Amgen, Cytokinetics' omecamtiv mecarbil misses main goal of Phase II heart failure study

Amgen and Cytokinetics announced Tuesday that a mid-stage trial of the experimental drug omecamtiv mecarbil in patients hospitalised with acute heart failure (AHF) failed to meet its primary endpoint of improving dyspnoea compared to placebo. However the companies said data from the ATOMIC-AHF study, which were presented at the European Society of Cardiology congress, showed "favourable dose and concentration-related trends on dyspnoea response."

The trial randomised 613 patients hospitalised with AHF to receive one of three doses of omecamtiv mecarbil intravenously or placebo for 48 hours. Amgen and Cytokinetics noted that for the main goal, dyspnoea response rates for the three doses of omecamtiv mecarbil were 42 percent, 47 percent and 51 percent, which were not significantly greater than 41 percent seen in the pooled placebo group. However, for the highest dose of omecamtiv mecarbil, the dyspnoea response rate of 51 percent was significantly higher than that seen for its paired placebo group of 37 percent.

Further results showed that the incidence of worsening heart failure within seven days of initiating treatment was 17 percent in the pooled placebo group, compared to 13 percent, 8 percent and 9 percent for the three doses of omecamtiv mecarbil, although the difference was not significant.

"Although ATOMIC-AHF did not achieve its primary efficacy endpoint, we are encouraged by the data," remarked Sean E. Harper, executive vice president of R&D at Amgen. The companies are conducting a second Phase II study, called COSMIC-HF, investigating an oral formulation of omecamtiv mecarbil in patients with chronic heart failure. Harper suggested that the combined results "will inform our decision on whether to progress omecamtiv mecarbil into Phase III clinical trials."

In 2009, Amgen exercised an option to obtain an exclusive global licence, excluding Japan, for Cytokinetics' cardiac myosin activator omecamtiv mecarbil.

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