Pardes Biosciences Inc's PRDS has presented interim data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022.
- The presentation shared details around the nonclinical profile of PBI-0451 and interim clinical safety, tolerability, and pharmacokinetics (PK) after single- and multiple ascending doses.
- PBI-0451 has been generally well tolerated over a >20-fold single- and >14-fold multiple-total daily dose range.
- Related: Pardes Biosciences Clears IND Application For Oral Antiviral Candidate For COVID-19.
- All treatment-emergent adverse events in the study reported through January 31 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.
- In multiple ascending dose cohorts, interim data showed that PBI-0451 twice-daily achieved and maintained PK exposures.
- The Company believes the candidate can provide potent antiviral activity against COVID-19 and emerging variants.
- Additional dose cohorts and PK evaluation in this ongoing Phase 1 study continue.
- The Company will inform dose selection for the upcoming PBI-0451 Phase 2/3 study anticipated to start mid-2022.
- Price Action: PRDS shares are down 1.39% at $12.03 during the market session on the last check Monday.
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