Boehringer Ingelheim to commence 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.

The company has provided an outline for the forthcoming placebo-controlled studies, which will evaluate the once-daily oral protease inhibitor in combination with pegylated-interferon and ribavirin, the current standard of care.

Trials will be conducted among both treatment-naive and treatment-experienced patients, with the primary efficacy endpoint being sustained viral response against the chronic genotype-1 hepatitis C virus.

It comes in the same week that Boehringer Ingelheim was granted fast track designation by the US Food and Drug Administration for approval of the new treatment.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "We are committed to bringing BI 201335 forward, with the ambition of improving cure rates for the benefit of those living with hepatitis C."

Last month, the company published clinical data that highlighted the benefits of Spiriva, an inhalation-based treatment for chronic obstructive pulmonary disease.