KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

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Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European Medicines Agency (EMA) issued a positive scientific opinion for molnupiravir under Article 5.3 Regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. Regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare.

“In MOVe-OUT, molnupiravir significantly reduced the risk of hospitalization and death among a diverse population of patients at risk for more severe COVID-19. The increases in COVID-19 cases, hospitalizations and deaths being reported globally are a stark reminder that new tools are urgently needed, which is why we are moving with speed and rigor to obtain authorizations and to accelerate broad global access to this investigational medicine for appropriate patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Importantly, we observed consistent efficacy among patients with more common variants at the time, and more recent preclinical evidence indicates that molnupiravir has antiviral activity against Omicron, which is encouraging considering the uncertain future of a rapidly evolving virus such as SARS-CoV-2.”

“The publication of these positive results in the New England Journal of Medicine demonstrates that molnupiravir, which was studied as a single medicine that can be taken at home – regardless of food intake, with no known drug-drug interactions and without required dose modifications for those with kidney or liver impairment – has the potential to be a valuable addition to the therapeutic options available to fight COVID-19,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We are grateful for the efforts of the clinical trial participants and investigators and will continue to study molnupiravir for the treatment and prevention of COVID-19.”

“One of the hallmarks of the MOVe-OUT study is the diverse patient population, which included adults from 20 countries, with one or more risk factors such as obesity, advanced age, diabetes and serious heart conditions. Based on this study, molnupiravir has the potential to have a meaningful impact for patients, healthcare systems and public health,” said Dr. Monica Gomes, Universidade Federal do Paraná, Brazil.

About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) was 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. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice daily for five days compared to placebo as assessed by the percentage of patients who are hospitalized and/or die through Day 29.

Patients enrolled in the study had at least one risk factor associated with poor disease outcomes (age >60 years; active cancer; chronic kidney disease; chronic obstructive pulmonary disease; obesity; serious heart conditions; or diabetes mellitus), and symptom onset within five days prior to study enrollment. Key exclusion criteria were an anticipated need for hospitalization for COVID-19 within the next 48 hours, dialysis or estimated glomerular filtration rate less than 30 ml per minute per 1.73 m2, unwillingness to use contraception during the intervention period and for at least 4 days after completion of the regimen, severe neutropenia (absolute neutrophil count of