- Merck’s drug, molnupiravir, stops viruses like the coronavirus from making copies of itself and spreading throughout the body
- Researchers tracked 775 adults with mild to moderate COVID-19 who were considered to be at high risk for severe illness because of health problems
- The study found that 7.3% of the treatment group were either hospitalized or died at the end of 30 days, compared with 14.1% of those taking the dummy pill.
- If approved by the FDA, molnupiravir would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic.
- All current COVID-19 treatments authorized in the US require an IV or injection
Merck & Co. announced Friday that its experimental COVID-19 pill has cut hospitalizations and deaths by half in high-risk patients who were recently infected with the virus.
The medicine, called mollupiravir, stops the virus from making copies of itself, which stops it from spreading throughout the body.
Merck and its partner Ridgeback Biotherapeutics said early results showed that patients who received mollupiravir within five days of symptoms of COVID-19 had nearly half the rate of hospitalization and death. , who had received a placebo.
The companies plan to apply for emergency use authorization with the US Food and Drug Administration (FDA), as well as with authorities around the world.
If approved, Merck’s drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic.
The drug, along with Merck & Co.’s partner Ridgeback Biotherapeutics, molnupiravir (above), stops viruses like the coronavirus from making copies of itself and spreading throughout the body.
One study found that 7.3% of mild to moderate COVID-19 patients treated with the drug were either hospitalized or died at the end of 30 days, compared with 14.1% of those taking the dummy pill. in comparison. Image: Medical staff treat a COVID-19 patient in Wuhan, February 2020
Molnupiravir is an antiviral drug that was developed at Emory University in Atlanta by its drug innovation company, Drug Innovation Ventures at Emory (DRIVE), which was licensed by Ridgeback Biotherapeutics, which partnered with Merck & Co.
It was originally intended to treat influenza and prevent the virus from making copies of itself by making errors during viral RNA replication.
Animal studies conducted last year found that mollupiravir can completely suppress viral transmission and prevent and reduce severe lung damage.
The new study tracked 775 adults with mild to moderate COVID-19 who were considered at high risk for severe disease because of health problems such as obesity, diabetes or heart disease.
Among patients taking molanupiravir, 7.3 percent were either hospitalized or died at the end of 30 days, compared with 14.1 percent of those taking the dummy pill.
According to Merck, there were no deaths in the drug group after that time period, compared to eight deaths in the placebo group.
The results were released by the company and have not been reviewed, but Merck says it plans to present them at a future medical meeting.
If approved by the FDA, Merck’s drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. Image: Merck logo at the gate of the Merck & Company campus in Rahway, New Jersey, July 2018
An independent group of medical experts overseeing the trial recommended stopping it early because the interim results were so strong.
Company officials said they are in discussions with the FDA and plan to submit the data for review in the coming days.
“I wondered what the drug might be able to do in this clinical trial,” Dr. Dean Lee, Merck Research vice president, told the Associated Press.
‘When you see a 50 percent reduction in hospitalizations or deaths, that’s a substantial clinical effect.’
Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Results from an earlier study showed that the drug did not benefit patients who were already hospitalized with serious illness.
The US has approved remdesivir, an antiviral drug specifically for COVID-19, and allowed the emergency use of three monoclonal antibody therapies that help the immune system fight the virus.
Merck’s drug was shown to be of low efficacy as monoclonal antibody treatments — which mimic the antibodies the body produces when fighting viruses to boost the immune system — prevent hospitalizations and deaths by about 75 percent. Percentage to 80 percent has been shown to be effective.
But all drugs have to be injected by IV or in hospitals or medical clinics — making them longer and costly to administer — and the latest surge of the Delta version has bolstered supplies.
Health experts including America’s top infectious disease expert, Dr. Anthony Fauci, have long called for a convenient pill that patients can take when COVID-19 symptoms first appear, just like the decades-old flu. The drug Tamiflu helps fight influenza.
Such drugs are seen as the key to controlling future waves of infection and mitigating the impact of the pandemic.
The US government has committed to purchase 1.7 million doses of the drug if authorized by the FDA.
Merck has said it can produce 10 million doses by the end of the year and has contracts with governments around the world. The company has not announced the prices.
Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report late-stage results in the coming weeks and months.