Arrowhead Launches Phase 1/2a Trial for Novel ASCVD Therapy
Arrowhead Pharmaceuticals has announced plans to initiate a Phase 1/2a clinical trial of ARO-DIMER-PA, a novel RNA interference therapeutic designed to treat atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia. This disorder is characterized by high levels of LDL-C and triglycerides, posing a significant risk factor for ASCVD.
ARO-DIMER-PA is the first clinical candidate to target two genes simultaneously using Arrowhead's TRiM platform. It is designed to selectively silence the expression of PCSK9 and APOC3 genes with a single RNAi molecule, using the company's proprietary TRiM technology. Preclinical studies in nonhuman primates have shown promising results, demonstrating the potential to lower serum PCSK9 and APOC3, and improve high levels of non-HDL-cholesterol, LDL-cholesterol, and triglycerides in dyslipidemic animals.
Despite effective LDL-C-lowering therapies, there remains a substantial residual risk in patients with mixed hyperlipidemia. The Phase 1/2a clinical trial of ARO-DIMER-PA will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL-C and TGs in up to 78 adult subjects with mixed hyperlipidemia. This trial follows the presentation of preclinical data at the National Lipid Association (NLA) 2025 Annual Scientific Sessions.
Arrowhead Pharmaceuticals, a company specializing in developing medicines that treat intractable diseases by silencing the genes that cause them, has filed for regulatory clearance to commence the Phase 1/2a clinical trial of ARO-DIMER-PA. If successful, this dual-functional RNAi molecule could offer a new approach to managing ASCVD risk in patients with mixed hyperlipidemia.
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