Pharmasset Initiates Phase-1b Clinical Trial For Hepatitis-C Drug

Pharmasset has announced the completion of the single ascending dose study, and has begun dosing in a multiple ascending dose trial with PSI-7851. Its a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The study is designed to assess the safety, tolerability and antiviral activity of PSI-7851 over 3 days in HCV-infected individuals.

A Phase 1b multiple ascending dose trial has now been initiated in patients with chronic HCV genotype 1 infection. Subjects will be enrolled at multiple centers and randomized to PSI-7851 or placebo. Based upon the results from the SAD study, the first dose of PSI-7851 to be tested will be a daily dose of 50mg.

Michelle Berrey, CMO of Pharmasset, said: We are encouraged by the safety and pharmacokinetics of PSI-7851 thus far,We believe PSI-7851, Pharmasset’s lead second generation nucleotide, has the potential to be administered once a day at low milligram doses, while also continuing to demonstrate the many benefits nucleos(t)ides have over other classes of HCV direct acting antivirals, including a high barrier to resistance, pan-genotype potency, and ability to combine with other classes of compounds.