Pardes Biosciences Announces FDA Clearance of IND Application for Oral Antiviral Drug Candidate for the Treatment & Prevention of SARS-CoV-2 Infections
Pardes Biosciences, Inc. recently announced its Investigational New Drug (IND) application for PBI-0451 has been cleared by the US FDA.
“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, MD, 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 US 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.”
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.
Pardes Biosciences is a clinical-stage biopharmaceutical company created to help solve pandemic-sized problems, starting with COVID-19. We are applying modern reversible-covalent chemistry as a starting point to discover and develop novel oral drug candidates, including our lead product candidate PBI-0451, while reimagining the patient journey to access these medicines. For more information, visit www.pardesbio.com.
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