Anadys Pharma Restarts trial of chronic hepatitis C treatment

July 10, 2008

7/7/2008 5:32 PM ET

RTTNews) - Clinical-stage biopharmaceutical company Anadys Pharmaceuticals,

Inc. (ANDS: News, Chart, Quote ) Monday said it resumed clinical investigation

of the Toll-Like Receptor-7 mechanism for the treatment of chronic hepatitis C,

based on preclinical pharmacology testing and the results of completed 13-week

GLP animal toxicology studies.

The company has received clearance to initiate a clinical trial of oral TLR7

agonist prodrug ANA773, under a clinical trial application in the Netherlands.

Anadys also continues to enroll patients in a separate Phase I clinical trial of

ANA773 in oncology that is ongoing under an IND in the United States.

San Diego-based Anadys Pharma noted that the results from pre-clinical studies

revealed that ANA773 could obtain desired immune responses and the response

could be modulated by both dose and schedule of administration. A 13-week GLP

toxicology study also showed that with every-other-day dosing of ANA773, immune

stimulation of a magnitude believed to confer therapeutic potential could be

achieved without adverse toxicology findings. ANA773 is an orally administered

prodrug of a novel TLR7-specific agonist.

Steve Worland, President and chief executive officer, said, " Because the ANA773

hepatitis C program is highly leveraged off our oncology program, we expect to

carry forward all three clinical development programs this year within our

previous 2008 cash utilization projection of $29 to $31 million. "

The Phase I clinical trial of ANA773 in HCV will be conducted under a two-part

protocol, with the assessment of safety and tolerability as the primary

objective. The primary objectives of Part B are to assess safety, tolerability

and viral load decline.

Approximately 40 healthy volunteers and 24 patients are expected to be included

in the study. Dosing is expected to begin in healthy volunteers within the next

few weeks and in HCV patients, early in the fourth quarter of 2008.

ANDS closed Monday's regular trading at $2.31, up $0.12 or 5.48%, on a volume of

18,574 shares.

by RTT Staff Writer

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