Cytokinetics Announces Baseline Characteristics from GALACTIC-HF at ACC.20/WCC Virtual
March 30 2020 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
patient baseline characteristics and demographics 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, were published during the American College of Cardiology
69th Annual Scientific Session together with the World Congress of
Cardiology (ACC.20/WCC).
|
Overall(N=8,256) |
Inpatient(N=2,083) |
Outpatient(N=6,173) |
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) |
Male, % |
79 |
80 |
78 |
White, % |
78 |
82 |
76 |
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 |
MRA, % |
77 |
81 |
76 |
Diuretics other than MRAs, % |
90 |
92 |
89 |
Digitalis Glycosides, % |
17 |
17 |
17 |
SGLT2 Inhibitors, % |
3 |
3 |
3 |
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, with
funding and strategic support from Servier. Omecamtiv mecarbil is
the subject of a comprehensive Phase 3 clinical trials program
comprised of GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure), a large, Phase 3 global, event-driven,
cardiovascular outcomes study, and METEORIC-HF
(Multicenter Exercise
Tolerance Evaluation of
Omecamtiv Mecarbil Related to
Increased Contractility in
Heart Failure), a Phase 3
clinical trial designed to evaluate the effect of treatment with
omecamtiv mecarbil compared to placebo on exercise capacity.
About Cytokinetics and Amgen
Collaboration
In 2006, Cytokinetics and Amgen entered into a
strategic alliance to discover, develop and commercialize novel
small molecule therapeutics designed to activate the cardiac
sarcomere for the potential treatment of heart failure. Omecamtiv
mecarbil is being developed by Amgen in collaboration with
Cytokinetics, with funding and strategic support from Servier.
Amgen holds an exclusive, worldwide license to omecamtiv mecarbil
and related compounds, subject to Cytokinetics' specified
development and commercialization rights. Cytokinetics is eligible
for pre-commercialization and commercialization milestone payments
and royalties that escalate based on increasing levels of annual
net sales of products commercialized under the agreement.
Cytokinetics has co-invested with Amgen in the Phase 3 development
program of omecamtiv mecarbil in exchange for increased royalties
from Amgen on worldwide sales of omecamtiv mecarbil outside Japan
and co-promotion rights in institutional care settings in North
America. Amgen has also entered an alliance with Servier for
exclusive commercialization rights for omecamtiv mecarbil in Europe
as well as the Commonwealth of Independent States, including
Russia.
About Cytokinetics
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.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on Twitter, LinkedIn,
Facebook and YouTube.
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.
Contact:CytokineticsDiane
WeiserSenior Vice President, Corporate Communications, Investor
Relations(415) 290-7757
References
1 Planelles-Herrero VJ, Hartman JJ,
Robert-Paganin J. et al. Mechanistic and structural basis for
activation of cardiac myosin force production by omecamtiv
mecarbil. Nat Commun. 2017;8:190. 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.
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