Enrollment complete in Boehringer Ingelheim's BI 201335 Phase III trial for HCV

Boehringer Ingelheim today announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2,000 treatment-experienced as well as treatment-naïve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia.

The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat. The study programme evaluates "sustained viral response" (SVR) as the primary clinical endpoint, which is considered viral cure. Results from the Phase III studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the entire BI 201335 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.

"We are progressing our BI 201335 programme with a high priority to leverage its potential to improve cure rates in HCV treatment," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide."

Phase IIb results presented last month showed that the interferon-free combination of BI 201335, with Boehringer Ingelheim's polymerase inhibitor BI 207127 (SOUND-C2), led to 76% of patients achieving a virological response at week 12, with 63% achieving SVR12 (undetectable virus, 12 weeks post-treatment) with 16 weeks treatment. These results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, alongside SILEN-C1 and SILEN-C3 study results which showed the potential for BI 201335/ PegIFN/RBV to shorten treatment duration and improve the likelihood of viral cure (SVR). These Phase IIb results provide a strong basis for further development as BI 201335 progresses through Phase III.