The drug will be a pill designed for a five day home treatment to stop the virus from causing major damage. Molnupiravir inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
Merck shared results from a phase 3 clinical trial studying 775 unvaccinated patients infected with confirmed cases of Covid-19. Merk enrolled almost 1,500 participants but the company said the FDA recommended stopping the trial early because of the positive results noted after an interim analysis was conducted.
Trial participants who received molnupiravir were hospitalized half as often as those treated with a placebo. Of the 385 patients treated with Merck’s antiviral, only 28 were hospitalized (7.3 percent). There were 53 hospitalizations from the 377 placebo-treated patients (14.1 percent). Eight of the control group patients, who were given placebos, died from Covid-19; none of the patients given molnupiravir died.
All patients were required to have at least one risk factor associated with poor disease outcome, according to a Merck press release. The company added that molnupiravir reduced the risk of hospitalization and/or death across all key subgroups and its effectiveness wasn’t affected by timing of symptom onset or underlying risk factors.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. The antiviral is being developed by Merck, in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and is eligible to receive contingent payments if certain developmental and regulatory approval milestones are met. Any profits from the collaboration will be split between the partners equally, according to Merck.
The big pharma company said it has been producing molnupiravir in anticipation of receiving EUA or full approval from the FDA and drug regulators in other countries, with almost 10 million doses expected by the end of this year.
Earlier this year, Merck entered contracted with the U.S. Government to supply around 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the FDA. The company also signed supply and purchase agreements for molnupiravir with other governments.
Merck CEO and President Robert M. Davis said, “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,”
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, CEO of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”
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