Boehringer Ingelheim advances into Phase 3 clinical trial of BI 201335

Boehringer Ingelheim today announced a preview of the study designs for the pivotal Phase 3 clinical trials evaluating BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus (HCV), the most challenging genotype to treat.

The U.S. Food and Drug Administration (FDA) has granted 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. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

"We are delighted to receive the FDA's Fast Track designation for our two development programs evaluating BI 201335 plus current standard-of-care and BI 201335 plus BI 207127 in an interferon-free combination treatment approach," said Professor Klaus Dugi, corporate senior vice president medicine at Boehringer Ingelheim. "We are committed to bringing BI 201335 forward, with the ambition of improving treatment for patients living with hepatitis C."

BI 201335 Phase 3 Trials

BI 201335 will be evaluated in multiple randomized, double-blind, placebo-controlled trials in combination with pegylated-interferon and ribavirin (PegIFN/RBV), the current HCV standard-of-care (SOC). The Phase 3 trials include two studies in treatment-naive and one study in treatment-experienced chronic genotype-1 HCV patients. The two studies in treatment-naive patients will be conducted in the European Union, Japan, the U.S., Canada, Taiwan and Korea. The study in treatment-experienced patients will be conducted in the European Union, U.S., Canada and Japan. BI 201335 will be dosed once-daily at either 120mg or 240mg for 12 to 24 weeks, in combination with PegIFN/RBV for 24 to 48 weeks. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure. These studies are part of a broader Phase 3 trial program expected to commence in the second quarter of 2011.

PegIFN-Free Phase 2 Trials of BI 201335 + BI 207127

In parallel, Boehringer Ingelheim is developing BI 207127, an oral HCV polymerase inhibitor that has completed Phase 1 clinical trials in combination with BI 201335. Phase 2 trials evaluating BI 207127 plus BI 201335 in PegIFN-free regimens, both with and without ribavirin, are currently underway.