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Amgen agrees to take Cytokinetics' heart failure drug into phase III

Phase II results showed significant cardiac function benefit and no adverse safety signals

Amgen has finally decided to push a novel drug candidate for chronic heart failure into a full phase III testing programme.

The move has been prompted by positive results from the phase II COSMIC-HF study of cardiac myosin activator omecamtiv mecarbil, and will come as a relief to the drug's originator, Cytokinetics, which has been waiting for the big biotech to make a decision for several weeks.

Omecamtiv is the first in a new class of drugs designed to increase the duration of cardiac muscle contractility and improve cardiac muscle performance.

It sits among a new generation of heart failure therapies - spearheaded by Novartis' Entresto (sacubitril/valsartan) and Amgen/Servier's Corlanor (ivabradine) - which are trying to advance the treatment of heart failure, something that has been largely static for many years.

Data from the trial in 448 patients with chronic heart failure with reduced ejection fraction (HFrEF) were first reported towards the end of last year and showed significant benefits on cardiac function when omecamtiv mecarbil was given twice-daily over a 20-week period.

The drug was able to improve a number of biomarkers, including systolic ejection time, stroke volume, and N-terminal pro-brain natriuretic peptide (NT-proBNP) compared to placebo, in the study, which started in 2013.

Crucially, no safety signal emerged in the COSMIC-HF study. An earlier trial of omecamtiv mecarbil in acute heart failure - called ATOMIC-AHF - had revealed an increase in myocardial infarction among patients treated with the drug along with an increase in troponin levels (a marker used to diagnose an MI).

There was a small increase in troponin levels in COSMIC-HF but on investigation these were not found to be MIs, according to the investigators.

The data has also encouraged omecamtiv mercabil's European licensee Servier to boost its involvement in the project by also taking rights in Russia and other Commonwealth of Independent States nations. Servier is paying $10m for the option and will also shoulder a share of the development costs of the drug.

Cytokinetics said recently that meetings have been held with both the FDA and EMA to discuss the design of the outcomes study, which is due to start before the end of the year, while phase II studies are ongoing in Japan.

Article by
Phil Taylor

2nd September 2016

From: Research



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