According to the company, preliminary analyses of information from the 13-week toxicology studies in animals have revealed various new observations which appear consistent with intense immune stimulation in animals. Anadys and Novartis are now said to be in the process of evaluating these observations in order to determine the 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,” said Dr Kleanthis Xanthopoulos, Anadys' president and CEO. “Consequently, we are suspending this trial for appropriate reasons of precaution while we gain a greater understanding of this recently obtained information.”
“We continue to believe that ANA975 is an effective immunomodulator and therefore a potentially promising agent for patients infected with hepatitis C virus, and look forward to working with Novartis to continue the program,” continued Dr Xanthopoulos.