Merck and Ridgeback Biotherapeutics announced that the companies’ investigational oral antiviral medicine significantly reduced the risk of hospitalization or death in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.
In an interim analysis of a Phase 3 study, the antiviral medication, molnupiravir, reduced the risk of hospitalization or death by approximately 50%. Approximately 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) through day 29. No deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received a placebo.
At the recommendation of an independent data monitoring committee and in consultation with the U.S. Food and Drug Administration (FDA), Merck said the companies stopped recruitment into the study early due to these results.
Merck also said it plans to submit an application for emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide. If authorized, molnupiravir could be the first oral antiviral medicine for COVID-19, Merck says.
The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to August 5, 2021. At the time of the decision to stop recruitment based on the interim efficacy results, the trial was approaching full recruitment of the Phase 3 sample size of 1,550 patients, with more than 90% of the intended sample size already enrolled.
Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the U.S. government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the FDA. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a biotechnology company focused on emerging infectious diseases.