Cytokinetics Announces Start Of GALACTIC-HF, A Phase 3 Clinical Trial Of Omecamtiv Mecarbil

Trial to be Conducted Under Special Protocol Assessment with the FDA

Company Earns $26.7 Million Milestone Payment from Amgen

SOUTH SAN FRANCISCO, Calif., Dec. 01, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the activation of the first clinical site and the start of GALACTIC-HF ( G lobal A pproach to L owering A dverse C ardiac Outcomes T hrough I mproving C ontractility in H eart F ailure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics. Coincident with the start of the trial, Amgen will make a $26.7 million milestone payment to Cytokinetics. In clinical studies, omecamtiv mecarbil, a novel investigational cardiac myosin activator, has been shown to enhance cardiac function by increasing cardiac contractility and is being developed for the potential treatment of patients with chronic heart failure.

The primary objective of this double-blind, randomized, placebo-controlled multicenter clinical trial is to determine if treatment with omecamtiv mecarbil when added to standard of care is superior to standard of care plus placebo in reducing the risk of cardiovascular death or heart failure events in patients with high risk chronic heart failure and reduced ejection fraction. GALACTIC-HF will be conducted under a Special Protocol Assessment (SPA) with the U.S. FDA.

"We are pleased that GALACTIC-HF is underway and we are grateful for the participation of investigators and their staff at the many hundreds of clinical sites worldwide who will be managing the care of the chronic heart failure patients in this pivotal trial," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "We will look forward to the results of this Phase 3 trial which is designed to assess whether the increases in cardiac function observed in prior trials of omecamtiv mecarbil will translate into improved cardiovascular outcomes for patients living with chronic heart failure."

GALACTIC-HF: Trial Design

GALACTIC-HF is planned to enroll approximately 8,000 symptomatic chronic heart failure patients in over 800 sites in 34 countries who are either currently hospitalized for a primary reason of heart failure or have had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. In order to be eligible to participate in GALACTIC-HF patients should have an LVEF = 35%, be NYHA class II to IV, and have an elevated BNP or NT-proBNP. Patients will be randomized to either placebo or omecamtiv mecarbil with dose titration up to a maximum dose of 50 mg twice daily based on the plasma concentration of omecamtiv mecarbil after initiation of drug therapy. The primary endpoint is a composite of time to cardiovascular death or first heart failure event, which is defined as either a hospitalization for heart failure or other urgent treatment for worsening heart failure. Secondary endpoints include time to cardiovascular death; patient reported outcomes as measured by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score; time to first heart failure hospitalization; and all-cause death. For additional information, please visit http://bit.ly/2fC2wtp.

About Heart Failure

Heart failure is a grievous condition that affects more than 23 million people worldwide, about half of whom have reduced left ventricular function. 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.

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