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Enanta Announces Positive Phase 2 Results From Interferon-Free Combination Studies with ABT-450 for Hepatitis C Treatment to be Presented at EASL
Date:4/4/2012

interferon-free, all-oral regimens for previously treated and treatment-naive patients with HCV," said Jay Luly, Ph.D., President and CEO of Enanta.  "Enanta's involvement in five distinct HCV drug classes provides multiple avenues to pursue our goal of bringing to patients innovative therapies that are safer and more effective than current treatments."

Oral Presentations

Oral Presentation, Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 10:00 am - 12:00 pm EDT.
A 12-week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naive HCV IL28B-CC Genotype-1-Infected Subjects

  • The objectives of the 12-week, phase 2 study were to assess the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.
  • The study was conducted in 11 treatment naive adults from multiple ethnic backgrounds with non-cirrhotic HCV GT1 (8 GT 1a, 3 GT 1b). Ribavirin 1000-1200 mg/day was weight-based and dosed twice daily.
  • The primary endpoint was percentage of patients with HCV RNA <25 IU/ml from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.
  • 100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks 4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment.
  • 91 percent of patients achieved SVR24,
  • In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations.

Late-Breaking Oral Presentation, Fred Poordad, et al.; Saturday, April 21, 15:30-17:
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SOURCE Enanta Pharmaceuticals, Inc.
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