Boehringer Ingelheim has completed recruitment for a late-stage clinical trial programme for BI 201335, its oral protease inhibitor for the treatment of chronic hepatitis C virus.
The programme consists of three Phase III studies that will be conducted to evaluate BI 201335 plus the standard treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Boehringer notes that "sustained viral response” is the primary clinical endpoint, which is considered a cure, and results are expected in the first half of 2013.
Klaus Dugi, head of medicine at Boehringer, said BI 201335, a once-daily compound, is being progressed "with a high priority to leverage its potential to improve cure rates in HCV treatment”. He added that "our HCV pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide".
The US Food and Drug Administration has granted fast-track designation for the BI 201335 programme, which is underway at more than 350 sites in 15 countries. It includes nearly 2,000 patients.