TUESDAY, SEPTEMBER 27, 2016

Arrowhead receives regulatory approval for trial of chronic hepatitis B drug

Arrowhead Research Corporation announced on Monday that it received regulatory approval from the Hong Kong Department of Health to begin Phase 2a clinical trials of hepatitis B virus treatment ARC-520.


The certificate for clinical trial allows a single-dose study of the drug using two cohorts to be conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong. Preparations have begun and researchers will soon begin screening patients.


ARC expects to have initial results from the trial near the end of 2014.


Phase 2a of the clinical trial will involve a double-blind, placebo-controlled, dose-escalation study to determine the effect of a single intravenous dose of ARC-520. Two dose levels will be administered in separate cohorts. Female and male patients between 16 and 65 years of age undergoing entecavir therapy with immune active chronic HBV infection HBV e antigen negativity will be used in the study.


The goal of the study is to determine the efficacy of ARC-520 in combination with entecavir. Other objectives include determining the safety, tolerability and pharmacokinetic measures of ARC-520.


Arrowhead Research Corporation is a biopharmaceutical company that focuses on RNA interference treatments, which kill disease-causing genes. ARC technology is used by partners to develop peptide-drug conjugates that attract to specific cell types. In addition to ARC's hepatitis B clinical programs, the company has partner-based oncology and obesity programs.