Boehringer to Move Ahead Phase III Trial of Hepatitis C Drug

Boehringer Ingelheim has announced plans to move ahead with phase III clinical trials of its new hepatitis C treatment BI 201335.

Boehringer Ingelheim has announced its study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-na?ve and -experienced patients with chronic genotype-1 hepatitis C virus (HCV), the most challenging genotype to treat.

In parallel, the U.S. 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 pat