Merck and Ridgeback Biotherapeutics announced in a release that Molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.
At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into a study of a Merck and Ridgeback Biotherapeutics study on the effectiveness of an oral antiviral medicine for treatment of COVID-19 is being stopped early due to positive results.
Merck intends to apply for Emergency Use Authorization (EUA) to the FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide
At the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received the drug were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received the drug, as compared to 8 deaths in patients who received placebo.
Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry.
Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), Molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta and Mu.
The incidence of any adverse event in the Molnupiravir group members was comparable to those in placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the Molnupiravir group (1.3%) compared to the placebo group (3.4%).
In anticipation of the results from MOVe-OUT, Merck has been producing Molnupiravir. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022
Merck entered into a procurement agreement with the U.S. Government earlier this year under which the company 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 the drug with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Pending approval, Merck plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements with established generic manufacturers to accelerate availability of the drug in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
