Pfizer launches study of oral COVID-19 drug

March 23, 2021

Pfizer announced that it  is progressing to multiple ascending doses after completing the dosing of single ascending doses in a early-stage study in healthy adults to evaluate the safety and tolerability of a novel oral antiviral therapeutic for SARS-CoV-2. This Phase 1 trial is being conducted in the United States.

The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats. Protease inhibitors bind to a viral enzyme— protease—preventing the virus from replicating in the cell.

This treatment is being developed as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care.

The trial is a randomized, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of PF-07321332.

Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814.

Read the Pfizer statement