Anadys suspends dosing in hepatitis C trial pending assessment of preclinical toxicology studies

By E. Janene Geiss

Philadelphia, June 26 - Anadys Pharmaceuticals, Inc. said Monday that it has suspended dosing hepatitis C virus patients in its ongoing phase 1b clinical trial with ANA975 pending additional analysis of recently obtained information from preclinical 13-week toxicology studies in animals.

Preliminary analysis of this information revealed various new observations that appear consistent with intense immune stimulation in animals, according to a company news release.

Anadys and its collaborator, pharmaceutical company Novartis, are evaluating these observations to determine future course of action.

"Although we have not seen any serious adverse events in clinical experience with ANA975, the health and safety of patients are our first and overriding concern," Kleanthis G. Xanthopoulos, Anadys' president and chief executive officer, said in the release.

The trial suspension is a precaution while the new information is understood, Xanthopoulos added.

ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary Toll-Like Receptor-7 (TLR7) agonist. TLR7 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 1 trials.

Anadys is a San Diego biopharmaceutical company.

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