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Over 50 clinical trials with a single focus:Improve lives

Clinical Trials

The safety, tolerability, pharmacokinetics, and pharmacodynamics of omecamtiv mecarbil have been studied across eleven Phase 1 clinical trials, which enrolled over 300 healthy subjects. In addition, seven Phase 2 clinical trials have enrolled more than 1,400 people with heart failure. Omecamtiv mecarbil is currently the subject of a Phase 3 clinical trials program. Recent trials include:

METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) – METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. This trial is being conducted by Cytokinetics in collaboration with Amgen and Servier, and is designed to enroll approximately 270 patients with HFrEF at sites throughout the U.S., Canada and Europe. For more information about this trial, click here.
GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) – GALACTIC-HF is a Phase 3, double-blind, placebo-controlled, multicenter clinical trial to be conducted by Amgen in collaboration with Cytokinetics. The trial is evaluating the effect of treatment with omecamtiv mecarbil compared with placebo in approximately 8,200 patients with chronic heart failure with reduced ejection fraction receiving standard of care therapy.The primary endpoint is time to cardiovascular death or first heart failure event, whichever comes first. GALACTIC-HF is being conducted under a Special Protocol Assessment (SPA) with the FDA. For more information about this trial, click here.
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) – Cytokinetics and Amgen announced results from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating oral omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, at the American Heart Association Scientific Sessions in November 2015. COSMIC-HF was a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to evaluate the pharmacokinetics and tolerability of orally-administered omecamtiv mecarbil in approximately 450 patients.
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) – Cytokinetics and Amgen announced results from ATOMIC-AHF (A Trial of Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure), a Phase 2b trial evaluating omecamtiv mecarbil in acutely ill, hospitalized heart failure patients, at the European Society of Cardiology (ESC) Congress and the Heart Failure Society of America (HFSA) Annual Meeting, both in September 2013. This clinical trial was an international, multicenter, randomized, double-blind, placebo-controlled study in approximately 600 patients, enrolled in three sequential, ascending-dose cohorts. In each cohort, patients were randomized to receive omecamtiv mecarbil or placebo.

CK-274 was the subject of a Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose study which demonstrated that it was safe and well tolerated in healthy participants. For more information about the trial, click here.

REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) – REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose-finding clinical trial in patients with symptomatic, obstructive HCM (oHCM). The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response and dose-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment. Additionally, the trial will evaluate the plasma concentrations of CK-274 in patients with oHCM in relationship to dose. Exploratory objectives include the effect of CK-274 on N‑terminal prohormone of brain natriuretic peptide (NT‑proBNP) and New York Heart Association (NYHA) Functional Classification. For more information about the trial, click here.

Reldesemtiv has been the subject of five Phase 1 clinical trials in healthy volunteers evaluating its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics. Cytokinetics and Astellas announced results from a hypothesis-generating Phase 2 clinical study of reldesemtiv in 70 patients with Type II, Type III and Type IV spinal muscular atrophy (SMA) at the Annual Cure SMA Conference in June 2018. The study showed statistically significant concentration-dependent increases in changes from baseline in Six Minute Walk Distance (6MWD), a sub-maximal exercise test of aerobic capacity and endurance. The study also showed statistically significant increases for Maximal Expiratory Pressure (MEP), a measure of strength of respiratory muscles. Adverse events were similar between groups receiving reldesemtiv and placebo. For more information about the trial, click here.

FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints in ALS) – Cytokinetics announced results from FORTITUDE-ALS, a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in patients with ALS at the American Academy of Neurology meeting in May 2019. The trial enrolled 458 patients with ALS in the US, Canada, Europe and Australia. The trial did not achieve statistical significance for its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing, but all patients on all doses of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with clinically meaningful differences emerging over time. For more information about the trial, click here.