Positive phase 2 results for Boehringer Ingelheim’s hepatitis C drug

Hannah Blake

pharmaphorum

Boehringer Ingelheim is to begin phase 3 clinical trials of its hepatitis C drug following promising phase 2 trial results.

The clinical trials evaluated Boehringer’s highly effective polymodal therapy, faldaprevir (BI 201335), which is a potent next wave once daily protease inhibitor, and BI 207127, a potent non-nucleoside polymerase inhibitor, plus ribavirin.

Final results from the phase 2b study, SOUND-C2, when looking at all patients collectively, confirmed that 69% of hepatitis C (HCV) patients achieved and sustained viral cure when measured 12 and 24 weeks after treatment. This was compared with an 85% viral cure rate seen in the prevalent GT-1b patient subgroup and a 67% viral cure rate in the 9% of total trial population who had liver cirrhosis (severe scarring of the liver), an advanced form of liver disease.

"Eliminating interferon-alfa is a critical goal in hepatitis C. These Phase IIb results bring us a step closer to an interferon-free anti-HCV treatment for many patients. We included a broad spectrum of patients in SOUND-C2, reflecting those that we see day-to-day in our clinics, including patients with cirrhosis, who desperately need an effective alternative treatment option to interferon-based therapies."

Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Goethe University Hospital in Frankfurt, Germany.

Boehringer’s studies were the largest interferon-free trials of its kind to be conducted to date. Following the positive mid-stage trial results, the global pharmaceutical company plans to move forward with its phase 3 all-oral interferon-free HCV regimen shortly.

"Based on the high viral cure rates seen in the Phase IIb studies for our novel hepatitis C compounds faldaprevir and BI 207127, we are optimistic in being able to deliver new treatment options in response to the high unmet medical need in HCV. We are proud to announce the initiation of our robust Phase III interferon-free trial programme in HCV. We continue to pursue our goal of delivering an all-oral, highly effective polymodal therapy without interferon, to provide more hepatitis C patients with a viral cure, following a shorter treatment, and reduce harsh side-effects."

Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.

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