This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Amgen, Cytokinetics Report Mixed Results for Heart Failure Drug

AMSTERDAM ( TheStreet) -- An experimental heart failure drug from Amgen (AMGN) and Cytokinetics (CYTK) failed to significantly improve shortness of breath in hospitalized patients, according to results from a mid-stage study announced Tuesday.

But heart failure patients treated with the highest dose of the drug, known as omecamtiv mecarbil, were able to breathe easier and showed sufficient, additional clinical improvements for Amgen and Cytokinetics to call the overall study outcome "encouraging."

The companies are waiting for results from a second mid-stage study of omecamtiv mecarbil expected early next year before deciding whether to invest considerable time and money to conduct phase III studies in heart failure patients.

Cytokinetics shares are down 25 percent to $7.84 in early Tuesday trading. Amgen shares are up 1% to $111.04.

The current mid-stage study, known as ATOMIC-AHF, enrolled 613 patients hospitalized with acute heart failure -- a serious and life-threatening condition in which the weakened muscles of the heart are unable to pump blood properly. Patients in the study were randomized to one of three doses of omecamtiv mecarbil given intravenously or a matching placebo injection over 48 hours.

Episodes of dypsnea, or shortness of breath, often force heart failure patients to be admitted to the hospital, so the main goal of the ATOMIC-AHF study was to determine if omecamtiv mecarbil could improve dypsnea response compared to placebo.

The dyspnea response rates were 42 percent, 47 percent and 51 percent in the low, middle and high dose omecamtiv mecarbil patient groups, compared to 41 percent in the pooled placebo group. The difference, while favoring omecamtiv mecarbil, was not statistically significant, so the primary endpoint of the study was not met.

The negative result, while disappointing, was not surprising necessarily. Amgen and Cytokinetics had been warning investors not to expect a statistically significant improvement in overall dypsnea response because the lowest dose of omecamtiv mecarbil tested was thought to be sub-therapeutic. Instead, the companies hoped to show improvements in dyspnea response that correlated with higher blood levels of omecamtiv mecarbil.

Improvement in dypsnea was reported at the highest omecamtiv mecarbil dose compared to its paired placebo -- 51 percent vs. 37 percent. Amgen and Cytokinetics said this difference was statistically significant.

An improvement in dypsnea will not be enough to get omecamtiv mecarbil approved in the U.S. or Europe. For approval, the drug will need to improve survival or significantly lower hospital re-admission rates in heart failure patients. Amgen and Cytokinetics incorporated some of these clinical endpoints in the ATOMIC-AHF study but with mixed-to-disappointing results.

The incidence of worsening heart failure within seven days of initiating treatment was 17 percent in the pooled placebo group compared to 13 percent, 8 percent and 9 percent in the low, middle and high doses of omecamtiv mecarbil, respectively. The difference, while trending favorably in the drug's direction, was not statistically significant.

There was almost no change in the median length of hospital stay for patients in the study. Placebo patients were hospitalized for a median of eight days, the same as patients treated with the highest dose of omecamtiv mecarbil. Patients treated with the low and middle dose of the drug were in the hospital for a median of eight and seven days, respectively.

Days alive out of hospital through day 30 in the pooled placebo group was 22 days, compared with 23 days for the low and middle doses of omecamtiv mecarbil and 22 days for the high dose.

Eighteen patients died during the study -- 10 treated with placebo and eight treated with omecamtiv mecarbil. (One death in the low dose, four in the middle dose and three in the high dose.)

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,131.97 +100.83 0.59%
S&P 500 1,998.98 +14.85 0.75%
NASDAQ 4,552.7590 +33.8570 0.75%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs