Novartis has reported positive top-line results from the Phase III CANTOS clinical trial of ACZ885 (canakinumab) and standard-of-care combination to address cardiovascular risk in patients who survived a heart attack.
ACZ885 is a high-affinity, selective, fully human monoclonal antibody currently being developed to inhibit inflammation by blocking the action of a cytokine called IL-1ß.
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The results showed that the drug met the primary endpoint by decreasing cardiovascular risk in people with a history of heart attack and inflammatory atherosclerosis.
Novartis drug development global head and chief medical officer Vas Narasimhan said: "Despite current treatment, about 25% of heart attack survivors will have another cardiovascular event within five years, making the outcome of the CANTOS study a promising new development for patients.
"ACZ885 is the first and only investigational agent that has shown that selectively targeting inflammation reduces cardiovascular risk.”
The randomised, double-blind, placebo-controlled, event-driven Phase III Canakinumab anti-inflammatory thrombosis outcomes study (CANTOS) assessed the efficacy, safety and tolerability of quarterly subcutaneous ACZ885 over six years in 10,061 subjects with previous myocardial infarction (MI).
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By GlobalDataThe trial’s primary endpoint was a decrease in the risk of major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal MI and non-fatal stroke.
Secondary endpoints such as time to first occurrence of the composite CV endpoint, time to new onset type 2 diabetes in patients with pre-diabetes at the time of enrolment, time to occurrence of non-fatal MI, non-fatal stroke or all-cause mortality and time to all-cause mortality were also investigated.
