Amgen, Cytokinetics report positive mid-stage data for omecamtiv mecarbil in chronic heart failure

Results from a Phase II study indicated that Amgen and Cytokinetics' experimental drug omecamtiv mecarbil showed significant improvements in several measures of cardiac function in patients with chronic heart failure. The improvements included systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomisation. "The positive results...are encouraging," commented Sean E. Harper, executive vice president of R&D at Amgen, adding "we are committed to working with Cytokinetics to better understand the data and its potential role in the treatment of heart failure patients."

In the study, which was the expansion phase of the COSMIC-HF study, 448 patients with chronic heart failure and left ventricular systolic dysfunction were randomised to treatment with an oral formulation of omecamtiv mecarbil twice daily or placebo for 20 weeks and followed for 24 weeks. The primary endpoints of the study were to assess the maximum and pre-dose plasma concentrations of omecamtiv mecarbil, while secondary endpoints included changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide levels at 20 weeks, in addition to safety and tolerability measures including the incidence of adverse events from baseline to week 24.

The drugmakers noted that the incidence of adverse events, including serious adverse events, was similar across the treatment arms. Treatment with omecamtiv mecarbil was linked to a small elevation of troponin, although no events after independent adjudication were determined to be myocardial ischaemia or infarction. Death rates were not imbalanced across the study groups, while cardiac adverse events were similar between the groups.

"We anticipate a decision to move to Phase III in the next few months," noted Cytokinetics CEO Robert Blum, adding "a potential Phase III study would be in the range of 3000-5000 patients, enrolling patients at high risk of death and readmission."

In 2009, Amgen exercised an option to obtain an exclusive global licence, excluding Japan, for omecamtiv mecarbil and related compounds. In 2013, Amgen and Cytokinetics announced that a mid-stage trial of an intravenous formulation of omecamtiv mecarbil in patients hospitalised with acute heart failure failed to meet its primary endpoint of improving dyspnoea compared to placebo.

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