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Arrowhead gets FDA clearance to begin Phase IIb trial of ARC-520 to treat chronic HBV

The US Food and Drug Administration (FDA) has granted clearance for Arrowhead Research's (ARWR) investigational new drug (IND) application to proceed with a multiple-dose Phase IIb clinical trial of ARC-520, its clinical candidate to treat chronic hepatitis B virus (HBV) infection.

In the multicenter, randomized, double-blind, placebo-controlled, multi-dose trial (Heparc-2004), ARC-520 will be administered intravenously to patients with chronic immune active HBV infection maintained on entecavir or tenofovir therapy.

Around 12 patients will be enrolled in the trial and they will be randomized at a ratio of 2:1 with eight patients receiving 1mg/kg of ARC-520 and four patients receiving placebo.

Each patient will receive three total doses, once every four weeks, while patients will be followed through Day 147.

Arrowhead chief operating officer and head of R&D Bruce Given said: "This notification from the FDA allows us to begin a multiple-dose Phase IIb study of ARC-520, and we are working diligently to get treatment sites up and running.

"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 IIb studies."

The trial’s primary objective is to evaluate the depth of hepatitis B surface antigen (HBsAg) decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic, immune active HBV infection as a measure of drug activity.

Secondary objectives of the trial are to measure safety and tolerability and pharmacokinetics of ARC-520, as well as to evaluate the effect of ARC-520 on entecavir or tenofovir pharmacokinetics, in addition to other exploratory safety and pharmacodynamic objectives.

In connection with an IND filed last December, the company proposed a parallel design multiple-dose Phase IIb trial testing doses of 2mg/kg and 4mg/kg simultaneously.

In January 2015, the FDA notified the company that a partial clinical hold had been placed on the program.

To proceed with the proposed parallel design trial, the FDA requested that the company to provide additional information including data from the single-dose Phase IIa trial in patients who receive 1-4 mg/kg ARC-520, data from an ongoing multiple-dose non-clinical study, and data from Heparc-2004 which is now cleared to begin.