the staff of the Ridgewood blog
Ridgewood NJ, Pharmaceutical companies are pushing to develop more effective, easily administered therapeutics for COVID-19, some of which are being studied for the prevention of SARS-CoV-2 infection. This morning, Merck announced that its investigational oral antiviral molnupiravir, which is being developed with Ridgeback Biotherapeutics, significantly reduced the risk of hospitalization or death among non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms who were considered high risk due to other health conditions such as obesity, diabetes, or heart disease. Among patients who took a 5-day course of the drug, 7.3% (28/385) were hospitalized or died compared with 14.1% (53/377) of patients who took a placebo, according to the interim analysis of the Phase 3 MOVe-OUT trial. Merck said it will file an application for Emergency Use Authorization (EUA) with the US FDA as soon as possible, as well as filing applications for marketing with regulatory agencies globally. Over the summer, the US government announced plans to purchase 1.7 million courses of molnupiravir from Merck for about US$1.2 billion, pending US FDA authorization or approval. If authorized, the drug would become the first oral medication available to treat COVID-19.
Pfizer announced on September 27 that it has begun a large Phase 2/3 clinical trial—named EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis)—to evaluate its investigational oral antiviral drug candidate PF-07321332, administered with a low-dose of the antiviral ritonavir, for the prevention of SARS-CoV-2 infection. The global trial is a randomized, double-blind, placebo-controlled study that intends to enroll up to 2,660 healthy adult participants who live in the same household as someone with confirmed, symptomatic COVID-19 disease. In a different study, Pfizer is testing the experimental antiviral among non-hospitalized, symptomatic adult COVID-19 patients.
Swiss pharmaceutical company Roche also is reportedly developing similar treatments for COVID-19. So far, the FDA has approved only Gilead’s antiviral Veklury (remdesivir) for the treatment of COVID-19 in hospitalized patients. However, the drug’s intravenous or injection administration presents challenges to widespread use, so the authorization or approval of an effective orally administered COVID-19 treatment or preventive could help to lower the burden of patients on hospitals.