FDA Clears Arrowhead to Continue its Hepatitis B Trial

Pasadena-based Arrowhead Research Corporation announced that US health regulators gave the company the green light to continue with its mid-stage hepatitis B infection study.

The company said that the US Food and Drug Administration (FDA) informed the company that it can proceed with a multiple-dose Phase 2b clinical study of ARC-520, its clinical candidate for the treatment of chronic hepatitis B infection, under an investigational new drug (IND) application previously filed with the agency.

Following the announcement, the biotech’s shares shot up about 16 percent.

The clinical study, known as Heparc-2004, is a placebo-controlled, multi-dose study of ARC-520 administered intravenously to patients with chronic immune active HBV infection maintained on entecavir or tenofovir therapy. The company plans to enroll up to 12 patients who will be randomized at a ratio of 2:1, with 8 patients receiving 1 mg/kg of ARC-520 and 4 patients receiving placebo. Each patient will receive three total doses, once every four weeks. The study’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. Secondary objectives include measuring safety and tolerability and pharmacokinetics of the drug, and to evaluate the effect of ARC-520 on entecavir or tenofovir pharmacokinetics, in addition to other exploratory safety and pharmacodynamic objectives.

In January, the FDA placed a partial clinical hold on the program, requesting Arrowhead provide additional information including data from the single-dose Phase IIa study 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.

“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. 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,” said Bruce Given, MD, chief operating officer and head of R&D for Arrowhead. “We are also working with various regulatory agencies outside of the United States to initiate additional Phase 2b studies.”

ARC-520 is Arrowhead’s RNAi-based candidate. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. The company is testing to see if the drug can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion.

Source: Arrowhead Research Corporation

Last updated: 4/13/15; 10:00am EST



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