The FDA has signed off Pardes Biosciences Inc's (NASDAQ:PRDS) Investigational New Drug (IND) application for PBI-0451 for COVID-19.
- Pending further engagement with FDA and other regulators, the Company anticipates initiating global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022.
- "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.," said Uri Lopatin, Chief Executive Officer.
- PB-0451 is currently under evaluation in a Phase 1 study in healthy volunteers in New Zealand evaluating the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses.
- Later this quarter, Pardes anticipates reporting data from this ongoing study at a scientific conference.
- Price Action: PRDS shares are up 6.54% at $11.08 during the market session on the last check Thursday.
