**Merck & Co – known as MSD outside of the US and Canada – and Ridgeback Biotherapeutics have initiated a late-stage study to evaluate an investigational oral antiviral COVID-19 drug in adults who are at high risk for disease progression.**
The phase 3 MOVe-NOW trial of orally-administered Lagevrio (molnupiravir) is enrolling patients who have tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalised.
Patients eligible for the study will also not be able to receive nirmatrelvir/ritonavir due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility, and will be randomised to receive either Lagevrio 800mg or placebo orally every 12 hours for five days.
Lagevrio is already available in the US under emergency use authorisation to treat adults with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19 and for whom alternative treatment options are not accessible or clinically appropriate.
MOVe-NOW will use a different formulation of the drug that includes two smaller 400mg tablets per dose instead of the currently available four 200mg capsules per dose.
Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “COVID-19 remains a leading cause of hospitalisation and death around the world, and further studying Lagevrio may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment.
“We continue to believe Lagevrio may be an important option for people with risk factors like older age, multiple comorbidities, and immunocompromising conditions, who are more likely to advance to severe COVID-19, and for whom other antiviral treatments may not be appropriate because of the potential for drug-drug interactions.”
The announcement comes just days after Merck shared positive top-line results from a late-stage trial of its pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk).
The phase 3 ZENITH study met its primary endpoint, with Winrevair demonstrating a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo in adults with World Health Organization functional classes three or four at high risk of mortality.