Arrowhead Research Corp (NASDAQ:ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, said Monday that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ARC-520, its drug candidate for the treatment of chronic hepatitis B virus (HBV) infection.
Once the national regulatory review has been conducted and the company receives approval, it will initiate two Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multi-dose studies to determine the depth of hepatitis B surface antigen (HBsAg) reduction following ARC-520 injection in combination with entecavir or tenofovir in patients with chronic immune active HBV infection. The Heparc-2002 study is planned to include patients who are negative for hepatitis B e-antigen (HBeAg) at screening and the Heparc-2003 study is planned to include patients who are positive for HBeAg at screening.
The primary objective is to evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic HBV infection as a measure of drug activity. Secondary objectives are to assess measures of safety and tolerability and to evaluate multi-dose pharmacokinetics of ARC-520 in patients with chronic HBV infection when co-administered with a fixed dose of entecavir or tenofovir, in addition to other exploratory safety and pharmacodynamic objectives.
The company plans to submit additional clinical trial authorization applications with regulatory authorities in various jurisdictions in Europe and Asia.
Arrowhead Research Corp (NASDAQ:ARWR) shares closed at $5.76, with a 52-week range of $4.95 – $27.63.