Cytokinetics, Incorporated (Nasdaq: CYTK) management plans to
provide updates on the company’s advancing cardiovascular pipeline
and strategies to build a commercial franchise at “Activate.
Inhibit. Empower: Changing the Course of Cardiovascular Disease,” a
Virtual Analyst & Investor Event, today at 8:30 AM Eastern
Time. As the treatment landscape in heart failure and hypertrophic
cardiomyopathies is rapidly evolving, the event will also feature
commentary and perspectives from leading physician experts and
patient advocates.
“This is a transformative time for Cytokinetics
as we execute against our Vision 2025 to be the leading muscle
biology focused company dedicated to meaningfully improving the
lives of patients with diseases of impaired muscle function through
access to novel medicines arising from our research,” said Robert
I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our
cardiovascular pipeline is among the most innovative in the
biopharmaceutical industry with a combination of first-in-class and
next-generation cardiac myosin activators and inhibitors, being
developed independently and in collaboration with partners. We
believe these potential medicines may alter the course of diseases
of impaired cardiac contractility and successfully transition
Cytokinetics into a fully integrated biopharmaceutical
company.”
“Our pioneering research has led to the
discovery of novel cardiac drug candidates that modulate sarcomere
function by either increasing or decreasing cardiovascular
biomechanics and contractility,” said Fady I. Malik, M.D., Ph.D.,
Cytokinetics’ Executive Vice President, Research & Development.
“An integrated suite of purpose-built technologies has enabled our
ability to impact to develop investigational medicines that are
designed to address a broad array of phenotypes in heart failure
that, despite available pharmaceutical and surgical interventions,
represent large unmet needs among patients worldwide.”
Omecamtiv Mecarbil:
Cardiac Myosin Activator (Heart Failure)
Management will present an overview of the
clinical development program for omecamtiv mecarbil featuring a
review 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 trial of omecamtiv mecarbil from which
results are expected in Q4 2020 and METEORIC-HF
(Multicenter Exercise
Tolerance Evaluation of
Omecamtiv Mecarbil Related to
Increased Contractility in
Heart Failure), a second Phase 3
clinical trial of omecamtiv mecarbil, designed to evaluate the
effect of treatment with omecamtiv mecarbil compared to placebo on
exercise capacity. 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. The company will also
present results from previous trials including COSMIC-HF, a Phase 2
trial of omecamtiv mecarbil, and discuss cardiovascular biomarkers
end endpoints correlative with outcomes.
CK-3773274 (CK-274): Cardiac Myosin
Inhibitor (Hypertrophic Cardiomyopathy (HCM))
Management will also present a review of recent
progress with CK-274 the company’s next-in-class cardiac myosin
inhibitor, including a review of the Phase 1 data supportive of the
design and conduct of REDWOOD-HCM (Randomized
Evaluation of Dosing
With CK-274 in Obstructive
Outflow Disease in
HCM), a Phase 2 clinical trial
which began enrollment earlier this year and has resumed following
a brief suspension in enrollment due to COVID-19. In addition, the
team will discuss additional plans for the development of CK-274 in
cardiovascular diseases associated with hypercontractility.
Cardiovascular Franchise
Strategy
In preparation for potential commercialization
of omecamtiv mecarbil, the company will highlight strategic plans
to leverage its leadership in cardiac muscle biology to develop and
commercialize innovative medicines for cardiovascular diseases,
with initial focus to heart failure with reduced ejection fraction
(HFrEF) and hypertrophic cardiomyopathies (HCM). Company management
will elaborate on its business strategy to leverage its corporate
partnerships and focus to improve the healthspan of patients with
cardiovascular disease by enabling them to feel better, function
better, and live longer.
Physician Experts and Patient
Advocates
At today’s Virtual Analyst & Investor Day, a
panel of leading physician experts in the treatment of heart
failure and HCM will discuss opportunities and perspectives on the
changing landscape in heart failure therapy and emerging treatments
for HCM. Panelists include:
- John McMurray, M.D., Professor of Medical
Cardiology & Honorary Consultant Cardiologist, Institute of
Cardiovascular & Medical Sciences, British Heart Foundation
Cardiovascular Research Centre, University of Glasgow
- Adrian Hernandez, M.D., MHS, Executive
Director, Duke Clinical Research Institute, Vice Dean, Duke
University School of Medicine
- Larry Allen, M.D., MHS, Professor of Medicine,
Kenneth Poirier Chair; Associate Head for Clinical Affairs,
Cardiology; Medical Director, Advanced Heart Failure, University of
Colorado School of Medicine
- Martin Maron, M.D., Director Hypertrophic
Cardiomyopathy Center, Tufts Medical Center and Chanin T. Mast
Hypertrophic Cardiomyopathy Center, Morristown Medical Center
- Anjali Tiku Owens, M.D., Medical Director,
Center for Inherited Cardiac Disease, Assistant Professor of
Medicine, University of Pennsylvania
- Andrew Wang, M.D., Professor of Medicine, Vice
Chief for Clinical Services, Duke University School of
Medicine
In addition, a panel of patients with heart
failure and HCM will discuss living with cardiovascular diseases
and their interests and objectives in engaging together with
colleagues in the advocacy community.
