The placebo-controlled, randomized trial is a parallel-group dose-response study of the ability of ITX5061 to reduce viral load in treatment-naive and previously treated patients with hepatitis C virus (HCV) infection, when ITX5061 is administered as a single agent.
The Phase IIa study will enroll approximately 40 patients at three centers in Europe. Primary endpoints for the study will be efficacy as measured by reduction in viral load. Safety and pharmacokinetics will also be assessed.
Jeffrey McKelvy, CEO of iTherX, said: “This molecule has exhibited a good safety profile in preclinical studies and in previous clinical studies involving over 250 subjects. Our Phase IIa study represents a clinical efficacy study for a small molecule HCV entry inhibitor.
“We look forward to carrying out further clinical studies to demonstrate the value of ITX5061 in the treatment of this serious illness, which is poorly treated with current therapy.”