RIDGEFIELD, Conn., April 2, 2011 /PRNewswire/ -- 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.
*Final results of the Phase 2b studies SILEN-C1 and SILEN-C2 for BI 201335 were presented yesterday at the International Liver Congress™ 2011, the 46th Annual Meeting of the European Association for the study of the Liver (EASL) in Berlin.
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.
About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year. Only about 20-45 percent of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is two to five percent per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virologic diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim's own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of U.S. $17.7 billion (12.7 billion euro) while spending 21 percent of net sales in its largest business segment, Prescription Medicines, on research and development.
SOURCE Boehringer Ingelheim