Amgen, Cytokinetics heart failure drug misses goal in study

AMSTERDAM, Sept 3 Tue Sep 3, 2013 2:00am EDT

AMSTERDAM, Sept 3 (Reuters) - 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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Comments (1)
AvrahamShM wrote:
The statement in the 4th paragraph that there are no new treatment options for heart failure is quite misleading. There are no new *approved* options. However, there is at least one outstanding option that is already in a very large trial in the U.S., and which I believe will become the standard of care for decades to come, and possibly longer if gene therapy proves difficult to implement vis a vis timely repair of the heart. The product in question is Sunshine Heart’s (SSH) C-Pulse heart valve sleeve. Not only is this the only such device that doesn’t contact the blood stream (and hence almost no chance of infection), but it is the only device that has shown the ability to completely heal damaged heart tissue and thus to allow permanent weaning. Moreover, the company is already well on the way to creating a completely implantable version, with no external leads for charging batteries (actually, even the current version can be detached for many hours a day, unless conventional LVADs, etc.). The huge advantace of SSH’s C-Pulse is that it doesn’t do the work of the heart, but rather gets the heart to do its own work by simply adding a little extra squeezing power. This is why several patients have already been weaned, because their hearts basically got the break they needed, while still being exercised. No device does anything like this.

Full disclosure: I own SSH stock. But I’m not trying to go for a temporary uptick in price. Rather, I’m holding SSH until either the company gets sold or the C-Pulse comes to market, whichever comes first. I may even hold longer than that depending on the post-sale/marketing situation. The C-Pulse is the kind of product that can win its inventor (already very successful, BTW) a Nobel Prize in medicine. If you think I’m exaggerating, surf Seeking Alpha or Google in general for articles and interviews with C-Pulse users. There are plenty, and they’re quite convincing. It should also be noted that the company, though valued at only about $100m, is in excellent financial health. Pardon the pun, but I whole-heartedly recommend Sunshine Heart to fellow investors.

Sep 03, 2013 2:43am EDT  --  Report as abuse
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