Coronavirus Drug Molnupiravir

Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, and Ridgeback Biotherapeutics announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 study in non-hospitalized high-risk adult patients with mild-to-moderate COVID-19. Therefore, at the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), enrollment in the study will be stopped early. Merck intends to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) as soon as possible, and plans to submit marketing applications to other regulatory agencies worldwide.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by about 50 %. 7.3 % of patients receiving molnupiravir were either hospitalized or died by day 29 following randomization (28/385), compared with 14.1 % of placebo-treated patients (53/377); p = 0.0012. No deaths were reported by day 29 in patients receiving molnupiravir compared with eight deaths in patients receiving placebo. The incidence of adverse events was comparable in the molnupiravir and placebo groups (35 % and 40 %, respectively). The incidence of drug-related adverse events was also comparable (12 % and 11 %, respectively). Molnupiravir showed consistent efficacy in gamma, delta, and mu viral variants based on participants with available viral sequencing data (approximately 40 % of participants).

Molnupiravir (MK-4482/EIDD-2801) was invented at Drug Innovations at Emory (DRIVE), LLC, a nonprofit biotechnology company wholly owned by Emory University, Atlanta, GA, USA, and is being developed by Merck & Co, Inc. in collaboration with Ridgeback Biotherapeutics. Molnupiravir is administered orally and is a ribonucleoside analog that inhibits replication of SARS-CoV-2, the causative agent of COVID-19. The drug has been shown to be effective in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.

The MOVe-OUT study (MK-4482-002) (NCT04575597) is a global, randomized, placebo-controlled, double-blind, multi-site Phase 3 study in non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19, at least one risk factor associated with poor disease outcome, and symptom onset within five days before randomization. The primary efficacy objective of the study is to evaluate the efficacy of molnupiravir compared to placebo based on the percentage of participants hospitalized and/or dying from the time of randomization through day 29.