Pardes Biosciences IND Application for SARS-CoV-2 Treatment Cleared By FDA

 Pardes Biosciences Inc. said its investigational new drug application for PBI-0451, a candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases, has been cleared by the U.S. Food and Drug Administration.

The company said the clearance allows it 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, the company sees beginning its global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022.

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.

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