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Monday, January 7, 2019

Arrowhead files for regulatory clearance to begin ARO-APOC3 Phase 1 study


Arrowhead Pharmaceuticals announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-APOC3, an RNAi-based investigational medicine targeting Apolipoprotein C-III being developed for the treatment of hypertriglyceridemia. Pending approval, Arrowhead intends to proceed with AROAPOC31001, a Phase 1 single and multiple dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ARO-APOC3 in adult healthy volunteers, hypertriglyceridemic patients, and patients with familial chylomicronemia syndrome. The study is designed to enroll up to 63 subjects.

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