Merck’s experimental oral drug for COVID-19, molnupiravir, reduced by about 50% the chance of hospitalization or death for patients at risk of serious illness, according to preliminary results of clinical trials announced Friday.
Merck and partner Ridgeback Biotherapeutics plan to apply for US emergency palliative care permits as soon as possible and submit applications to regulatory agencies worldwide. Due to the positive results, the phase 3 trial is stopped early on the recommendation of external monitors.
“This is going to change the dialogue on how to deal with COVID-19,” Robert Davis, Merck’s CEO, told Reuters.
If approved, molnupiravir, designed to introduce errors into the genetic code of the virus, would be the first oral antiviral drug for COVID-19.
Rivals, including Pfizer Inc and the Swiss drug Roche Holding AG, are running after developing an easy-to-administer antiviral pill for COVID-19, but so far only antibody cocktails – to be given intravenously – are approved for the treatment of non-hospitalized COVID -19 19 patients.
A planned temporary analysis of 775 patients in Merck’s study showed that 7.3% of those receiving molnupiravir were either hospitalized or died 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.
“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Ridgeback CEO Wendy Holman said in a statement.
In the trial, which registered patients around the world, molnupiravir was taken every 12 hours for five days.
The study enrolled patients with laboratory-confirmed mild to moderate COVID-19 who had no symptoms for more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or old age.
Merck said that viral sequencing performed so far shows that molnupiravir is effective against all variants of coronavirus, including highly transmissible Delta.
The company said the number of side effects was similar for both molnupiravir and placebo patients, but did not provide details on the side effects.
Merck has said that data show that molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in the trials must refrain from heterosexual intercourse or agree to use contraception. Women of childbearing potential cannot be pregnant and must also use contraception.
Merck said it expects to produce 10 million treatment courses by the end of 2021, with more doses coming next year.
The company has a US government contract to supply 1.7 million courses of molnupiravir at a cost of $ 700 per year. Course.
CEO Davis said Merck has similar agreements with other governments worldwide and is in negotiations with several. The company said it plans to implement a step-by-step pricing based on the country’s income criteria.
Merck has also agreed to license the drug to several Indian-based generic drug manufacturers who would be able to deliver the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a Phase 3 trial to prevent coronavirus infection in humans exposed to the virus.
Merck officials said it is unclear how long the FDA review of the drug will take.
“I believe they will try to work with ease on this,” said Dean Li, head of Merck’s research laboratories.