Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-ANG3

Arrowhead Pharmaceuticals (NASDAQ:ARWR) today announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias and metabolic diseases.

As quoted in the press release:

Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals, said: “The ARO-ANG3 program has moved rapidly through preclinical development and we are thrilled to now submit the regulatory filing ahead of schedule. After positive initial signs of tolerability and activity with ARO-AAT and ARO-HBV, our first two clinical programs leveraging the TRiM™ platform, we are moving into the ARO-ANG3 clinical program with confidence.”

Pending approval, Arrowhead intends to proceed with AROANG1001, a Phase 1 single and multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of ARO-ANG3 in adult healthy volunteers and dyslipidemic patients. The study is designed to enroll up to 70 subjects.

An application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.

Click here to read the full press release.