Arrowhead seeks approval to start ARC-520 phase 2a trial for chronic hepatitis B infection

Nov 25 2013

Arrowhead Research Corporation (NASDAQ:ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced 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, Arrowhead intends 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, which has a history of successful participation in clinical trials for antiviral agents.

Principal investigators Professor Man-Fung Yuen, Chief of Gastroenterology and Hepatology at The University of Hong Kong, Queen Mary Hospital, and Professor Henry LY Chan, Head of Gastroenterology and Hepatology at The Chinese University of Hong Kong, Prince of Wales Hospital, will conduct the study. These investigators and sites were selected based on their large pool of patients currently under care, their international standing as HBV researchers, and track record of high accrual rates for clinical trials involving viral hepatitis.