Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection.
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The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms.
The safety and efficacy of molnupiravir is also currently being evaluated in Part 2 of the ongoing MOVe-OUT trial, which is a global Phase 3, 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.
MOVe-AHEAD (MK-4482-013) (NCT04939428) is a Phase 3 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 SARS-CoV-2, the virus that causes COVID-19, within households.
The trial will enroll approximately 1,332 participants who will be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for five days.
The study will enroll participants who are at least 18 years of age and currently residing in the same household with someone who received a positive test for SARS-CoV-2, has at least one sign or symptom of COVID-19 and has not had those signs and symptoms for more than five days.
Participants are not eligible for the trial if they have received the first dose of a COVID-19 vaccine more than seven days prior to enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19.
The primary endpoints of the trial include percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention due to an adverse event.
The trial is being conducted globally in countries including Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the United States.
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19.
Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Wayne and Wendy Holman and Merck. ■
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