GlobeImmune initiates Phase II hepatitis C trial

The Phase II clinical trial is a randomized, open-label, multi-arm, 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.

Endpoints will include improvement in alanine aminotransferase (ALT) levels, early virologic response (EVR), end of treatment response (ETR), sustained virologic response (SVR), serum markers of liver fibrosis or necrosis and liver biopsy in a subset of patients. This study is designed to enroll 120 patients randomized 1:1 in the two arms at approximately 50 centers in the US, India and Europe.

GI-5005 is GlobeImmune’s lead infectious disease product for the treatment of chronic hepatitis C infection from the company’s proprietary Tarmogen active immunotherapy platform. It is being evaluated as a potential therapy in combination with standard of care, pegylated interferon plus ribavirin.

David Apelian, chief medical officer of GlobeImmune, said: “With the initiation of this trial, we continue to make excellent progress in advancing our GI-5005 development program.”