Cytokinetics Announces Publication of Manuscript Detailing Baseline Characteristics of GALACTIC-HF in European Journal of Heart Failure
Heart Failure Patients in Phase 3 Clinical Trial of Omecamtiv Mecarbil Are at High Risk of Cardiovascular Events and Symptom Burden
“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
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.
Overall (8256) | Current HF Hospitalization (“Inpatient”) (N=2084) |
Recent HF Hospitalization or ED Visit Within 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 |
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) |
2705 (32.8) | 915 (43.9) | 1790 (29.0) | |
1921 (23.3) | 486 (23.3) | 1435 (23.3) | |
Latin and |
1574 (19.1) | 326 (15.6) | 1248 (20.2) |
US and |
1386 (16.8) | 180 (8.6) | 1206 (19.5) |
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 history | 3472 (42.1) | 995 (47.7) | 2477 (40.1) |
Hypertension | 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), median (Q1-Q3) |
1971 (961-4033) |
2457 (1185-5073) |
1858 (900-3749) |
hsTnI (ng/mL), median (Q3) | 0.030 (0.049) | 0.036 (0.066) | 0.029 (0.044) |
eGFR (mL/min/1.73m2), median (Q1-Q3) |
59 (41-74) | 54 (41-70) | 60 (45-75) |
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 Defibrillator | 2614 (31.7) | 598 (28.7) | 2016 (32.7) |
*Includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, or Multiple self-identified races |
Data are as published in the manuscript and may change with final review
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program
Omecamtiv mecarbil is an investigational selective cardiac myosin activator, the first of a novel class of myotropes2, that binds to the catalytic domain of myosin. Preclinical research has shown that cardiac myosin activators increase cardiac contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption.3-5 Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction.
Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and
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Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the GALACTIC-HF clinical trial, including the expected timing of the availability of top-line results; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; Cytokinetics' and its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
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References
1 Teerlink JR, Diaz R, Felker GM, McMurray JJ, Metra M, Solomon SD, Adams KF, Anand I, Arias‐Mendoza A, Biering‐Sørensen T, Böhm M, Bonderman D, Cleland JGF, Corbalan R, Crespo‐Leiro, MG, Dahlström U, Diaz R, Echeverria Correa LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Lund M, Macdonald P, Mareev V, Momomura Si, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC,
2 Psotka MA, Gottlieb SS, Francis GS et al. Cardiac Calcitropes, Myotropes, and Mitotropes. JACC. 2019; 73:2345-53.
3 Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al. Mechanistic and structural basis for activation of cardiac myosin force production by omecamtiv mecarbil.
4 Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.
5 Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011 Mar 18;331(6023):1439-43.
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