Amgen has reported a favourable cognitive function outcome from Phase III EBBINGHAUS clinical trial of Repatha (evolocumab) being developed to minimise low-density lipoprotein (LDL) levels.
Repatha is a human monoclonal antibody designed to inhibit binding of proprotein convertase subtilisin / kexin type 9 (PCSK9) to LDL receptor.
Results showed that the use of Repatha to lower LDL-C did not impair cognition, and it was non-inferior to placebo without significant difference in cognitive function.
The double-blind, placebo-controlled, randomised non-inferiority EBBINGHAUS trial assessed the effect of Repatha on a cognitive function of 1,974 clinically evident atherosclerotic cardiovascular disease patients enrolled in the drug candidate’s previous FOURIER trial conducted in 27,564 subjects.
Amgen Research and Development executive vice-president Sean Harper said: "Across our comprehensive clinical trial programme, thousands of patients have been treated with Repatha, which has demonstrated a consistent safety profile, even at very low LDL cholesterol levels.
“These findings add to the body of evidence supporting the safety of LDL-lowering with Repatha in patients with established cardiovascular disease who need more than statin therapy alone."
Repatha demonstrated non-inferiority to placebo for the primary endpoint of executive function in the primary cohort of 1,204 subjects who were followed for a median of 19 months.
In the case of the secondary endpoints, including working memory, memory function and psychomotor speed, no statistical difference was observed between the drug candidate and placebo.
During an exploratory analysis, the results were found to be consistent irrespective of the LDL-C levels achieved and did not demonstrate an association between LDL-C level and adverse cognitive outcomes.
The neurocognitive adverse event rates were found to be similar for Repatha and placebo, and the events were consistent with those in the FOURIER trial.
Image: Amgen headquarters in California, US. Photo: courtesy of Coolcaesar.