5th Apr 2022 07:00
(Alliance News) - AstraZeneca PLC announced positive results from its Etesian phase IIb trial on Monday, which met its primary and secondary endpoints.
The Cambridge, England-based pharmaceutical company said its investigational antisense oligonucleotide, AZD8233, met the primary endpoint of reducing low-density lipoprotein cholesterol from baseline. LDL levels were reduced by 73% at a 50-milligram dose from baseline levels.
AZD8233 is administered once a month subcutaneously. For the Etesian trial, three doses were evaluated at 15mg, 50mg and 90mg, in patients with high-risk hypercholesterolemia - those with elevated LDL-C levels - on a high-dose statin.
"More than half of patients with cardiovascular disease at high-risk of a major secondary event do not meet their LDL-C goals, despite taking a high-intensity statin. Elevated LDL-C is a key risk factor for cardiovascular disease," AZ explained.
AZD8233 proved generally well tolerated for the duration.
The trials also met its secondary endpoint of reducing proprotein convertase subtilisin/kexin type 9 levels. Reducing PCSK9 increases LDL receptor levels, which lowers LDL-C in the bloodstream, reducing the risk of developing coronary heart disease. PCSK9 levels were reduced by 89% at a 50mg dose.
"Today, we are pleased to announce that Etesian phase IIb for AZD8233 demonstrated a clear dose-response for both PCSK9 and LDL-C levels. The results underscore AZD8233's potential best-in-class efficacy profile, and supports its further development as a next generation PCSK9 inhibitor that is easily self-administered monthly," said Executive Vice President of BioPharmaceuticals Research & Development Mene Pangalos.
AZ shares closed up 0.7% to 10,142.00 pence each in London on Monday.
Results from the Solano Phase IIb trial assessing the safety, efficacy and tolerability of AZD8233 in hypercholesterolemia patients are expected later this year.
By Elizabeth Winter; [email protected]
Copyright 2022 Alliance News Limited. All Rights Reserved.