Date: 2011-12-09
Type of information:
phase: 3
Announcement: randomisation of the final patient
Company: Boehringer Ingelheim (Germany)
Product: BI 201335
Action mechanism: BI 201335 is an oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).
Disease: chronic hepatitis C virus
Therapeutic area: Infectious diseases
Country: Europe, Japan, USA, Canada, Taiwan, Korea and Russia
Trial
details: 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.
Latest
news: Boehringer Ingelheim has announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335. 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 59% 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. Results from the Phase III studies are expected in the first half of 2013. The FDA has granted Fast Track designation for the entire BI 201335 programme.
