Oral Medicine Significantly Reduced COVID-19 Hospitalization or Death Risk
Florida-based Merck Ridgeback Biotherapeutics and Merck today announced that an investigational oral antiviral medicine known as molnupiravir (MK-4482, EIDD-2801) significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT clinical trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.
At the Interim Study Analysis, 7.3% of patients who received molnupiravir were hospitalized through Day 29, compared with 14.1% of Placebo-Treated Patients who were hospitalized or died.
Merck stated in a press release it plans to seek Emergency Use Authorization in the U.S. and submit Applications to Regulatory Agencies worldwide. If Authorized, molnupiravir could be the first Oral Antiviral Medicine for COVID-19.
Robert M. Davis, CEO and president, Merck, commented, “On behalf of all of us at Merck, I thank our network of clinical investigators and patients for their essential contributions to the development of molnupiravir.”
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases.