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Novartis’ heart drug canakinumab meets primary endpoint in phase III study

PBR Staff Writer Published 23 June 2017

Novartis’ heart drug ACZ885 (canakinumab) has met primary endpoint in the global phase III Canakinumab anti-inflammatory thrombosis outcomes (Cantos) study.

The topline results from the trial have showed that the drug in combination with standard of care ACZ885 reduces the risk of major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in patients with a prior heart attack and inflammatory atherosclerosis.

ACZ885 is a selective, high-affinity and fully human monoclonal antibody that inhibits IL-1ß, which is a crucial cytokine in the inflammatory pathway that will enhance the continued progression of inflammatory atherosclerosis.

It is said to work by blocking the action of IL-1ß for a sustained period of time, enabling to inhibit inflammation that is caused by its over-production.

Cantos is claimed to be one the largest and longest-running clinical trials in the company’s history with more than 10,000 patients recruited in the study over the last six years.

The study was designed to assess the efficacy, safety and tolerability of quarterly subcutaneous injections of ACZ885 in combination with standard of care in the prevention of recurrent cardiovascular (CV) events among 10,061 people with a prior myocardial infarction (MI) and with a high-sensitivity C-reactive protein (hsCRP) level of >=2mg/L.

According to the company, ACZ885 is the first and only agent that demonstrated to selectively target inflammation to significantly reduce cardiovascular risk in patients who have had a prior heart attack and have an increased cardiovascular inflammatory burden.

The firm also produces Entresto (sacubitril/valsartan), which was given a Class I recommendation in US and European Union clinical guidelines to treat heart failure with reduced ejection fraction (HFrEF).

Novartis chief medical officer and drug development head 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.”

Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.