FDA Clears Pardes IND Application for COVID Antiviral Candidate

Pardes Biosciences, Inc., a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), announced that its Investigational New Drug ( IND ) application for PBI-0451 has been cleared by the U.S. FDA .

PB-0451 is currently being evaluated 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.

“As we enter our third year of a global pandemic, we believe the value of oral direct-acting antivirals for SARS-CoV-2 has become increasingly clear, especially if they can be given as standalone therapies,” said Uri A. Lopatin, M.D., Chief Executive Officer. “The clearance of our IND for PBI-0451 enables us to proceed with the initiation of additional Phase 1 clinical trials for PBI-0451 in the U.S. Pending additional engagement with FDA and other regulators, we anticipate initiating our global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022.”