Clinical-stage biopharmaceutical company Anadys Pharmaceuticals, Inc. (ANDS) 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.
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