Arrowhead Research this week announced that it has received clearance from regulators in Hong Kong to begin a phase IIa trial of its siRNA-based hepatitis B treatment ARC-520.
The single-dose, dose-escalation trial is designed to determine the drug's ability to suppress hepatitis B surface antigen in combination with the oral antiviral agent entecavir in chronic HBV patients.
Single doses of ARC-520 will be evaluated at up to two ascending doses of 1.0 mg/kg and 2.0 mg/kg, Arrowhead said. At each of the two dose levels to be evaluated, a cohort of 8 patients will be enrolled with 6 being dosed with ARC-520 and 2 being dosed with placebo.
With the regulatory approval in hand, Arrowhead said it expects to begin dosing patients "shortly," and that top-line results from the study will be available in the third quarter of the year.