Arrowhead Research Files Application To Begin Phase 2a Trial Of ARC-520

(RTTNews) - Arrowhead Research Corp. (ARWR) announced Monday that it recently filed an application for approval to begin a phase 2a clinical trial of its RNAi-based therapeutic candidate, ARC-520, for the potential treatment of chronic hepatitis B virus infection.

Pending approval, the company said it plans to proceed with a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study. The study is being conducted to determine the depth and duration of hepatitis B surface antigen (HBsAg) reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection. Additional details on study design and anticipated timelines will be provided when patient enrollment begins.

An application for a Certificate for Clinical Trial was submitted to the Hong Kong Department of Health, and the study protocol, investigator brochure, and informed consent were submitted to the ethics committees at two sites in Hong Kong. Hong Kong was chosen as the location for the study based on the high prevalence of chronic HBV infection and for the advanced healthcare and regulatory system, the company noted.