Pardes Biosciences has reported preliminary results from the ongoing Phase I clinical trials with its oral antiviral drug candidate, PBI-0451, in healthy adult subjects.
A direct-acting antiviral (DAA) inhibitor of the 3CL protease, PBI-0451, is under development to treat and prevent Covid-19 and associated disorders.
The drug is currently being analyzed in a placebo-controlled, blinded, randomized, dose-escalating phase I trial in New Zealand.
It enrolled healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of single and multiple increasing doses of the antiviral agent.
Preliminary findings showed that PBI-0451 was shown to be well tolerated over a> 20-fold single and> 14-fold multiple-total daily dose.
In the trial, all treatment-emergent side effects reported until 31 January 2022 were observed to be mild and disappeared without requiring intervention.
The pharmacokinetics of PBI-0451 in a drug-interaction arm were not significantly affected when co-administered with ritonavir, an inhibitor of P-glycoprotein / CYP450 3A.
Furthermore, a dose of PBI-0451 obtained and maintained twice daily PK exposures in several increasing dose arms.
Pardes noted that this indicates the potential of the drug to offer robust antiviral activity against the SARS-CoV-2 virus as well as its new variants.
Additional dose cohorts and PK analysis in the trial are currently underway, which will help with the selection of the dose for the upcoming Phase II / III trial with PBI-0451.
The company plans to begin Phase II / III studies this year to obtain regulatory approval to evaluate PBI-0451 for the treatment of Covid-19.
Parde Biosciences CEO Uri Lopatin said: “We are very encouraged by these initial Phase I observations, which support the continued development of PBI-0451 as a potential independent antiviral therapy for the treatment and prevention of SARS-CoV-2 infections.
“We are excited to continue to promote our leading protease inhibitor PBI-0451 and bring our new oral antiviral therapy one step closer to patients in need.”
The latest developments are coming after The US Food and Drug Administration has given approval to Pardes’ Investigational New Drug Application for PBI-0451 for Covid-19 Treatment and Prevention.