Arrowhead Pharmaceuticals Initiates Phase 2b Study of Investigational ARO-ANG3 for Treatment of Mixed Dyslipidemia
- Category: DNA RNA and Cells
- Published on Thursday, 01 July 2021 10:38
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PASADENA, CA, USA I June 30, 2021 I 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.
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