In a Phase 3 trial, Merck’s COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the virus. Halting the trial early due to the positive results, Merck and partner Ridgeback Biotherapeutics said Friday morning they would file for Emergency Use Authorization (EUA) in the U.S. as soon as possible, as well as with other governments around the world.
The MOVe-OUT trial was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes.
The trial was to enroll 1,550 patients, but an independent group monitoring the trial recommended stopping it early because the results were so strong. Thus, the planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or before Aug. 5, 2021.
According to the trial data, the pill—called molnupiravir—reduced the risk of hospitalization or death for those with mild to moderate COVID-19 by approximately 50%.
Among those taking molnupiravir, 7.3% were either hospitalized or died at the end of 29 days, compared with 14.1% of patients that received a placebo. After day 29, eight patients in the placebo group died, whereas no deaths were recorded in the patient group that received molnupiravir.
Additionally, of the 40% of participants who agreed to viral genome sequencing, molnupiravir demonstrated consistent efficacy across common SARS-CoV-2 variants, including Delta, Gamma and Mu.
Merck did not specify what drug-related side effects participants encountered; only saying that adverse events were comparable across the molnupiravir and placebo groups—12% and 11%, respectively. More participants in the placebo group (3.4%) pulled out of the trial due to side effects than did participants in the molnupiravir group (1.3%).
“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,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “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.”
Molnupiravir is an orally administered form of a ribonucleoside analog that interferes with an enzyme SARS-CoV-2 uses to copy its genetic code and replicate. The drug was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company owned by Emory University.
Merck, anticipating positive results from MOVe-OUT, has already been manufacturing molnupiravir. The pharmaceutical giant said it expects to produce 10 million courses of treatment by the end of this year. To aid distribution, Merck has also already entered into supply and purchase agreements with the U.S. and other governments worldwide.
Under a procurement agreement with the U.S., Merck said it will supply approximately 1.7 million courses of molnupiravir upon EUA or approval from the U.S. FDA.
Additionally, Merck has entered into agreements with generic manufacturers in more than 100 low- and middle-income countries to accelerate availability of molnupiravir in these locations following local regulatory approval.
Molnupiravir is also currently involved in the Phase 3 MOVe-AHEAD trial, which is evaluating the efficacy and safety of the drug in preventing the spread of COVID-19 within households.
Photo: Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2. Credit: Merck & Co.