BI-201335 (Boehringer Ingelheim) Phase III trial completes recruitment

Boehringer Ingelheim has completed recruitment for a late-stage Phase III clinical trial programme for BI-201335, its oral protease inhibitor for the treatment of chronic Hepatitis C virus. The programme, which was awarded a Fast Track designation by the FDA, consists of three studies that will be conducted to evaluate BI-201335 plus the standard treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. The trial's primary endpoint is the assessment of "sustained viral response" (SVR), considered to be a viral cure, with results from the Phase III trials expected in the first half of 2013.