Deena Beesley

(Reuters) – Merck & Co Inc’s experimental oral drug for COVID-19, molnupiravir, reduced by around 50% the chance of hospitalization or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and Ridgeback Biotherapeutics will seek U.S. Emergency Use Authorization for the Pill as quickly as possible. They also plan to file applications with regulatory agencies around the world. At the suggestion of external monitors, Phase 3 is being halted early due to positive results.

Robert Davis (Merck’s chief executive officers) stated to Reuters that “this is going to transform the dialogue around COVID-19 management.”

Molnupiravir would become the first approved oral antiviral drug for COVID-19. This medication is intended to cause errors in the DNA of the virus.

Rivals include Pfizer Inc (NYSE:) and Swiss pharmaceutical Roche Holding AG (OTC:) are racing to develop an easy-to-administer antiviral pill https://www.reuters.com/business/healthcare-pharmaceuticals/covid-19-pill-developers-aim-top-merck-pfizer-efforts-2021-09-28 for COVID-19 but so far, only antibody cocktails – which have to be given intravenously – are approved for treating non-hospitalized COVID-19 patients.

Merck’s interim analysis found 7.3% of molnupiravir-treated patients were in the hospital or dead by 29 days, as compared to 14.1% for placebo. However, there were only eight deaths among the patients receiving molnupiravir.

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

Patients from around the globe were enrolled in the study. For five days, they received molnupiravir every twelve hours.

Participants in this study were patients who presented with symptoms lasting no longer than five days and had laboratory confirmed mild-to-moderate coVID-19. Each patient had at minimum one risk factor for poor outcome such as older age or obesity.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-research-shows-its-covid-19-pill-works-against-variants-2021-09-29 of the coronavirus, including highly transmissible Delta.

Although the company stated that adverse event rates were comparable for patients receiving molnupiravir as well as placebo, it did not provide details about side effects.

Merck stated that research shows that molnupiravir does not induce any genetic changes within human cells. Men who participate in Merck’s trials are required to either agree to have contraception or abstain form heterosexual relations. The law prohibits women of child bearing age from becoming pregnant. They also need to be on birth control.

Merck stated that it anticipates producing 10 million doses of the treatment before the year 2021. More dosages will be available next year.

American government contracts have been awarded to the company for supplying 1.7 millions courses of molnupiravir. The cost per course is $700

Davis stated that Merck had similar agreements with several governments across the globe and was in negotiations to expand these relationships. According to the company, it will implement tiered pricing based on income in each country.

Merck agreed also to license the drug for several India-based generic drugmakers. This would allow them to provide the medication to low- to middle-income countries.

A Phase 3 study of Molnupiravir to prevent coronavirus infections in patients exposed to it is being conducted.

According to Merck, it’s not known how long FDA reviews of the drug can take.

Dean Li of Merck’s research laboratory, stated that “I think they are going to attempt to work with alacrity here.”