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Abbott and Enanta Present Positive Initial Results from Phase 2 Study of ABT-450/r for Treatment of Hepatitis C
Date:11/1/2010

Center at Cedars-Sinai Medical Center in Los Angeles, and one of the investigators for the study.  "The initial results of ABT-450/r in patients with HCV suggest that ABT-450/r has favorable potency in the most common HCV genotype and that ABT-450/r could be an important element in a combination direct-acting antiviral regimen for treatment of HCV."

"Abbott has focused its antiviral research expertise on finding new treatment options for HCV-infected patients that could transform current therapy – by shortening the duration of treatment and increasing cure rates," said Scott Brun, M.D., divisional vice president, infectious disease development, Abbott.  "We continue to explore the potential for use of ABT-450/r in a variety of combination regimens."

"We are very encouraged by the 3-day monotherapy and 4-week rapid virologic response results for ABT-450 and we look forward to further clinical results from the program," said Jay Luly, Ph.D, president and chief executive officer, Enanta Pharmaceuticals.  "This data is an important step in our HCV program, and for advancing our broader vision to improve patient care in this field."

Study Objectives and DesignThe objectives of the 48-week Phase 2 study are to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple dose strengths of ABT-450/r in treatment-naïve adults infected with HCV genotype 1, which is the most common and difficult to treat form of the infection in the developed world.  Trial endpoints include early virologic response and rapid virologic response.  Initial antiviral activity was evaluated via a 3-day treatment period during which ABT-450/r was administered alone. Subsequently, ABT-450/r was administered with pegIFN/RBV (SOC) for 12 weeks, followed by treatment with SOC alone for an additional 36 weeks.  Participants are then monitored post therapy for 24 weeks for sustained virologic response.

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