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Amgen drug misses endpoint in acute heart failure trial

Company pledges to pursue development of omecamtiv mecarbil in chronic heart failure

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A drug in development by Amgen and Cytokinetics to treat symptoms of heart failure has missed its primary endpoint in a phase II trial.

During the ATOMIC-AHF trial involving 613 patients with left ventricular systolic dysfunction hospitalised for acute heart failure, an intravenous form of omecamtiv mecarbil was unable to demonstrate it was significantly better than placebo in treating shortness of breath, or dyspnea.

Despite this setback, Amgen said it is yet to give up on the drug completely, noting that the study demonstrated favourable dose and concentration-related trends on dyspnea response in patients treated with omecamtiv mecarbil.

“We are encouraged by the data from this study," said Dr Sean Harper, executive VP of R&D at Amgen, who said further phase II data for an oral formulation of the drug in patients with chronic heart failure was to come from the COSMIC-HF trial.

“We look forward to the data from the COSMIC-HF study, which together with the data from ATOMIC-AHF will inform our decision on whether to progress omecamtiv mecarbil into phase III clinical trials," added Dr Harper.

The disappointing results for the drug in acute heart failure - the sudden or gradual onset of the signs or symptoms of heart failure - mean it's likely further investigation will involve the use of omecamtiv mecarbil in the chronic form of the condition, which is caused by  caused by the heart failing to pump enough blood around the body.

It's a blow for both Amgen and its marketing partner Servier, which obtained from Amgen last month an exclusive option to commercialise omecamtiv mecarbil in Europe. This was part of a deal that involved Amgen obtaining US rights to Servier's chronic heart failure drug Procoralan (ivabradine).

Meanwhile, although there are currently few treatment options for acute heart failure, Novartis' phase III candidate serelaxin is progressing apace. Having recently been granted 'breakthrough' status by the US Food and Drug Administration (FDA), the company has just released promising mortality data that puts it in a position to shortly begin talks with regulators.

Article by
Thomas Meek

3rd September 2013

From: Research



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