Relief for COVID-19 patients as Merck pill may halve hospitalizations, deaths

• Molnupiravir is most effective within five days of novel coronavirus infection

U.S. administration proposes to buy 1.7 million doses of the pill if passed by FDA

• Merck & Co. (NYSE: MRK) says it plans to seek a regulatory nod for its COVID-19 pill that it claims can reduce hospitalizations and death by half.

The pharma major will soon approach health officials in the U.S. and around the world for authorizing its use.

Merck's drug promises to be the pill that cures COVID-19 by oral application, a potentially a major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection, an AP report says.

Merck and its partner Ridgeback Biotherapeutics said early results showed patients, who received Molnupiravir within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill.

Future medical meeting

The study tracked 775 adults with mild-to-moderate COVID-19 considered higher risk for severe disease due to health problems like obesity, diabetes or heart disease.

Among patients taking Molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, Merck said. The results were released by the company and have not been peer-reviewed. Merck said it plans to present them at a future medical meeting.

An independent group of medical experts monitoring the trial recommended stopping it early based on the strong interim results. Company executives are in discussions with the Food and Drug Administration and plan to submit the data for review soon.

Substantial clinical impact

"It exceeded what I thought the drug might be able to do in this clinical trial," said Dr. Dean Li, vice-president of Merck research. "When you see a 50% reduction in hospitalization or death that's a substantial clinical impact."

Side effects were slightly more common among the group that received a dummy pill when compared to those who received the Merck pill.

Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease.

The U.S. has approved the antiviral drug Remdesivir specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all the drugs are given by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the delta variant.

U.S. infectious disease expert Dr. Anthony Fauci has been in the forefront of health experts calling for a “convenient” pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old flu medication Tamiflu helps fight influenza. Such medications are key to controlling future waves of infection and reducing the impact of the pandemic.

Interference with enzyme

Merck's pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.

The U.S. government has committed to purchase 1.7 million doses of the drug if it is authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide. The company has not announced prices, AP says.

Several other companies, including Pfizer (NYSE: PFE) and Roche, are studying similar drugs that could report results in the coming weeks and months.

Merck had planned to enroll more than 1,500 patients in its late-stage trial before the independent board stopped it early. The results reported on Friday included patients enrolled across Latin America, Europe and Africa. Executives estimated about 10% of patients studied were from the U.S.

With Associated Press

Picture credit: Merck & Co.