Merck’s COVID-19 pill reduces risk of death and hospitalization by 50% in study

Oct. 1 (Reuters) – Merck & Co Inc’s (MRK.N) investigational oral drug for COVID-19, molnupiravir, reduced the risk of hospitalization or death for patients at risk of disease by about 50% serious, according to interim results from clinical trials announced Friday.

Merck and its partner Ridgeback Biotherapeutics plan to apply for emergency use authorization in the United States for the pill as soon as possible and to submit applications to regulatory agencies around the world. Due to the positive results, the phase 3 trial was terminated prematurely on the recommendation of external monitors.

“This will change the dialogue on how to deal with COVID-19,” Robert Davis, chief executive of Merck, told Reuters.

If licensed, molnupiravir, which is designed to introduce errors into the virus’s genetic code, would be the first oral antiviral drug for COVID-19.

The news sent Merck shares up nearly 8% in pre-market trading in New York.

Rivals including Pfizer Inc (PFE.N) and Swiss pharmaceutical company Roche Holding AG (ROG.S) rush to develop easy-to-administer antiviral pill for COVID-19 but so far only cocktails of antibodies – which must be administered intravenously – are approved for the treatment of non-hospitalized COVID-19 patients.

A planned interim analysis of 775 patients in the Merck study found that 7.3% of those who received molnupiravir were either hospitalized or died 29 days after treatment, compared with 14.1% of patients on placebo. There were no deaths in the molnupiravir group, but there were eight deaths of patients on placebo.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of hospital are badly needed,” Ridgeback CEO Wendy Holman said in a statement.

Scientists hailed the potential new treatment to help prevent serious illnesses caused by the virus, which has killed nearly 5 million people worldwide.

“The availability of an effective and well-tolerated oral antiviral will be particularly useful as a complement to vaccination in order to reduce the proportion of patients requiring hospital care,” said Professor Penny Ward, visiting professor of pharmaceutical medicine at King’s College London.

In the trial, which recruited patients from around the world, molnupiravir was taken every 12 hours for five days.

The study recruited patients with laboratory-confirmed mild to moderate COVID-19 who had symptoms for up to five days. All patients had at least one risk factor associated with poor disease progression, such as obesity or advanced age.

Merck said viral sequencing done so far shows molnupiravir to be effective against all variants of the coronavirus, including the highly transmissible Delta.

The company said the rates of adverse events were similar for patients on molnupiravir and on placebo, but did not give details of side effects.

Merck said data shows molnupiravir is not able to induce genetic changes in human cells, but men in its trials must refrain from heterosexual intercourse or agree to use contraception. Women of childbearing age cannot be pregnant and must also use birth control.

Merck said it plans to produce 10 million treatment cycles by the end of 2021, with more doses coming next year.

The company has a contract with the US government to provide 1.7 million courses of molnupiravir at a cost of $ 700 per course.

CEO Davis said Merck has similar agreements with other governments around the world and is in talks with others. The company said it plans to implement a tiered pricing approach based on the country’s income criteria.

Merck also agreed to license the drug to several generic drug manufacturers based in India, who would be able to provide the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a phase 3 trial to prevent coronavirus infection in people exposed to the virus.

Merck officials said it was unclear how long the drug was under review by the FDA.

“I think they will try to work diligently on this,” said Dean Li, head of Merck’s research labs.

Reporting by Deena Beasley; Additional reporting by Josephine Mason, editing by Lincoln Feast, Kirsten Donovan

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