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www.fdanews.com/articles/88669-anadys-starts-new-preclinical-study-after-suspended-phase-i-trial

ANADYS STARTS NEW PRECLINICAL STUDY AFTER SUSPENDED PHASE I TRIAL

November 8, 2006

Anadys Pharmaceuticals has initiated, in collaboration with Novartis, a 13-week preclinical toxicology study of ANA975 to assess safety and tolerability in animals. The study, which uses a new crystalline form of ANA975, should further the understanding of the toxicology profile of ANA975, according to Anadys.

"The Anadys and Novartis joint development team has been working diligently over the summer to gain a better understanding of what occurred in the initial 13-week toxicology study in animals," Steve Worland, president of Anadys, said.

In June Anadys suspended dosing of ANA975 in its Phase Ib trial in patients with chronic hepatitis C pending additional analysis of recently obtained information from preclinical 13-week toxicology studies in animals. Preliminary analysis of that information revealed various new observations, which appear consistent with intense immune stimulation in animals. Subsequently, the ANA975 investigational new drug application was put on full clinical hold by the FDA. There have been no serious adverse events in humans during the Phase Ib trial.

ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary Toll-Like Receptor-7 (TLR7) agonist. TLR-7 is a receptor that activates the innate immune system. Activation of innate immunity is known to be an important component of the human immune defense. ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials and to 14 hepatitis C patients prior to the suspension of the Phase Ib trial without serious adverse events.