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Anadys Starts Phase 2b Study of HCV Polymerase Inhibitor ANA598

SUMMARY: Anadys Pharmaceuticals announced this week that it has begun treating the first participants in a Phase 2b clinical trial of its investigational hepatitis C virus (HCV) polymerase inhibitor ANA598. The new drug will be tested in combination with pegylated interferon plus ribavirin in both previously untreated patients and people who did not achieve sustained response to prior therapy.

Below is an edited excerpt from a press release issued by Anadys describing the trial.

Anadys Initiates Dosing in Phase IIb Study of ANA598

San Diego -- January 26, 2011 -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that dosing has begun in the Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin in hepatitis C patients. ANA598, the Company's direct-acting antiviral, is being tested in both treatment-naive patients and patients who failed a prior course of HCV therapy with interferon and ribavirin. Approximately 275 patients are expected to be enrolled in the study. The primary endpoint of the study is Sustained Virological Response 24 weeks after patients complete treatment, known as SVR24.

The company expects to receive Week 8 antiviral response data for treatment-naive patients by the end of the second quarter of 2011, Week 12 antiviral response data for treatment-experienced patients in the third quarter of 2011 and Week 24 antiviral response data for both groups in the fourth quarter of 2011.

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. Anadys is conducting a Phase IIb study of ANA598, the company's DAA, added to current standard of care for the treatment of hepatitis C. The company is also preparing to resume clinical development of ANA773, the company's oral, small-molecule inducer of endogenous interferons that acts via the Toll like receptor 7, or TLR7, pathway in hepatitis C.

2/1/11

Source
Anadys Pharmaceuticals. Anadys Initiates Dosing in Phase IIb Study of ANA598. Press release. January 26, 2011.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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