Amgen/Cytokinetics heart drug fails in clinical trial
pharmafile | September 3, 2013 | News story | Research and Development, Sales and Marketing | Amgen, Novartis, cytokinetics, omecamtiv mecarbil
A new heart failure drug by Amgen and Cytokinetics has fallen short of its primary endpoint in a Phase II trial.
The experimental compound omecamtiv mecarbil was administered intravenously among a sample of 613 patients with acute heart failure. However, it failed to significantly reduce shortness of breath – the study’s goal – compared to placebo.
These disappointing results represent a setback for Amgen, which obtained the global rights to omecamtiv mecarbil from Cytokinetics in 2009 – in a deal worth over $100 million in up-front payments alone.
The announcement also comes shortly after Novartis revealed promising Phase III data for its heart failure drug, serelaxin.
Unlike Amgen’s product, serelaxin was found to significantly reduce breathlessness after six months, compared to placebo. It also had a notable impact on mortality over the same period.
Serelaxin was granted ‘breakthrough’ status by the FDA in June and has been tipped by analysts to reach peak sales of $1.5 billion, according to Reuters. The treatment is a form of hormone that helps to reduce pressure on blood vessels and the heart.
Despite the omecamtiv mecarbil trial’s negative outcome, executives at Amgen and Cytokinetics claimed to be ‘encouraged’ by results as higher doses of the drug did appear to elicit some improvement.
Cytokinetics chief executive Robert Blum said that he looks forward to the ‘potential progression’ of omecamtiv mecarbil in development.
He added: “This novel mechanism drug candidate has consistently been associated with dose-related and plasma concentration-related pharmacodynamic and other effects in a robust program of Phase I and Phase II clinical trials”
Heart failure is a condition in which the heart is unable to properly pump blood around the body. It results in breathlessness and lethargy, and is estimated to affect 23 million people worldwide.
Omecamtiv mecarbil functions by activating cardiac myosin, a protein responsible for converting chemical energy into heart muscle contraction.
Researchers will press on with another Phase II trial involving a pill version of omecamtiv mecarbil before deciding whether or not to drop the drug. The study is expected to wrap up by June 2015.
Hugh McCafferty
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