Cytokinetics, Amgen drug
shows promise in heart failure study
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[November 09, 2015]
By Bill Berkrot
ORLANDO (Reuters) - An experimental heart
failure drug being developed by Cytokinetics Inc and Amgen Inc
demonstrated several beneficial cardiac function effects in a midstage
clinical trial, according to data presented on Sunday.
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The trial of 448 patients with chronic heart failure already
receiving optimal care tested a twice-a-day oral version of the
drug, omecamtiv mecarbil, against a placebo over 20 weeks. After two
weeks of treatment, a group of patients had the drug dose doubled to
50 milligrams from 25 mg.
Statistically significant improvements were seen in those patients
compared to those taking a placebo, including increased volume and
percentage of blood pumped with each heartbeat, a reduction in heart
rate and a decrease in the size of the heart, known as remodeling.
As heart failure progresses and the heart has to work harder to pump
blood it tends to become enlarged, so size reduction is viewed as an
important effect in potentially slowing disease progression.
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There was also a significant reduction in a biomarker associated
with heart disease known as NT-proBNP in patients who received the
drug, researchers said.
"The magnitude of cardiac effects observed are impressive. These may
translate into improvements in long-term cardiac outcomes," said Dr.
John Teerlink, who presented the data at the American Heart
Association scientific meeting in Orlando.
Rates of serious adverse events, including deaths, heart attacks and
chest pain, were similar for the drug and placebo groups,
researchers said.
Heart failure, in which the heart becomes unable to pump enough
blood, affects more than 23 million people worldwide and is the
leading cause of hospitalization and readmissions in people 65 and
older.
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Teerlink, from the University of California, San Francisco, said
finding an agent that provides improved cardiac function in heart
failure patients "is the Holy Grail," adding that we're not there
yet.
Larger trials are needed to evaluate the true safety and
effectiveness of omecamtiv mecarbil, he said.
Cytokinetics, which discovered the drug, said it and Amgen will
analyze the data from this and previous studies before making a
decision to move into much larger Phase III trials that would be
used to seek regulatory approval.
(Reporting by Bill Berkrot; Editing by Andrea Ricci)
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