Boehringer Begins Phase 3 Trial for Hep C Drug

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RIDGEFIELD — Boehringer Ingelheim Pharmaceuticals has announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The U.S. Food and Drug Administration (FDA) has granted “fast track designation for the development program for BI 201335. 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 pleased to have begun enrolling patients at North American trial sites as we continue development of BI 201335," said Peter Piliero, MD, executive director of medical affairs for Boehringer Ingelheim. "We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV coinfected patients, as we continue to advance our HCV portfolio."

There are currently three Phase 3 trials enrolling patients around the world that together seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that together plan to enroll approximately 495 patients.
 
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