Molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate COVID-19.-Merck Inc., + Ridgeback Biotherapeutics.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 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); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application 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.

About the Results of the Planned Interim Analysis: The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to Aug. 5, 2021. At the time of the decision to stop recruitment based on the compelling interim efficacy results, the trial was approaching full recruitment of the Phase III sample size of 1,550 patients, with more than 90% of the intended sample size already enrolled.

The incidence of any adverse event was comparable in the molnupiravir and 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%).