Real-World Population Representative of Patients Enrolled in GALACTIC-HF Indicate a High-Need, High-Risk Population with Heart Failure
New Results from COSMIC-HF Show Treatment with Omecamtiv Mecarbil Associated with Improved Right Ventricular Function
SOUTH SAN FRANCISCO, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting 2020. The first presentation provided analyses of outcomes research in patients with heart failure with reduced ejection fraction (HFrEF) whose characteristics were similar to those patients who met eligibility criteria for GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil. The second presentation provided post hoc analyses of effects of omecamtiv mecarbil on right ventricular function arising from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), the Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with HFrEF.
“These analyses of real-world patients comparable to those in GALACTIC-HF and who are at high risk of cardiovascular events including hospitalization support the design of our Phase 3 clinical trial to assess the potential of omecamtiv mecarbil in patients with clinical unmet need,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Additionally, while we have previously reported that treatment with omecamtiv mecarbil improved left atrial and ventricular function in patients in COSMIC-HF, these additional data suggest that right ventricular function may have been improving as well, underscoring a potential for a more comprehensive effect on overall cardiac function.”
Characteristics and Outcomes of a Real-World Population with HFrEF Representative of Patients Enrolled in GALACTIC-HF
De-identified electronic health records from 2006-2019 of inpatients and outpatients at the Vanderbilt University Medical Center were used to create two real-world cohorts of HFrEF patients. The “clinical cohort” included 3,955 patients matching the eMERGE network phenotype of HFrEF, with a left ventricular ejection fraction (LVEF) ≤ 40%. A “GALACTIC-HF-like cohort” included 1,541 patients identified by mirroring the eligibility criteria of the trial, including hospitalizations, medications, laboratory values and a LVEF ≤ 35%. Approximately 40% of real-world HFrEF patients met the eligibility criteria for GALACTIC-HF in this database. The median age at index date for the clinical cohort was 65, and 61 for the GALACTIC-HF-like cohort. Both cohorts were approximately two-thirds male and 80% white. Aside from a higher median N-terminal B-type natriuretic peptide (NT-proBNP) level in the GALACTIC-HF-like cohort (821 pg/mL vs. 506 pg/mL in the clinical cohort), blood pressure and heart rate of the two cohorts were similar. Comorbidities including chronic kidney disease (31% vs. 21%) and atrial fibrillation (32% vs. 29%) were somewhat higher in the GALACTIC-HF-like cohort than in the clinical cohort, as was utilization of cardiac resynchronization or implantable cardioverter defibrillator (26% vs. 23%). The heart failure hospitalization rate (per 1000 patient-years) was 242 (203, 280; 95% confidence interval [CI]) in the clinical cohort and 396 (350, 442; 95% CI) in the GALACTIC-HF-like cohort during median follow up of 2.7 and 4.1 years, respectively. The rates of HF hospitalization in both cohorts, and in particular the GALACTIC-HF-like cohort, indicates a high-risk population with significant unmet need.
New Results from COSMIC-HF Demonstrate Improvement in Right Ventricular Function During Treatment with Omecamtiv Mecarbil
In COSMIC-HF, 448 patients with stable, symptomatic heart failure and left ventricular ejection fraction (LVEF)