Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-3772271
September 23 2020 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the
first participants have been dosed in a Phase 1 placebo-controlled,
single ascending dose clinical study of CK-3772271 (CK-271). CK-271
is a second cardiac myosin inhibitor, discovered by company
scientists, in development for the potential treatment of
hypertrophic cardiomyopathy (HCM).
“This Phase 1 study of CK-271 builds on our
longstanding approach to advance back-up and follow-on compounds
consistent with our portfolio management strategy,” said Fady I.
Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of
Research & Development. “As we expand the development program
for CK-274 currently in Phase 2, we plan to characterize this
second cardiac myosin inhibitor to determine how it may align with
our objective to develop new therapies for the potential treatment
of multiple diseases associated with excessive cardiac
contractility.”
Phase 1 Clinical
Study Design
The primary objective of this Phase 1
placebo-controlled, single ascending dose clinical study in healthy
adults is to assess the safety and tolerability of CK-271. The
secondary objective is to evaluate the pharmacokinetic profile of
CK-271 following single oral ascending doses. The study design
includes three cohorts, with 8 adults per cohort randomized (6:2)
in a blinded fashion to CK-271 or placebo. Dose escalation
decisions will be made after review of the available safety,
pharmacokinetic, and echocardiography data.
About
CK-271
CK-3772271 (CK-271) is an allosteric cardiac
myosin inhibitor that produces reversible dose- and plasma
concentration-dependent reductions in cardiac contractility without
affecting heart rate in preclinical models. CK-271 reduces
compensatory cardiac hypertrophy and cardiac fibrosis in
preclinical models of hypertrophic cardiomyopathy and heart failure
with preserved ejection fraction. CK-271 is the second cardiac
myosin inhibitor arising from the company’s extensive chemical
optimization program conducted with careful attention to
therapeutic index and pharmacokinetic properties and may be
therapeutically effective by providing rapid relief of excessive
hypercontractility in conditions such as HCM.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is the most
common inherited cardiovascular disorder, with approximately 1 in
500 individuals harboring a genetic mutation worldwide. In some,
the heart muscle (myocardium) becomes abnormally thick
(hypertrophied). The thickening of cardiac muscle leads to the
inside of the left ventricle becoming smaller and stiffer, and thus
the ventricle becomes less able to relax and fill with blood. This
ultimately limits the heart’s pumping function, resulting in
symptoms including chest pain, dizziness, shortness of breath, or
fainting during physical activity. A subset of these patients with
HCM are at high risk of progressive disease which can lead to
atrial fibrillation, stroke and death due to arrhythmias. There are
no current medical treatments that directly address the
hypercontractility that underlies HCM.
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. Cytokinetics is collaborating with Astellas Pharma Inc.
(Astellas) to research, develop and commercialize other novel
mechanism skeletal sarcomere activators (excluding 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 and CK-271, novel cardiac myosin inhibitors
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
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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 timing, design and results
of Cytokinetics’ Phase 1 clinical trial of CK-271; the potential
benefits of CK-271; 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;
Cytokinetics may be unable to obtain or maintain patent or trade
secret protection for its intellectual property; Cytokinetics’
partners decisions with respect to research and development
activities; 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:Diane WeiserSenior Vice President, Corporate
Communications, Investor Relations(415) 290-7757
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