PPI-461 is Presidio Pharma’s lead HCV NS5A inhibitor. The trial evaluated four single doses of PPI-461, followed by a five-day, once-a-day treatment regimen with PPI-461 at the highest tested dose.
The results of the trial suggested that PPI-461 was well-tolerated in all dose regimens. In the five-day, multi-dose regimen, steady-state Pharmacokinetic (PK) was readily achieved, supportive of once-daily dosing.
PK analyses showed substantial blood levels of PPI-461 were rapidly and consistently achieved and were dose proportional.
Currently, Presidio Pharma is planning to initiate a Phase 1b proof-of-concept trial in patients with HCV in Q4 2010 and expects to have early results regarding the clinical efficacy of PPI-461 near year-end.
Nathaniel Brown, chief medical officer, said: “These first clinical data of PPI-461 indicate excellent tolerance in healthy subjects with all tested dosing regimens. The PK profile is very encouraging, suggesting that plasma concentrations of PPI-461 can be obtained with a relatively low dose, once-daily (QD) regimen that may provide a continuous antiviral effect.”