The Phase 3 trials include two studies in treatment-naive and one study in treatment-experienced chronic genotype-1 HCV patients.
Boehringer Ingelheim expects to conduct the two Phase 3 studies in the European Union, Japan, the US, Canada, Taiwan and Korea.
The study in treatment-experienced patients will be conducted in the European Union, US, Canada and Japan.
The company has received the US Food and Drug Administration’s (FDA) fast track designation for the development programs for BI 201335 in combination with pegylated interferon and ribavirin and as part of an interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said they are delighted to receive the FDA’s fast track designation for their two development programs evaluating BI 201335 plus current standard-of-care and BI 201335 plus BI 207127 in an interferon-free combination treatment approach.