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Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising interim Phase 2a data
Date:11/2/2013

tment. Overall, adverse events have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying faldaprevir and deleobuvir. Benign bilirubin elevation (unconjugated hyperbilirubinemia) has been common in the trial and has occurred in 88% of patients in ribavirin-containing arms, and 46% of patients in the ribavirin-free arm. In the ribavirin-free treatment arm, most adverse events (83%) have been characterized as mild. In the ribavirin-containing arms, adverse events have been mild to moderate.

In March 2013, Boehringer Ingelheim and Presidio Pharmaceuticals entered into a non-exclusive collaboration to evaluate the three DAAs in combination regimens. Both companies will retain all rights to their respective compounds. Presidio has operational responsibility for this collaborative trial, with oversight by an intercompany project team. Final results are expected in Q2 2014.

Additional Boehringer Ingelheim Interferon-Free Data
Also at AASLD, data from Boehringer Ingelheim's interferon-free Phase 2 clinical trial, SOUND-C3 (NCT01132313), are being presented. This study evaluated the investigational compounds, faldaprevir and deleobuvir, with ribavirin in treatment-naive patients with genotype-1b HCV. The results of this study showed that 95% of patients achieved SVR12 after 16 weeks of treatment.

The SOUND-C3 trial was one of Boehringer Ingelheim's first studies evaluating investigational faldaprevir without interferon, in combination with investigational deleobuvir and ribavirin. This study informed the company's current interferon-free development program, including the ongoing clinical collaboration with Presidio Pharmaceuticals.

As part of Boehringer Ingelheim's long-term commitment to an interferon-free future for patients with HCV, the company rece
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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