Anadys Pharmaceuticals has announced the start of Phase II trials of ANA598, a new treatment for patients chronically infected with hepatitis C virus (HCV).
The study will evaluate ANA598, which has been granted fast track status by the US Food and Drug Administration (FDA), over 12 weeks in treatment-naive HCV patients.
ANA598 is an investigational oral non-nucleoside polymerase inhibitor that will be tested in combination with pegylated interferon-alpha and ribavirin.
Anadys’ senior vice-president of drug development and chief medical officer James Freddo said that ANA598 has demonstrated potent antiviral activity and good tolerability as a single agent.
“The drug has also shown preclinical properties indicative of likely synergy when used clinically in combination regimens,” said James Freddo.
Ninety patients will be enrolled in the study, for which the primary endpoint is the proportion of patients with undetectable virus at week 12.
The study will be managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, MD and will be conducted at a number of clinical sites in the US.