Merck and Ridgeback Biotherapeutics Initiate Phase III Trial to Evaluate Molnupiravir for COVID-19

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced the initiation of the Phase III MOVe-AHEAD clinical trial to evaluate molnupiravir—an investigational oral antiviral therapeutic—for the prevention of COVID-19 infection in a Sept. 1, 2021 press release. The global study is enrolling individuals 18 years of age and older who reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms.

MOVe-AHEAD is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of COVID-19 within households. Approximately 1,332 participants will be enrolled and randomized to receive either 800 mg of molnupiravir or placebo orally every 12 hours for five days. The trial is being conducted globally, including countries such as Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the United States.

In addition, the safety and efficacy of molnupiravir is being evaluated in part two of the ongoing MOVe-OUT trial, which is a global Phase III, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. Data from the study is expected in the second half of 2021.

Source: Merck