Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced on 2025‑10‑08 that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of its investigational RNAi therapeutic ARO‑DIMER‑PA. The filing, submitted to the New Zealand Medicines and Medical Devices Safety Authority, seeks approval to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and lipid‑lowering effects of a single‑dose and multiple‑dose regimen in up to 78 adult subjects with mixed hyperlipidemia.
ARO‑DIMER‑PA is the first clinical candidate to silence two genes—proprotein convertase subtilisin‑kexin 9 (PCSK9) and apolipoprotein C3 (APOC3)—using Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform. Preclinical studies in dyslipidemic non‑human primates demonstrated potent reductions in serum PCSK9, APOC3, low‑density lipoprotein cholesterol, and triglycerides, supporting the dual‑target approach for addressing residual cardiovascular risk.
The announcement is significant because it marks a strategic expansion of Arrowhead’s cardiometabolic pipeline into a large, high‑value market. Mixed hyperlipidemia affects millions of patients worldwide and represents a major residual risk for atherosclerotic cardiovascular disease. By combining PCSK9 and APOC3 inhibition in a single molecule, ARO‑DIMER‑PA could offer a more comprehensive lipid‑lowering profile than existing monotherapies, potentially positioning Arrowhead for a competitive advantage in a rapidly evolving therapeutic area.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.