Pfizer has commenced dosing in a pivotal randomised, double-blind Phase II/III clinical trial of its oral antiviral drug, PF-07321332, to treat Covid-19 in non-hospitalised patients who are at low risk of severe disease. The drug is a protease inhibitor developed to hinder the activity of the main protease enzyme that SARS-CoV-2 requires for replication. The study aims to recruit around 1,140 patients, who will receive a combination of PF-07321332 and ritonavir – another protease inhibitor, generally used as part of combination HIV therapies – or placebo.
Moderna has started its submission to the US Food and Drug Administration seeking authorisation for a booster shot of its Covid-19 vaccine, mRNA-1273, at the 50µg dose. The filing is backed by data demonstrating strong antibody responses against the SARS-CoV-2 Delta variant, the company said. These data will also be submitted to the European Medicines Agency and other global regulatory authorities soon.
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Merck and Ridgeback Biotherapeutics have launched the global Phase III MOVe-AHEAD trial of molnupiravir to prevent Covid-19. The trial will involve people aged 18 years and above who live in the same household as a symptomatic Covid-19 patient. Currently, the drug is in Part 2 of the Phase III MOVe-OUT trial to treat certain adult outpatients with mild to moderate Covid-19, with results expected in the coming months.