Access to Virtual Event
Interested parties may access today’s live
virtual event by registering online at
https://bit.ly/CYTKInvestorDay or by visiting the Investors &
Media section of Cytokinetics’ website at www.cytokinetics.com. An
archived replay of the virtual event will be available via
Cytokinetics’ website until July 15, 2021.
About Omecamtiv Mecarbil and the Phase 3
Clinical Trials Program
Omecamtiv mecarbil is a novel, selective
cardiac myosin activator, also known as a cardiac myotrope,1 that
binds to the catalytic domain of myosin. Preclinical research has
shown that omecamtiv mecarbil increases cardiac contractility
without increasing intracellular myocyte calcium concentrations or
myocardial oxygen consumption. 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. 2-4
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, a Phase 3 clinical trial designed to
evaluate the effect of treatment with omecamtiv mecarbil compared
to placebo on cardiovascular outcomes and METEORIC-HF, a Phase 3
clinical trial designed to evaluate the effect of treatment with
omecamtiv mecarbil compared to placebo on exercise capacity.
About CK-274 and
REDWOOD-HCM
CK-274 is a novel, oral, small molecule cardiac
myosin inhibitor that company scientists discovered independent of
its collaborations. CK-274 arose from an extensive chemical
optimization program conducted with careful attention to
therapeutic index and pharmacokinetic properties that may translate
into next-in-class potential in clinical development. CK-274 was
designed to reduce the hypercontractility that is associated with
hypertrophic cardiomyopathy (HCM). In preclinical models, CK-274
reduces myocardial contractility by binding directly to cardiac
myosin at a distinct and selective allosteric binding site, thereby
preventing myosin from entering a force producing state. CK-274
reduces the number of active actin-myosin cross bridges during each
cardiac cycle and consequently reduces myocardial
contractility.
REDWOOD-HCM is a multi-center, randomized,
placebo-controlled, double-blind, dose-finding Phase 2 clinical
trial in patients with symptomatic, obstructive HCM. The primary
objective of the trial is to determine the safety and tolerability
of CK-274. The secondary objectives are to describe the
concentration-response and dose-response relationship of CK-274 on
the resting and post-Valsalva left ventricular outflow tract
gradient as measured by echocardiography during 10 weeks of
treatment.
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 and Ji Xing
Pharmaceuticals/RTW Investments Collaboration
Cytokinetics has granted Ji Xing Pharmaceuticals
Limited an exclusive license to develop and commercialize CK-274 in
China and Taiwan, in accordance with Cytokinetics’ planned global
registration programs. Cytokinetics will receive an upfront payment
and is eligible to receive development and commercial milestone
payments and royalties on future sales of CK-274 in China and
Taiwan. Under a separate funding agreement, Cytokinetics has
received options for additional funding from investment funds
managed by RTW Investments, LP for the further development of
CK-274 in hypertrophic cardiomyopathies in exchange for royalties
on future sales of CK-274 in the United States and certain European
countries.
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 developing reldesemtiv, a
fast skeletal muscle troponin activator (FSTA) for the potential
treatment of ALS and other neuromuscular indications following
conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The
company is considering potential advancement of reldesemtiv to
Phase 3 pending ongoing regulatory interactions. Cytokinetics is
collaborating with Astellas Pharma Inc. (Astellas) to research,
develop and commercialize other novel mechanism skeletal sarcomere
activators (not including FSTAs). 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 has granted Ji Xing Pharmaceuticals Limited an
exclusive license to develop and commercialize CK-274 in China and
Taiwan, in accordance with Cytokinetics’ planned global
registration programs. Cytokinetics is conducting REDWOOD-HCM, a
Phase 2 clinical 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; statements relating to
the REDWOOD-HCM clinical trial; statements relating to the
potential benefits of CK-274; statements relating to our
interactions with regulatory authorities in connection to the
potential advancement of a Phase 3 clinical trial of reldesemtiv in
patients with ALS; the potential benefits of reldesemtiv;
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; the nature of Ji Xing's
decisions with respect to the design, initiation, conduct, timing
and continuation of development activities for CK-274, 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 and licensees, including milestones and royalties on
future potential product sales under Cytokinetics' collaboration
and license 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:Diane WeiserSenior Vice President,
Corporate Communications, Investor Relations(415) 290-7757
References
- Psotka MA, Gottlieb SS, Francis GS et al. Cardiac
Calcitropes, Myotropes, and Mitotropes. JACC. 2019;
73:2345-53.
- 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.
- 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.
- 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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