Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)July 12, 2021
KENILWORTH, N.J. & MIAMI–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The Phase 3 portion of the global MOVe-OUT trial studying molnupiravir in non-hospitalized adult patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes is underway. In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021.
“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If successful, molnupiravir could help address the continued urgent need for therapeutics.”
“These data are promising, and we are pleased to be able to present the Phase 2 interim results for molnupiravir while we proceed with the Phase 3 portion of MOVe-OUT in non-hospitalized patients,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “There remains a great need for a range of solutions for the pandemic, and we are hopeful that molnupiravir will play a role in helping patients.”
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable 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 models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 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 EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck.