06 Jan 2011,Anadys Pharmaceuticals Initiates Phase IIb Study Of ANA598 In HCV Patient

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Anadys Pharmaceuticals Initiates Phase IIb Study Of ANA598 In

HCV Patients

05 Jan 2011

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced that it has

initiated the planned Phase IIb study of ANA598 in combination with

pegylated interferon and ribavirin. The protocol for the study has

been cleared by the United States Food and Drug Administration (FDA)

and Health Canada. Patient screening has begun and patient dosing is

expected to commence within the next several weeks. In the study

ANA598 will be tested in both treatment-naive patients and

treatment-experienced patients who failed a prior course of therapy

with interferon and ribavirin. ANA598 is the Company's direct-acting

antiviral, or DAA, being developed for the treatment of hepatitis C.

"We are excited to initiate this Phase IIb study of ANA598," said

L. Freddo, M.D., Anadys' Senior Vice President, Drug

Development and Chief Medical Officer. "By establishing safety and

efficacy in a greater number of patients, including those who have

failed prior HCV treatment, we hope to position ANA598 as a highly

attractive HCV agent ready for Phase III development."

Phase IIb Protocol Design

In the study, approximately 200 chronically infected genotype 1

hepatitis C patients are expected to receive ANA598 200 mg twice a

day (bid) in combination with Pegasys® (peginterferon alfa-2a) and

Copegus® (ribavirin, USP) (a current standard of care, or SOC) with

a loading dose of 800 mg bid on day 1, while approximately 66

patients are to receive placebo and SOC. Enrollment is expected to

include approximately equal numbers of treatment-naive patients and

patients who have failed a prior course of SOC, including difficult

to treat prior null-responders. The primary endpoint of the study is

Sustained Virological Response 24 weeks after patients conclude all

treatment, known as SVR24. Anadys is conducting the study at sites

within and outside the United States.

Naive Arm

Approximately 100 treatment-naive HCV patients are expected to

receive ANA598 in combination with SOC and 33 treatment-naive HCV

patients are to receive placebo plus SOC. Treatment duration for

naive patients will be response-guided; patients who achieve

undetectable levels of virus at Week 8 and maintain undetectable

levels of virus will be scheduled to conclude all treatment at Week

28. For naive patients with detectable virus at Week 8 dosing with

ANA598, or placebo, and SOC is planned to continue through Week 48.

The Company expects to receive Week 8 antiviral response data by the

end of the second quarter of 2011, Week 12 antiviral response data

in the third quarter of 2011 and Week 24 antiviral response data in

the fourth quarter of 2011.

Treatment-Experienced Arm, Including Prior Null Responders

Approximately 80 patients who were partial responders during, or

relapsers after, a prior course of therapy with SOC alone are

expected to receive ANA598 in combination with SOC, and 33

corresponding patients are to receive placebo plus SOC.

Additionally, approximately 28 prior null responder patients are to

receive ANA598 in combination with SOC. All treatment-experienced

patients who receive ANA598 are scheduled to receive triple

combination therapy for 48 weeks. For the treatment-experienced

patients, the Company expects to receive Week 12 antiviral response

data in the third quarter of 2011 and Week 24 antiviral response

data in the fourth quarter of 2011.

Source: Anadys Pharmaceuticals, Inc

Article URL: http://www.medicalnewstoday.com/articles/212769.php

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Bill Eastman

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