Dr Yves Horsmans, Professor at Cliniques Universitaires St Luc in Brussels and principal investigator of the study commented. “These results create strong interest in clinical evaluation of ANA975, the oral prodrug form of isatoribine that now is being jointly developed by Anadys and Novartis.”
The phase Ib clinical trial was designed to test the safety and tolerability of isatoribine in patients chronically infected with hepatitis C virus. The study was a dose-escalating, open-label evaluation of isatoribine administered intravenously at 200mg, 400mg, 600mg and 800mg doses to 32 adults, most of whom received once daily dosing for seven days.
Isatoribine treatment was safe and well tolerated in the study, with no serious adverse events and a low frequency of side effects; although definitive conclusions regarding product safety cannot be made until the results of future clinical trials of longer duration in more patients are known
Hepatitis C virus, the most common chronic blood-borne infection in the US, causes inflammation of the liver and may progress to more serious complications such as cirrhosis of the liver, liver cancer and death.