Benzinga | Jun 30, 2021 07:35AM EDT

Arrowhead Pharmaceuticals Initiates Phase 2b Study of Investigational ARO-ANG3 for Treatment of Mixed Dyslipidemia

Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that it has dosed the first patient in AROANG3-2001, a Phase 2b clinical study of ARO-ANG3, the company's investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with mixed dyslipidemia.

Javier San Martin, M.D., chief medical officer at Arrowhead, said: "By inhibiting ANGPTL3, Arrowhead's investigational ARO-ANG3 is designed to reduce triglycerides and LDL cholesterol in patients with mixed dyslipidemia. Patients with persistently elevated triglycerides and LDL cholesterol may have a higher risk of atherosclerosis progression and cardiovascular events, which are major causes of death. The Phase 2b AROANG3-2001 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."

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 499 mg/dL (5.61 mmol/L). A total of approximately 180 participants will be enrolled in the study. All dose cohorts will enroll in parallel with 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 study. The primary objective of the AROANG3-2001 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.