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Arrowhead initiates phase 2b trial for potential HBV drug in Germany
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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.
The study will last 33 weeks, from screening to the follow-up visit on day 169, according to Arrowhead. For each study, a planning interim analysis will be performed when 54 patients have completed their visit at 71 days. The company will then decide whether higher multiple doses should be evaluated in one or more additional studies.
“ARC-520 is leading the way in studying the use of RNAi drugs as new treatment options for chronic HBV,” Bruce Given, MD, chief operating officer and head of research and development for Arrowhead, said in the release. “We are very pleased to receive regulatory clearance in Europe to conduct the parallel design phase 2b multiple-dose studies that we proposed. We view these studies as the front end of a set of global multiple-dose studies designed to identify the right agents, doses and regimens that can achieve functional cures.”
Arrowhead is currently awaiting approval at multiple clinical sites, according to the release.
Disclosure: Given is employed by Arrowhead.