Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
additional results from COSMIC-HF (
Chronic
Oral
Study of
Myosin Activation to
Increase
Contractility in
Heart
Failure), a Phase 2 trial evaluating omecamtiv
mecarbil in patients with chronic heart failure, will be presented
in a Moderated Poster Session at the American College of
Cardiology’s 68th Annual Scientific Session (ACC.19) in New Orleans
on March, 18, 2019.
Title: Effect of Omecamtiv
Mecarbil in Patients With Atrial Fibrillation and Heart Failure
With Reduced Ejection Fraction: Results From COSMIC-HF
Speaker: John Teerlink, M.D., Professor of
Clinical Medicine, University of California San Francisco and
Director of Heart Failure, San Francisco Veterans Affairs Medical
CenterSession: Heart Failure and Cardiomyopathies:
Latest Discoveries in Basic, Translational and Clinical
ScienceDate: March 18, 2019Presentation
Time: 1:00 – 1:10 PM CTLocation: New
Orleans Ernest N. Morial Convention Center, Poster Hall, Hall F
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials
Program
Omecamtiv mecarbil is a novel, 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.i,ii,iii 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 cardiovascular
outcomes study being conducted by Amgen in collaboration with
Cytokinetics, with the support of Servier 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, being
conducted by Cytokinetics in collaboration with Amgen, with support
from Servier.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and best-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). Reldesemtiv has been granted orphan drug
designation by the FDA for the potential treatment of spinal
muscular atrophy. Reldesemtiv was the subject of a Phase 2 clinical
study in patients with spinal muscular atrophy which showed
increases in measures of endurance and stamina consistent with the
mechanism of action. Reldesemtiv is currently the subject of a
Phase 2 clinical trial in patients with amyotrophic lateral
sclerosis. Astellas 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. 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 Cytokinetics' and its partners' research and
development activities; the timing of enrollment of patients
in Cytokinetics' and its partners' clinical trials; the
design, timing, results, significance and utility of preclinical
and clinical results; and the properties and potential benefits
of Cytokinetics' 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, patient
enrollment for or conduct of clinical trials may be difficult or
delayed, 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, and Cytokinetics may be unable to obtain
or maintain patent or trade secret protection for its intellectual
property; Astellas' decisions with respect to the design,
initiation, conduct, timing and continuation of development
activities for reldesemtiv; 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
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
___________________________
i 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.
ii 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.
iii 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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