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Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2 Study of ARC-521


Arrowhead Pharmaceuticals, Inc. (ARWR), recently filed a regulatory submission in New Zealand to begin a Phase 1/2 clinical trial of ARC-521, its RNAi-based therapeutic candidate for the treatment of chronic hepatitis B virus (HBV) infection. Pending approval, Arrowhead intends to proceed with ARC521-1001, a first-in-human study to assess single and multiple-doses of ARC-521 in healthy volunteers and HBV patients.

Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals, said: “ARC-521 is our second pipeline product targeting chronic HBV and was designed to silence gene products from both HBV cccDNA and integrated HBV DNA. This is important because our clinical work with ARC-520 in HBV patients and our long-term chimpanzee study suggest that different patient groups can have different relative levels of cccDNA. We think having both ARC-520, which has been very active in patients with higher cccDNA, and ARC-521, which may be optimal for those with lower cccDNA, should provide us with the potential to treat all patients with HBV. We have an aggressive plan for the development of ARC-521 that includes an accelerated first-in-man Phase 1/2 design intended to allow rapid transition into multi-dose patient cohorts.”

The application for approval of a clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for review by the Standing Committee on Therapeutic Trials (SCOTT). Arrowhead also intends to seek regulatory clearance to conduct ARC521-1001 in additional countries.

About ARC-521