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Boehringer Ingelheim today announced the study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus (HCV), the most challenging genotype to treat.
In parallel, the U.S. Food and Drug Administration (FDA) has granted Fast Track designations for BI 201335 plus standard-of care (SOC), and as part of the interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.
“We are delighted to receive the FDA’s Fast Track designation for both, our BI 201335 plus SOC, and interferon-free combination treatment approaches. If successful, the combination therapy carries the potential for patients to live without the burden of interferon’s side effects,” 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 cure rates for the benefit of those living with hepatitis C.”
BI 201335 Phase III Trials
BI 201335 will be evaluated in multiple randomised, double-blind, placebo-controlled trials in combination with pegylated-interferon and ribavirin (PegIFN/RBV), the current HCV SOC. The Phase III trials include two studies in treatment- naïve and one study in treatment-experienced chronic genotype-1 HCV patients. The two studies in treatment-naïve patients will be conducted in the European Union and Japan, as well as the U.S., Canada, Taiwan and Korea. The study in treatment-experienced patients will be conducted globally. BI 201335 will be dosed once-daily at either 120mg or 240mg in combination with PegIFN/RBV and treatment durations will range from 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 III trial programme expected to commence in the second quarter of 2011.
PegIFN-Free Phase II Trials of BI 201335 + BI 207127
In parallel, Boehringer Ingelheim is developing BI 207127, an oral HCV polymerase inhibitor that has completed Phase I clinical trials in combination with BI 201335. Phase II trials evaluating BI 207127 plus BI 201335 in PegIFN-free regimens, both with and without ribavirin, are currently underway. The FDA has designated this investigation as a Fast Track development programme. 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.