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Arrowhead Begins Dosing the Phase 2b MONARCH Combination Study of ARC-520 in Patients with Chronic Hepatitis B Infection

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, dosed the first patient in the Phase 2b MONARCH combination study of ARC-520, it’s RNAi-based drug for the treatment of chronic hepatitis B virus (HBV) infection. The clinical trial is currently enrolling patients at multiple centers in Australia and New Zealand. MONARCH is intended to identify one or more combinations of ARC-520 and other therapeutic agents that can potentially lead to a functional cure of chronic HBV.

Arrowhead Research initiates Phase 2b study of ARC-520 its #RNAi drug for chronic #hepatitis B

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“We recently reported clinical data from our Phase 2a study at AASLD showing that a single dose of ARC-520 can achieve a reduction of up to 99% in hepatitis B surface antigen, and nonclinical data at HepDART showing that multiple doses of ARC-520 were associated with immune reactivation in 7 of 9 chimpanzees studied. These data make us very eager to see results as they emerge from MONARCH and our other multiple dose studies,” said Christopher Anzalone, Ph.D., Arrowhead president and CEO. “The goal of MONARCH is to identify one or more combinations of ARC-520 and other agents that enable functional cures in patients. If we can achieve this, it would represent a big leap forward in the field and provide hope for the more than 350 million people worldwide chronically infected with the hepatitis B virus.”

The MONARCH study, also called Heparc-2008, is a multicenter, open-label study to evaluate ARC-520 administered alone and in combination with other therapeutics in patients with chronic hepatitis B virus infection. The primary outcome measure is the percentage of patients achieving a 1-log reduction in hepatitis B surface antigen (HBsAg) compared to baseline. Secondary outcome measures include the percentage of patients achieving HBsAg loss and time to...