| AMSTERDAM, Sept 3
AMSTERDAM, Sept 3 An experimental heart failure
drug from Amgen and Cytokinetics missed its
goal of improving shortness of breath in a mid-stage clinical
trial, leaving its future uncertain.
Despite the setback in the 613-patient trial using an
intravenous formulation of the medicine omecamtiv mecarbil in
hospitals, Amgen said it would continue testing an oral version
of the drug in a separate Phase II study.
The combined results from the tests will determine whether
the medicine advances into final Phase III testing or is
"We are going to look at all the data very, very carefully
before making a decision around the future of the molecule,"
said Scott Wasserman, Amgen's executive medical director.
Heart failure, in which heart muscle is unable to pump
enough blood around the body, is an often deadly disease. About
half of people diagnosed with the condition die within five
years and treatments have changed little since the 1970s.
Omecamtiv mecarbil, which Amgen licensed from Cytokinetics,
takes a novel approach to tackling heart failure by activating
cardiac myosin, a protein in heart cells that is responsible for
converting chemical energy into muscle contraction.
The data from the intravenous drug study were unveiled on
Tuesday at the European Society of Cardiology congress in
Amsterdam, where the difficulty of developing new drugs to treat
heart failure has been a major talking point among doctors.
Dr. Christopher Grainger of Duke University Medical Center,
who was not involved in the research, said results from the
trial were disappointing, even though there were some
encouraging trends towards a favourable response.
"I would be discouraged by this in terms of the implications
for the drug having an important effect," he said, noting there
had been better results with another product from Novartis
But Dr. Mariell Jessup, president of the American Heart
Association and a specialist in heart failure, said it would be
premature to dismiss the Amgen drug, noting it was very
difficult to show efficacy in a hospital setting.
"There is still hope. Even if you can't show efficacy in the
acute setting, as long as there is not an adverse signal I think
it is worthwhile studying the oral equivalent," she said.
U.S. biotech giant Amgen has traditionally focused on
oncology but more recently has diversified into cardiology,
where it is also in a race to develop a new class of
cholesterol-lowering drugs known as PCSK9 inhibitors.
In July, it also clinched a deal to secure commercial rights
to a drug from French drugmaker Servier for chronic heart
failure and angina.