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 discontinued.
"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.
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