Arrowhead initiates phase 2b trial for potential HBV drug
After receiving a clinical hold from the FDA earlier this year, Arrowhead Research Corporation has now been approved by the FDA to begin a multiple-dose phase 2b clinical study of ARC-520 for the treatment of chronic hepatitis B infection, according to a news release from the drug maker.
The clinical study, also known as Heparc-2004, is a randomized, multi-dose study of ARC-520 administered to patients with chronic HBV infection who are receiving Viread (tenofovir disoproxil fumarate, Gilead Sciences) or Baraclude (entecavir, Teva Pharmaceutical Industries) therapy.
Heparc-2004 will include up to 12 patients who will be randomly assigned to receive 1 mg/kg of ARC-520 (n=8) or placebo (n=4). Each patient will receive 3 total doses, once every 4 weeks, according to the release.
“This notification from the FDA allows us to begin a multiple-dose phase 2b study of ARC-520, and we are working diligently to get treatment sites up and running,” Bruce Given, MD, chief operating officer and head of research and development for Arrowhead, said in the release. “Our goal is to gain site IRB approvals and perform site initiation visits to begin recruiting and enrolling patients for this study in about a month. We are also working with various regulatory agencies outside of the United States to initiate additional phase 2b studies.”
In January, the FDA implemented a partial clinical hold on the program requesting additional information, including data from a single-dose phase 2a study in which patients received 1-4 mg/kg of ARC-520.