Pardes Biosciences Presents Interim Clinical Data From Ongoing PBI-0451 Phase 1 Trial 

Pardes Biosciences, Inc. recently announced interim clinical data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers has been made available to registered conference attendees at the 29th Conference on Retroviruses and Opportunistic Infections (CROI) 2022. The presentation, titled PBI-0451: An Orally Administered 3CL Protease Inhibitor of SARS-CoV-2 for COVID-19, shared details around the nonclinical profile of PBI-0451 as well as interim clinical safety, tolerability, and pharmacokinetics (PK) after single- and multiple-ascending doses.

“We are highly encouraged by these initial Phase 1 observations, which support continued development of PBI-0451 as a potential stand-alone antiviral therapy for the treatment and prevention of SARS-CoV-2 infections,” said Uri A. Lopatin, MD, Chief Executive Officer. “COVID-19 continues to take the lives of over 2,000 people a day in the US alone and disrupts healthcare globally. Additional treatment options with the potential to treat current and emerging variants, such as protease inhibitors, continue to be needed. We are excited to continue advancing our lead protease inhibitor PBI-0451 and bring our novel oral antiviral treatment one step closer to patients in need.”

In the ongoing first in human Phase I trial, PBI-0451 has been observed to be generally well tolerated over a >20-fold single- and >14-fold multiple-total daily dose range. All treatment emergent adverse events in the study reported through January 31, 2022, have been assessed as mild in severity and resolved without intervention.

In a drug-drug interaction cohort, the pharmacokinetics of PBI-0451 was not substantially affected when co-administered with ritonavir, a potent P-glycoprotein/CYP450 3A inhibitor.

In multiple ascending dose cohorts, interim data showed that PBI-0451 twice-daily (BID; 2 x 350 mg tablets) achieved and maintained PK exposures that the company believes has the potential to provide potent antiviral activity against SARS-CoV-2 and emerging variants.  Additional dose cohorts and PK evaluation in this ongoing Phase 1 study continues and will inform dose selection for the upcoming PBI-0451 Phase 2/3 study anticipated to start mid 2022 (pending regulatory interactions) to evaluate PBI-0451 as a potential treatment of SARS-CoV-2.

PBI-0451, the company’s lead product candidate, is an investigational orally bioavailable direct-acting antiviral (DAA) inhibitor of the 3CL protease also called 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 conserved across all known coronaviruses, including emerging coronavirus variants. PBI-0451 is being developed for the treatment and prevention of SARS-CoV-2 infection and associated diseases (ie, COVID-19). PBI-0451 is currently under evaluation in an ongoing Phase 1 placebo-controlled, blinded, randomized, dose escalation study in healthy adult 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. For more information, visit www.pardesbio.com.