Benzinga | Oct 2, 2020 07:31AM EDT

Cytokinetics Highlights Publication Of Manuscript Detailing Baseline Characteristics Of GALACTIC-HF In European Journal Of Heart Failure

Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that a manuscript detailing the baseline characteristics from 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, was published in the European Journal of Heart Failure.1 Omecamtiv mecarbil, a selective cardiac myosin activator, is being developed for the potential treatment of heart failure with reduced ejection fraction under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.

"GALACTIC-HF enrolled hospitalized and recently discharged heart failure patients with baseline characteristics that correlate with a high risk of cardiovascular events and symptom burden despite receiving standard of care therapies," said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President, Research and Development. "We look forward to receiving the results of GALACTIC-HF."

GALACTIC-HF is designed to evaluate whether treatment with omecamtiv mecarbil, dosed twice-daily in accordance with a pharmacokinetic-guided dose optimization regimen, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization or other urgent, unscheduled treatment for heart failure) and cardiovascular (CV) death in patients with chronic heart failure and reduced ejection fraction (HFrEF). Patients enrolled in GALACTIC-HF were required to have a diagnosis of HFrEF with left ventricular ejection fraction (LVEF) ?35% and elevated natriuretic peptides. Patients were either currently hospitalized for heart failure (25% of total enrollment), or had a recent hospitalization, or a visit to an emergency room or urgent care facility for heart failure within the preceding year.

Recent HF Current HF Hospitalization Overall Hospitalization or (8256) (?Inpatient?) ED Visit Within (N=2084) One Year (?Outpatient?) (N=6172)Demographics Age (years), mean (SD) 64.5 (11.3) 65.0 (11.3) 64.4 (11.4)Sex, female, n (%) 1756 (21.3) 411 (19.7) 1345 (21.8)Race, n (%) White 6421 (77.8) 1706 (81.9) 4715 (76.4)Asian 710 (8.6) 184 (8.8) 526 (8.5)Black or African American 562 (6.8) 105 (5.0) 457 (7.4)Other* 563 (6.8) 89 (4.3) 474 (7.7)Ethnicity, Hispanic/Latino n (%) 1771 (21.5) 355 (17.0) 1416 (22.9)Geographic Region, n (%) Eastern Europe/ Russia 2705 (32.8) 915 (43.9) 1790 (29.0)Western Europe/ South Africa/ 1921 (23.3) 486 (23.3) 1435 (23.3)AustralasiaLatin and South America 1574 (19.1) 326 (15.6) 1248 (20.2)US and Canada 1386 (16.8) 180 (8.6) 1206 (19.5)Asia 670 (8.1) 177 (8.5) 493 (8.0)Clinical Characteristics Medical Conditions, n (%) Coronary artery disease 5144 (62.3) 1317 (63.2) 3827 (62.0)Peripheral artery disease 847 (10.3) 215 (10.3) 632 (10.2)Stroke 753 (9.1) 197 (9.5) 556 (9.0)Atrial fibrillation or flutter 3472 (42.1) 995 (47.7) 2477 (40.1)historyHypertension 5800 (70.3) 1495 (71.7) 4305 (69.8)Hypercholesterolemia 4553 (55.1) 1094 (52.5) 3459 (56.0)Type 2 diabetes mellitus 3313 (40.1) 870 (41.7) 2443 (39.6)Heart Failure History LVEF (%), mean (SD) 26.6 (6.3) 26.5 (6.4) 26.6 (6.2)MAGGIC Score, mean (SD) 23.3 (6.3) 25.0 (6.3) 22.8 (6.3)NYHA classification, n (%) Class II 4391 (53.2) 767 (36.8) 3624 (58.7)Class III 3616 (43.8) 1190 (57.1) 2426 (39.3)Class IV 248 (3.0) 126 (6.0) 122 (2.0)Ischemic heart failure etiology, n 4458 (54.0) 1148 (55.1) 3310 (53.6)(%)KCCQ Total Symptom Score, mean (SD) 66.4 (25.1) 52.6 (25.4) 71.0 (23.2)Vitals and Laboratory Parameters NT-proBNP (pg/mL), 1971 2457 1858median (Q1-Q3) (961-4033) (1185-5073) (900-3749)hsTnI (ng/mL), median (Q3) 0.030 0.036 (0.066) 0.029 (0.044) (0.049)eGFR (mL/min/1.73m2), 59 (41-74) 54 (41-70) 60 (45-75)median (Q1-Q3)Stage ?2; >60 3922 (47.7) 838 (40.2) 3084 (50.0)Stage 3: 30-59 3806 (46.1) 1077 (51.7) 2729 (44.2)Stage 4: 15-29 523 (6.3) 169 (8.1) 354 (5.7)Stage 5: <15 5 (<0.1) 0 (0.0) 5 (<0.1)Medications and Cardiac Devices, n (%)ACEi, ARB or ARNi 7161 (86.7) 1729 (83.0) 5432 (88.0)ARNi 1594 (19.3) 328 (15.7) 1266 (20.5)BB 7763 (94.0) 1931 (92.7) 5832 (94.5)MRA 6358 (77.0) 1686 (80.9) 4672 (75.7)(ACEi, ARB, or ARNi) + MRA + BB 5367 (65.0) 1360 (65.3) 4007 (64.9)SGLT2 Inhibitors 219 (2.7) 56 (2.7) 163 (2.6)Ivabradine 533 (6.5) 156 (7.5) 375 (6.1)Cardiac Resynchronization Therapy 1156 (14.0) 267 (12.8) 889 (14.4)Implantable Cardioverter 2614 (31.7) 598 (28.7) 2016 (32.7)Defibrillator*Includes American Indian or Alaska Native, Native Hawaiian or Other PacificIslander, or Multiple self-identified races

Data are as published in the manuscript and may change with final review