Over 50 clinical trials with a single focus:Improve lives
|GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) – GALACTIC-HF was a Phase 3, double-blind, placebo-controlled, multicenter clinical trial conducted by Amgen in collaboration with Cytokinetics, and one of the largest Phase 3 global cardiovascular outcomes studies in heart failure ever conducted. The trial evaluated the effect of treatment with omecamtiv mecarbil compared with placebo in approximately 8,256 patients with chronic heart failure with reduced ejection fraction (HFrEF) who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (hazard ratio, 0.92; 95% confidence interval, 0.89 to 0.99; p=0.0252). No reduction in the secondary endpoint of time to CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between the treatment arms. These results were published in NEJM, available online here.
A secondary analysis from GALACTIC-HF of ejection fraction as a continuous variable demonstrated a progressively larger treatment effect of omecamtiv mecarbil with decreasing ejection fraction (interaction p = 0.013 by EF quartile). For more information about this trial, click here.
|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 designed to enroll approximately 270 patients with HFrEF at sites throughout the U.S., Canada and Europe. Patient enrollment was complete in METEORIC-HF in June 2021. For more information about this 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 of aficamten in patients with symptomatic obstructive HCM (oHCM) on background medical therapy. The primary objective of the trial is to determine the safety and tolerability of aficamten. The secondary objectives are to describe the concentration-response relationship of aficamten on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment, to describe the dose response relationship of aficamten, and to evaluate the plasma concentrations of aficamten in patients with oHCM. 17 investigative sites in North America and Europe screened for patients to enroll in Cohort 1 and 2 of REDWOOD-HCM. Results from Cohorts 1 and 2 of REDWOOD-HCM demonstrated that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with aficamten (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Reductions in LVOT-G occurred within two weeks of initiating treatment with aficamten, were maximized within two to six weeks of the start of dose titration, and were sustained until the end of treatment at 10 weeks. The observed reductions in LVOT-G were dose dependent, with patients achieving greater reductions of LVOT-G with increasing doses of aficamten. Treatment with aficamten in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to aficamten and no treatment interruptions occurred on aficamten. Cohort 3 is currently enrolling patients whose background therapy includes disopyramide. 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.|
|COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) – COURAGE-ALS is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv expected to enroll approximately 555 patients with ALS. Patients will be randomized 2:1 to receive 300 mg of reldesemtiv or matching placebo dosed orally twice daily for 24 weeks, followed by a 24-week period in which all patients will receive 300 mg of reldesemtiv twice daily. Eligible patients will be within the first two years of their first symptom of muscle weakness, have a vital capacity of ≥65% predicted, and a screening ALS Functional Rating Scale – Revised (ALSFRS-R) ≤44. Patients currently taking stable doses of Radicava® (edaravone) and/or Rilutek® (riluzole) will be permitted and randomization stratified accordingly. The primary efficacy endpoint will be change from baseline to 24 weeks in ALSFRS-R. Secondary endpoints include combined assessment of ALSFRS-R total score, time to onset of respiratory insufficiency and survival time up to week 24 using a joint rank test; change from baseline to 24 weeks for vital capacity; ALSAQ-40; and bilateral handgrip strength. Two unblinded interim analyses by the Data Monitoring Committee are planned. The first interim analysis will assess for futility, 12 weeks after approximately one-third or more of the planned sample size is randomized. A second interim analysis will also assess for futility, and there will be an option for a fixed increase in total enrollment, if necessary, to augment the statistical power of the trial. For more information about the trial, click here.|