Cytokinetics announces data from two presentations of omecamtiv mecarbil at Heart Failure Society of America virtual meeting.

Cytokinetics, Incorporated 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 III 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 II clinical trial evaluating omecamtiv mecarbil in patients with HFrEF. Characteristics and Outcomes of a Real-World Population with HFrEF Representative of Patients Enrolled in GALACTIC-HF study: 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) less than 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 less than 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) less than 40% were randomly assigned to omecamtiv mecarbil [25 mg twice daily (n=150); or 25 mg twice daily with pharmacokinetic-guided dose selection to 50 mg twice daily (PK titration group, n=149)] or placebo (n=149) in a double-blind fashion for 20 weeks. Previously reported results showed improvements in measures of left ventricular function in the PK group. This post-hoc analysis assessed the effect of omecamtiv mecarbil on right ventricular structure and function. Patients in the PK titration group who received omecamtiv mecarbil had improved measures of right ventricular function, including right ventricular systolic ejection time (RV-SET) (p<0.001), right ventricular end-systolic area (rv-esa) (p="0.012)," and right ventricular outflow tract velocity time integral (rvot-vti) (p="0.002)." additionally, measures of right ventricular pulmonary arterial coupling were also improved, including pulmonary arterial systolic pressure (pasp) (p="0.008)," tricuspid annular plane systolic excursion (tapse) pasp ratio (p="0.002)," and rvot-vti pasp ratio (p="0.002)," indicating improved blood flow from the right ventricle was not met with increased pulmonary arterial resistance. omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (hfref) under a collaboration between amgen and cytokinetics, with funding and strategic support from servier.>