Pardes Biosciences, Inc. announced that its Investigational New Drug application for PBI-0451 has been cleared by the United States Food and Drug Administration (FDA). PB-0451 is currently under evaluation in a Phase 1 placebo-controlled, blinded, randomized, dose escalation study in healthy volunteers in New Zealand evaluating the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses. Pardes anticipates reporting data from this ongoing study at a scientific conference later this quarter.

PBI-0451 is an investigational orally bioavailable direct-acting antiviral (DAA) inhibitor of the main protease (Mpro), an essential protein required for the replication of coronaviruses, including the novel SARS-CoV-2 that causes COVID-19. This protease is highly similar across all coronaviruses, including known and emerging coronavirus variants. PBI-0451 is being developed for the treatment and prevention of SARS-CoV-2 infection and associated diseases.

PBI-0451 is currently in a Phase 1 placebo-controlled, blinded, randomized, dose escalation study in healthy volunteers in New Zealand evaluating the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses.