About Us
About Us
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, we are developing ANA598, a non-nucleoside polymerase inhibitor, and ANA773, an oral TLR7 agonist prodrug. We are also developing ANA773 for the treatment of cancer. Both ANA598 and ANA773 are wholly owned by Anadys and reflect the Company’s expertise with direct antivirals and the TLR7 mechanism.
Hepatitis C
In April 2008, we announced the acceleration of certain non-clinical activities for ANA598 into 2008 in order to enable a more rapid advancement into Phase II trials in 2009. In June 2008, we announced that dosing in healthy volunteers had commenced in a Phase I study of ANA598. Following successful completion of the healthy volunteer study, Anadys plans to initiate a short-term Phase Ib study of ANA598 in HCV-infected patients. Our planned clinical development timelines are structured with the objective that if ANA598 is successful in early stage clinical trials, we expect to be in a position to establish clinical proof of concept (viral load reduction in patients) during the first quarter of 2009.
In July 2008, we announced the expansion of our development efforts in HCV to include clinical investigation of ANA773, our oral Toll-Like Receptor 7 (TLR7) agonist. Based on preclinical pharmacology testing and the results of completed 13-week GLP animal toxicology studies, Anadys received clearance to initiate a clinical trial of ANA773 under a clinical trial application (CTA) in the Netherlands. Following initial dosing in healthy volunteers, this trial will explore every-other-day dosing over 28 days in HCV patients. As an approach to treat hepatitis C, the TLR7 mechanism is independent from, and potentially complementary to, ANA598.
Oncology
In February 2008, we announced that patient dosing had commenced in a Phase I study of ANA773 in oncology in patients with advanced solid tumors. This first-in-human trial is a safety and tolerability study designed to identify pharmacologically active doses and preliminary antitumor activity as well as to select the dose and schedule for Phase II trials.
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