Amgen and Cytokinetics Announce Positive Top-Line Results From COSMIC-HF, A Phase 2 Trial of Omecamtiv Mecarbil in Patients With Chronic Heart Failure

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Amgen and Cytokinetics Incorporated today announced that data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in HeartFailure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization. The pharmacodynamic effects of omecamtiv mecarbil were generally dose dependent. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.

The expansion phase of COSMIC-HF was designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Data from the expansion phase showed that pharmacokinetic-based dose titration adequately controlled patient exposure to omecamtiv mecarbil and resulted in statistically significant decreases in cardiac dimensions and heart rate in the dose-titration group.  

Adverse events, including serious adverse events, in patients on omecamtiv mecarbil appeared comparable to those on placebo. A small increase in troponin was seen among subjects receiving omecamtiv mecarbil. Events of increased troponin were independently adjudicated and none were determined to be myocardial ischemia or infarction. There was no imbalance in deaths, and cardiac adverse events were generally balanced between placebo and active treatment groups.

The full trial results will be submitted to a future medical conference and for publication.

"The positive results from the COSMIC-HF trial of omecamtiv mecarbil are encouraging," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are committed to working with Cytokinetics to better understand the data and its potential role in the treatment of heart failure patients."

"We are pleased that this Phase 2 trial of omecamtiv mecarbil met the objectives related to safety, tolerability, pharmacokinetics and pharmacodynamics in a population of chronic heart failure patients," said Robert I. Blum, president and CEO at Cytokinetics. "Omecamtiv mecarbil has the potential to offer a new treatment option for patients with heart failure; we look forward to working with Amgen and the medical community to better understand the potential clinical application of this novel drug candidate."

Heart failure is a common condition that affects more than 23 million people worldwide,^3,4 about half of whom have reduced left ventricular function.⁵ It is the leading cause of hospitalization and readmission in people age 65 and older. Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor. An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.

Source: Omecamtiv Mecarbil