Novartis reports positive top-line data from Phase III trial of cardiovascular drug

22nd June 2017 (Last Updated August 9th, 2019 09:29)

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.

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.

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."

"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).

The 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.