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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.
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