Arrowhead submits FDA application for hep B treatment

Arrowhead Research Corporation, a biopharmaceutical company specializing in creating targeted RNAi therapies, recently submitted an application to the U.S. Food and Drug Administration (FDA) for further testing of a new drug, called ARC-520, to treat chronic hepatitis B virus infection.

Arrowhead is seeking authorization to begin Phase 2b randomized double-blind placebo-controlled multi-dose studies in multiple locations. The studies will determine how much reduction of hepatitis B surface antigens will occur after doses of ARC-520, entecavir and tenofovir. Scientists also want to determine the safety of the treatments.

Researchers will use pharmacodynamic objectives and exploratory safety to uncover results. They will also implement a placebo to learn the efficacy of the HBV infection.

Subjects will include patients who test negative for hepatitis B e-antigen (HBeAg) as well as others who test positive for HBeAg.

The FDA application “represents achievement of a key 2014 goal,” Dr. Christopher Arnzalon, CEO and president of Arrowhead Research Corporation, said. “We look forward to beginning multi-dose studies with ARC-520.”

Arrowhead announced that it plans to submit similar applications to gain approval for clinical trials in its other jurisdictions, including Asia and Europe.

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