FDAnews
www.fdanews.com/articles/82464-ana975-phase-i-clinical-data-to-be-presented-at-meeting

ANA975 PHASE I CLINICAL DATA TO BE PRESENTED AT MEETING

November 15, 2005

Anadys Pharmaceuticals will present results on the pharmacokinetics, pharmacodynamics, safety and tolerability of the isatoribine prodrug ANA975 in a Phase I clinical trial at the annual meeting of the American Association of the Study of Liver Diseases, currently being held in San Francisco. ANA975 is an oral prodrug of isatoribine, a small molecule TLR7 agonist that has been administered intravenously to 68 subjects in clinical trials.

In this open-label, single-dose clinical trial conducted in the UK, 36 healthy volunteers each received a single, oral dose of ANA975 administered as a 5 mg/mL solution in the fasted state at doses of either 400, 800, or 1,200 mg. ANA975 was well-tolerated at all doses investigated in the trial, with no serious adverse events.