Arrowhead Gets Regulatory Ok To Begin Phase 2a Clinical Trial Of ARC-520

(RTTNews) - Biopharmaceutical company Arrowhead Research Corp. (ARWR) said it received regulatory approval to begin a Phase 2a clinical trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus or HBV infection.

The Hong Kong Department of Health issued a Certificate for Clinical Trial, allowing the company to proceed with its planned single-dose study of ARC-520 in two cohorts at two dose levels to be conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong.

A site initiation was completed and patient screening will begin shortly. The company expects top line study results to be available in the third quarter of 2014.

The Phase 2a study is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to determine the depth and duration of hepatitis B surface antigen or HbsAg reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection.

The primary objective of the study is to evaluate the depth and duration of HBsAg decline in response to a single dose of ARC-520 in combination with entecavir.

Secondary objectives include evaluation of safety and tolerability and pharmacokinetic measures.