Guest guest Posted April 3, 2011 Report Share Posted April 3, 2011 This drug is currently in clinical trial in San Francisco--and accepting patients. Sure looks promising for geno 1. Imagine clearing Hep C in two weeks--don't know how long it holds clearance or if one must continue drug. But it is definitely hopeful news. Presidio Pharmaceuticals has completed a randomised, double-blind, placebo-controlled PPI-461 Phase 1a clinical trial in healthy subjects. 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. iel 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.†Quinn In the swamp in secluded recesses, a shy and hidden bird is warbling a song. Walt Whitman Quote Link to comment Share on other sites More sharing options...
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