Arrowhead files request for regulatory clearance to initiate ARO-DIMER-PA trial

Arrowhead (ARWR) announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-DIMER-PA, the company’s investigational RNA interference therapeutic being developed as a potential treatment for atherosclerotic cardiovascular disease due to mixed hyperlipidemia. ARO-DIMER-PA is designed to silence expression of the proprotein convertase subtilisin kexin 9 and apolipoprotein C3 genes. An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL-C and TGs of a single-dose of ARO-DIMER-PA and multiple doses of ARO-DIMER-PA in up to 78 adult subjects with mixed hyperlipidemia.