US-based late-stage biopharmaceutical company Cytokinetics has initiated its Phase III GALACTIC-HF clinical trial of omecamtiv mecarbil to treat patients experiencing chronic heart failure.
Developed by Amgen in collaboration with Cytokinetics, omecamtiv mecarbil is a cardiac myosin activator believed to expedite rate-limiting of the myosin enzymatic cycle and shift the enzymatic cycle in favour of the force-producing state.
Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell, responsible for converting chemical energy into the mechanical force and resulting in cardiac contraction.
The Phase III global approach to lowering adverse cardiac outcomes through improving contractility in heart failure (GALACTIC-HF) trial is a double-blind, randomised, placebo-controlled multicentre clinical study.
It is designed to establish the superiority of omecamtiv mecarbil when added to standard of care against placebo and standard of care in reducing risk of cardiovascular death or heart failure events in patients with high risk chronic heart failure and reduced ejection fraction.
The study is planning to involve about 8,000 symptomatic chronic heart failure patients who are either currently hospitalised or had a history of hospitalisation for heart failure within one year prior to screening.
The study is primarily aimed at determining the composite of time to cardiovascular death or first heart failure event.
The secondary endpoints of the study are to determine time to cardiovascular death, patient reported outcomes as measured by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, time to first heart failure hospitalisation and all-cause death.
Cytokinetics president and CEO Robert Blum said: “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.
“We will look forward to the results of this Phase III 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.”