Anadys Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) to begin drug trials for a new combination compound to treat hepatitis C.
The FDA approval is based on a finalised protocol for the company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients.
Allowance of the protocol has been received from the FDA, and patient dosing is expected to commence within a few weeks.
The primary endpoint of the study is the proportion of patients with undetectable virus at week 12. Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week four, weeks 24 and 48, and 24 weeks after stopping all treatment
Anadys president and CEO Steve Worland said that ANA598 had demonstrated potent antiviral activity and good tolerability as a single agent in Phase I, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens.
"We are now in a position to demonstrate the value of ANA598 when used in combination in a Phase II trial to treat hepatitis C patients," Worland said.
The study is set to enrol 90 patients – 30 patients receiving ANA598 and 15 receiving placebo at each dose level.
In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) twice daily for 12 weeks.
After week 12, patients will continue to receive standard of care. Patients who achieve undetectable levels of the virus at weeks four and 12 will be randomised to stop all treatment at week 24 or 48.
Anadys expects to receive 28-day safety and response data from the 200mg dose level by the end of 2009 and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.