Correction: Cytokinetics Announces Baseline Characteristics from GALACTIC-HF at ACC.20/WCC Virtual
In the press release published at
|Time from most recent HF hospitalization/ ED visit (months), median (Q1-Q3)||2 (1-5)||-||3 (2-6)|
|Age (years), mean (SD)||65 (11)||65 (11)||64 (11)|
|LVEF (%), mean (SD)||27 (6)||27 (6)||27 (6)|
|NYHA Class II/III/IV, %||53/ 44/ 3||37/ 57/ 6||59/ 39/ 2|
|NT-proBNP (pg/mL), median (Q1-Q3)||1998 (990-4078)||2509 (1240-5133)||1884 (923-3772)|
|Ischemic Heart Disease Etiology, %||55||56||54|
|KCCQ Total Symptom Score, mean (SD)||66 (25)||53 (25)||71 (23)|
|Atrial Fibrillation or Flutter History, %||42||48||40|
|Chronic Kidney Disease, %||36||39||35|
|eGFR (mL/min/1.73m2), median (Q1-Q3)||59 (44-74)||54 (41-70)||60 (45-75)|
|SBP (mmHg), mean (SD)||117 (15)||114 (14)||117 (16)|
|ACEi, ARB or ARNi, %||87||83||88|
|ARNi (ENTRESTO®) %||19||14||19|
|Beta Blocker, %||94||93||95|
|Diuretics other than MRAs, %||90||92||89|
|Digitalis Glycosides, %||17||17||17|
|SGLT2 Inhibitors, %||3||3||3|
“Patients enrolled in GALACTIC-HF represent a heart failure population at risk for cardiovascular events despite being well-treated in accordance with international guidelines. The baseline patient characteristics of this trial describe a balanced representation from countries around the world and from both the inpatient and outpatient setting,” said
GALACTIC-HF is designed to evaluate whether treatment with omecamtiv mecarbil, dosed twice-daily in accordance with a pharmacokinetic-guided dose selection 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. GALACTIC-HF opened to enrollment in late 2016 and was designed to enroll approximately 8,000 heart failure patients with reduced ejection fraction who either were hospitalized for a primary reason of heart failure when enrolled or had had a hospitalization or admission to an emergency room for a primary reason of heart failure within one year prior to screening. Patients were also required to have a left ventricular ejection fraction (LVEF) ≤35% and elevated natriuretic peptides. GALACTIC-HF completed enrollment in 2019, having enrolled 8,256 patients in 35 countries.
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program
Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator 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.1-3 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
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA). Astellas currently holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting REDWOOD-HCM, a Phase 2 trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act").
Senior Vice President, Corporate Communications, Investor Relations
1 Planelles-Herrero VJ, Hartman JJ,
2 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.
3 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.
Source: Cytokinetics, Incorporated