- Topline data expected in the first half of 2023
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has reached full planned enrollment of more than 180 participants in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with mixed dyslipidemia. Completion of ARCHES-2 is anticipated around the end 2022 and the company intends to release topline data in the first half of 2023.
Javier San Martin, M.D., chief medical officer at Arrowhead, said: “Arrowhead’s investigational ARO-ANG3 is designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), a liver synthesized inhibitor of lipoprotein lipase and endothelial lipase. ANGPTL3 inhibition has been shown to lower serum and liver triglycerides, serum LDL cholesterol, and has genetic validation as a novel target for cardiovascular disease. The ARCHES-2 clinical study will evaluate safety and efficacy and identify an optimal dose and dosing regimen of ARO-ANG3 to be assessed in future late-stage clinical studies. I want to thank the participating investigators and our entire clinical team for their hard work to enroll this study rapidly and effectively. We look forward to sharing topline data for ARCHES-2 in the first half of 2023.”
ARCHES-2, also called AROANG3-2001 (NCT04832971), is a double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of investigational ARO-ANG3 in adults with mixed dyslipidemia. Three dose levels of ARO-ANG3 (50 mg, 100 mg, and 200 mg) will be evaluated against placebo in participants with mixed dyslipidemia who had the following at screening: (i) low-density lipoprotein cholesterol (LDL-C) greater than or equal to 70 mg/dL (1.8 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL-C) greater than or equal to 100 mg/dL (2.59 mmol/L) and (ii) mean fasting triglycerides (TG) greater than or equal to 150 mg/dL (1.69 mmol/L) but less than or equal to 499 mg/dL (5.61 mmol/L). A total of 182 participants have been enrolled in the study. Up to approximately 20 additional participants that were still in screening when the study reached full enrollment may also be enrolled. All dose cohorts were enrolled in parallel with at least 60 participants per cohort randomly assigned in a 3:1 ratio to receive a subcutaneous injection of ARO-ANG3 or placebo on day 1 and week 12. The duration of the study is approximately 42 weeks from screening to the week 36 end-of-study examination. After completing the week 36 visit, participants will be eligible to continue in an open-label extension period. The primary objective of the ARCHES-2 study is to evaluate the safety and efficacy of ARO-ANG3 in adults with mixed dyslipidemia and select a dosing regimen for later stage clinical studies in this patient population.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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Source: Arrowhead Pharmaceuticals, Inc.
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA