The Phase II clinical trial is a randomized, open-label, multi-center trial evaluating GI-5005 in combination with full duration standard of care, versus standard of care alone in patients with chronic genotype 1 hepatitis C infection who are either treatment-naive or non-responders to previous therapy. GI-5005 is being evaluated as a potential therapy in combination with standard of care; pegylated interferon plus ribavirin.
Endpoints for the trial include improvement in early virologic response, HCV RNA kinetics, alanine aminotransferase (ALT) levels, the primary biochemical marker of liver damage, end of treatment response, sustained virologic response, serum markers of liver fibrosis or necrosis, and liver biopsy. This study has enrolled the planned target of 120 patients in five months at 40 centers in the US, India and Europe.
GI-5005 is GlobeImmune’s infectious disease product candidate for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets.