Merck, known as MSD outside the US and Canada, and Ridgeback Biotherapeutics have announced that its MOV-e-AHEAD study has started to enrol its first participants to test antiviral molnupiravir in post-exposure prophylaxis of COVID-19 infection.
The global study will include approximately 1,332 participants who are 18 years or over and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection, has at least one sign or symptom of COVID-19 and has not had those signs and symptoms for more than five days.
Participants will be randomised onto molnupiravir, an investigational oral antiviral therapeutic, or placebo every 12 hours for 5 days. The trial will not look at vaccinated people, those who have had COVID-19 before or anyone showing signs or symptoms of infection.
Primary endpoints include the percentage of participants who are confirmed to have COVID-19 within two weeks and the percentage who experience an adverse event. The trial is being conducted globally in at least 17 countries, including the US, France and South Africa.
“As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” said Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, Merck Research Laboratories. “If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”
Molnupiravir is also currently being evaluated in the prevention of serious disease and death. The second stage of the MOVe-OUT trial – a global phase 3, placebo-controlled, double-blind, multi-site study – will see 1,850 people with COVID-19 and at least one risk factor for poor disease outcome given the drug or placebo to discover the percentage of participants who are hospitalised and/or die within 28 days.
It was recently announced that Health Canada will perform a rolling review of the MOV-e-OUT data, a move that demonstrates the huge unmet need for a convenient, oral antiviral against COVID-19. At present, Gilead’s Veklury (remdesivir) is being used to treat COVID-19 but only for people with more severe disease in hospital as it needs to be administered intravenously.
Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, although the drug was originally discovered at Drug Innovations at Emory (DRIVE), a non-profit biotech wholly owned by Emory University, a private research university based in Atlanta, Georgia.
US-based, Ridgeback is focused on emerging infectious diseases and markets monoclonal antibody Ebanga (ansuvimab-zykl) for the treatment of Ebola.