Arrowhead Research Corporation received regulatory clearance to begin a
multiple-dose phase 2b clinical study of ARC-520 for the treatment of
chronic hepatitis B infection in Germany, after the Federal Institute
for Drugs and Medical Devices approved its clinical trial application,
according to a news release from the drug maker.
With the clearance, Arrowhead will conduct two
phase 2b multiple-dose studies of ARC-520, Heparc-2002 and Heparc-2003,
in parallel of one another, according to the release. The studies will
include patients with chronic HBV
infection that are hepatitis B e-antigen (HBeAg)-negative and HBeAg
positive, who will be evaluated at two dose levels in parallel of
ARC-520 in combination with Baraclude (entecavir, Teva Pharmaceutical
Industries) or Viread (tenofovir disoproxil fumarate, Gilead Sciences).
The release also states that the studies will
enroll up to 60 and 90 patients and be randomly assigned to receive four
doses, once every 4 weeks, of either 1 mg/kg ARC-520, 2 mg/kg ARC-520 or placebo.
Labels: ARC-520 Phase 2b, Arrowhead