Policy & Regulation
AstraZeneca starts ION449 phase 2b clinical trial
1 December 2020 -

United Kingdom-based AstraZeneca has started a phase 2b clinical trial of ION449 (AZD8233), an investigational antisense medicine intended to decrease blood cholesterol levels in patients with dyslipidemia, it was reported on Monday.

The product is a LIgand Conjugated Antisense medicine being developed in collaboration with United States-based Ionis Pharmaceuticals Inc. It targets proprotein convertase subtilisin/kexin type 9 (PCSK9), an important regulator of low-density lipoprotein cholesterol.

The Phase 2b, randomised, double-blind, placebo-controlled trial is enrolling around 108 participants between the age of 18 to 75 years, who have low-density lipoprotein cholesterol levels between 70 and 190 mg/dL and are receiving moderate- or high-intensity statin therapy as defined by the American College of Cardiology/American Heart Association guidelines on blood cholesterol management. The main aim is to evaluate the effect of different doses of the product on LDL-C compared to placebo at Week 12 in patients taking baseline statin therapy. The study is to assess three dose levels of the product compared to the placebo, all administered once a month by subcutaneous injection. Safety and tolerability will be evaluated along with a number of secondary endpoints.