst effects,” Zients added.
“I believe it’s important to remember that, as we’ve discussed today, immunization remains by far our most effective weapon against Covid-19.
It has the potential to prevent you from being infected with Covid in the first place. And we want to avoid illnesses rather than simply cure them when they occur.”
What’s next for molnupiravir
There’s still a lot we don’t know about the medication and who it might help.
Adult patients who were deemed high-risk for severe Covid-19, most often because of obesity, advanced age, diabetes, or heart disease, were the subject of the study, which was announced on Friday.
Covid-19 had not been immunized against.
Molnupiravir is also being investigated as post-exposure prophylaxis, with the goal of preventing the virus from spreading within homes after someone has been infected but has not yet tested positive.
Merck said on Friday that it intends to submit an emergency use permit application to the FDA as soon as feasible, as well as to other regulatory authorities across the globe.
The firm said it has started manufacturing molnupiravir at risk in anticipation of the study findings and intends to have 10 million treatment sessions accessible by the end of the year.
If the FDA gives Merck permission or clearance, it has already sold 1.7 million treatment courses to the US government.
The firm claimed it would provide tiered pricing to enable access to people all around the globe, and it will collaborate with generic medication makers to help low- and middle-income nations get their medicines faster.