Benzinga | Jan 25, 2021 07:37AM EST

Arrowhead Pharmaceuticals Files IND For Phase 2b Study Of ARO-ANG3 For Treatment Of Mixed Dyslipidemia

Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2b dose-finding 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: "Cardiovascular disease remains the major cause of death, even after advances in therapies that reduce LDL cholesterol. This highlights the need for new therapies that can help patients at risk for cardiovascular disease to optimize their lipid profiles and protect them from atherosclerosis progression and cardiovascular events. By inhibiting ANGPTL3, Arrowhead's investigational ARO-ANG3 is designed to reduce triglycerides and decrease LDL cholesterol in patients with mixed dyslipidemia. We have been very encouraged by the clinical data from this program to date and look forward to further assessing the safety and efficacy of ARO-ANG3 in the upcoming Phase 2b study."

Following FDA's review of the IND, the company intends to initiate AROANG3-2001, a Phase 2b dose-finding clinical study in patients with elevated triglycerides and low-density lipoprotein cholesterol (LDL-C). The primary objective of the study is to evaluate the safety and efficacy of ARO-ANG3 in adults with mixed dyslipidemia and to select a dosing regimen for later stage clinical studies in this patient population. The study is designed to include a total of 180 participants in three cohorts. All dose cohorts will enroll in parallel, with 60 participants per cohort randomly assigned in a 3:1 ratio to receive ARO-ANG3 or placebo.