Merck and Ridgeback start phase 3 trial of COVID-19 oral antiviral for high-risk adults

Merck & Co, known as MSD outside the US and Canada, alongside Ridgeback Biotherapeutics, has embarked on an advanced stage clinical study to assess the effectiveness of an experimental oral antiviral medication for COVID-19. This drug is being tested in adults who are susceptible to severe disease progression. The trial, named MOVe-NOW, focuses on the oral delivery of Lagevrio (molnupiravir) and is currently enrolling participants who have tested positive for the SARS-CoV-2 virus, have been experiencing COVID-19 symptoms for four days or less, and have not been hospitalized.

To qualify for the study, participants must be unable to take nirmatrelvir/ritonavir due to potential drug interactions, allergies, previous negative reactions, or simply because it is unavailable to them. Those enrolled will be randomly assigned to receive either an 800mg dose of Lagevrio or a placebo, administered orally every 12 hours over a five-day period.

Lagevrio is already approved for emergency use in the United States. It is prescribed for adults exhibiting mild-to-moderate symptoms of COVID-19 who are at risk of progressing to more severe stages of the disease, especially when other treatment options are either not viable or contraindicated. The MOVe-NOW trial will use a revised version of the drug, consisting of two smaller 400mg tablets per dose, rather than the four 200mg capsules currently in use.

Paula Annunziato, the senior vice president of infectious diseases and global clinical development at Merck Research Laboratories, emphasized the importance of ongoing studies. She noted that COVID-19 continues to be a prevalent cause of hospitalizations and fatalities globally. Annunziato believes that further research into Lagevrio could yield critical understanding of its potential to prevent severe outcomes in the current global health environment. She underscored Lagevrio's potential significance for people with risk factors like older age, numerous comorbidities, and compromised immune systems. These individuals are more likely to develop severe COVID-19 and may not be suitable for other antiviral treatments due to possible drug interactions.

This announcement closely follows Merck's recent revelation of positive results from a separate late-stage trial involving Winrevair (sotatercept-csrk), a treatment for pulmonary arterial hypertension. The phase 3 ZENITH study achieved its primary goal, showing a statistically and clinically significant reduction in the risk of morbidity and mortality compared to a placebo in adults classified under World Health Organization functional classes three or four, who are at heightened risk of death.

In summary, the collaboration between Merck and Ridgeback Biotherapeutics on the MOVe-NOW trial seeks to expand the therapeutic options available for COVID-19, particularly for high-risk individuals. By testing a new formulation of Lagevrio, this study aims to provide further insights into the drug's effectiveness in curbing severe disease outcomes. This initiative is part of Merck's ongoing efforts to address critical health challenges posed by COVID-19, alongside their advancements in other therapeutic areas, such as pulmonary arterial hypertension.