Merck (MSD) and Ridgeback Biotherapeutics have sought an emergency use authorisation from the US Food and Drug Administration for an experimental oral antiviral drug, molnupiravir, to treat Covid-19. The therapy is intended for adult patients with mild-to-moderate Covid-19, who are at risk of progression to severe disease and/or hospitalisation. The application is based on positive interim analysis data from the Phase III MOVe-OUT trial of molnupiravir in adult Covid-19 patients in the non-hospital setting.
AstraZeneca has reported that its long-acting antibody combination, AZD7442, showed a statistically significant decline in severe Covid-19 or mortality in patients suffering from mild-to-moderate symptomatic Covid-19 and are not hospitalised. The Phase III TACKLE trial, which included 903 participants, also met the primary goal. AZD7442 was demonstrated to be beneficial in prophylaxis as well as treatment of Covid-19.
Colombia’s National Food and Drug Surveillance Institute INVIMA has authorised Inovio to carry out the Phase III portion of the Phase II/III INNOVATE trial of its Covid-19 vaccine candidate, INO-4800, in the country. Collaborating with Advaccine Biopharmaceuticals Suzhou, Inovio is conducting the trial in a number of nations worldwide. The trial will assess the efficacy of a two-dose regimen of INO-4800 in adults, with doses administered a month apart.