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NEW JERSEY (REUTERS) - Merck & Co's experimental oral drug for Covid-19, molnupiravir, reduced by around 50 per cent the chance of hospitalisation or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday (Oct 1).
Merck and partner Ridgeback Biotherapeutics plan to seek US emergency use authorisation for the pill as soon as possible, and to submit applications to regulatory agencies worldwide.
Due to the positive results, the phase three trial is being stopped early at the recommendation of outside monitors.
"This is going to change the dialogue around how to manage Covid-19," Merck chief executive officer Robert Davis told Reuters.
If authorised, molnupiravir, which is designed to introduce errors into the genetic code of the coronavirus, would be the first oral antiviral medication for Covid-19.
Rivals, including Pfizer and Swiss pharmaceutical firm Roche Holding, are racing to develop an easy-to-administer antiviral pill for Covid-19, but so far, only antibody cocktails - which have to be given intravenously - are approved for treating non-hospitalised Covid-19 patients.
Seven per cent of volunteers in the group that received the drug were hospitalised, and none of them died, compared with a 14 per cent rate of hospitalisation and death - including eight deaths - in the group that received the placebo.
"Antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed," Ms Wendy Holman, Ridgeback's CEO, said in a statement.
In the trial, which enrolled 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 symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including the highly transmissible Delta variant.
The company said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details of the side effects.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age cannot be pregnant and also have to use birth control.
Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year.
The company has a United States government contract to supply 1.7 million courses of molnupiravir at a price of US$700 (S$950) per course.
Mr Davis said Merck has similar agreements with other governments worldwide, and is in talks with more. The company said it plans to implement a tiered pricing approach based on country income criteria.
Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a phase three trial for preventing Covid-19 infection in people exposed to the virus.
Merck officials said it is unclear how long the US Food and Drug Administration's (FDA) review of the drug will take.
Dr Dean Li, head of Merck's research labs, said he believed that the FDA is going "to try to work with alacrity on this".
www.straitstimes.com
Merck and partner Ridgeback Biotherapeutics plan to seek US emergency use authorisation for the pill as soon as possible, and to submit applications to regulatory agencies worldwide.
Due to the positive results, the phase three trial is being stopped early at the recommendation of outside monitors.
"This is going to change the dialogue around how to manage Covid-19," Merck chief executive officer Robert Davis told Reuters.
If authorised, molnupiravir, which is designed to introduce errors into the genetic code of the coronavirus, would be the first oral antiviral medication for Covid-19.
Rivals, including Pfizer and Swiss pharmaceutical firm Roche Holding, are racing to develop an easy-to-administer antiviral pill for Covid-19, but so far, only antibody cocktails - which have to be given intravenously - are approved for treating non-hospitalised Covid-19 patients.
Seven per cent of volunteers in the group that received the drug were hospitalised, and none of them died, compared with a 14 per cent rate of hospitalisation and death - including eight deaths - in the group that received the placebo.
"Antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed," Ms Wendy Holman, Ridgeback's CEO, said in a statement.
In the trial, which enrolled 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 symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including the highly transmissible Delta variant.
The company said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details of the side effects.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age cannot be pregnant and also have to use birth control.
Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year.
The company has a United States government contract to supply 1.7 million courses of molnupiravir at a price of US$700 (S$950) per course.
Mr Davis said Merck has similar agreements with other governments worldwide, and is in talks with more. The company said it plans to implement a tiered pricing approach based on country income criteria.
Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a phase three trial for preventing Covid-19 infection in people exposed to the virus.
Merck officials said it is unclear how long the US Food and Drug Administration's (FDA) review of the drug will take.
Dr Dean Li, head of Merck's research labs, said he believed that the FDA is going "to try to work with alacrity on this".
Merck says Covid-19 antiviral pill halves hospitalisations, deaths
Merck plans to seek US emergency use authorisation for the pill molnupiravir as soon as possible. Read more at straitstimes.com.
Prometheus!!!
