Cytokinetics, Incorporated (Nasdaq: CYTK) today provided an
update regarding the company's clinical trials and business
operations related to its response to the COVID-19 pandemic
alongside its commitment to prioritize the safety, health and
wellbeing of patients, their caregivers, healthcare providers,
partners and employees. The company believes it is on track to
achieve its key strategic objectives for 2020. Cytokinetics
continues to assess the potential impact of the pandemic on its
pipeline and business operations and expects to provide further
updates in connection with the reporting of its first quarter
financial results in May.
omecamtiv mecarbil (cardiac myosin
activator)
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 completed
enrollment in mid-2019 with 8,256 participants in over 1,000
clinical sites. As previously reported, the Data Monitoring
Committee (DMC) for GALACTIC-HF recently completed the second and
final planned interim analysis of data from the trial, which
included consideration of pre-specified criteria for futility and
superiority. The DMC recommended that GALACTIC-HF continue without
changes to its conduct. The study record for GALACTIC-HF was
recently updated on www.clinicaltrials.gov to reflect an Estimated
Study Completion Date of August 7, 2020. Cytokinetics expects
results from GALACTIC-HF in Q4 2020. GALACTIC-HF is being conducted
by Amgen in collaboration
with Cytokinetics.
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, is designed to enroll 270 participants.
METEORIC-HF has enrolled participants at approximately 30 clinical
sites in North America. Screening and enrollment of patients in
METEORIC-HF have slowed in response to the COVID-19 pandemic. In
consultation with the DMC, Cytokinetics and Amgen have agreed to
temporarily suspend enrollment in METEORIC-HF to protect the safety
and health of clinical trial participants and healthcare
professionals. For enrolled subjects, Cytokinetics is working
closely with clinical sites to monitor study visits and is taking
certain steps to mitigate potential risk associated with the
COVID-19 pandemic by enabling remote study visits and home delivery
of investigational product to ensure study continuity and
integrity. Cytokinetics continues to enable site start-up
activities with an objective to activate over 50 new sites
throughout North America and Europe. Cytokinetics has reviewed
logistics associated with the conduct of METEORIC-HF and believes
enrollment in METEORIC-HF may be completed by the end of Q4 2020 if
enrollment can be reactivated by the end of Q2 2020. METEORIC-HF is
being conducted by Cytokinetics in collaboration
with Amgen.
AMG 594 (cardiac troponin
activator)
Amgen and Cytokinetics have agreed to suspend
enrollment in the Phase 1 study of AMG 594 to protect the safety
and health of clinical study participants and healthcare
professionals as well as reduce the burden on the healthcare
systems fighting COVID-19. This Phase 1 study is being conducted by
Amgen in collaboration with Cytokinetics.
CK-3773274 (CK-274,
cardiac myosin inhibitor)
REDWOOD-HCM (Randomized
Evaluation of Dosing
With CK-274 in Obstructive
Outflow Disease in
HCM), the Phase 2 clinical trial of CK-274, opened
to enrollment in Q1 2020. Screening and enrollment of patients in
REDWOOD-HCM have slowed in response to the COVID-19 pandemic.
Cytokinetics has temporarily suspended enrollment in REDWOOD-HCM to
protect the safety and health of clinical trial participants and
healthcare professionals. Cytokinetics has been engaging sites to
enable patient-specific plans for dispensation of investigational
product and accommodations for potential remote visits. The company
continues to prioritize start-up activities with an objective to
activate over 20 new sites throughout North America and Europe.
Cytokinetics has reviewed logistics associated with the conduct of
REDWOOD-HCM and believes data from the first cohort of patients
enrolled in REDWOOD-HCM can be available in 2H 2020 if enrollment
in the first cohort can be completed by mid-year.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal
muscle troponin activator (FSTA))
Cytokinetics continues to conduct regulatory
interactions and feasibility and other planning activities in
preparation for the potential advancement of reldesemtiv to a Phase
3 trial in patients with ALS. The company does not expect that the
COVID-19 pandemic will affect 2020 objectives relating to this
program.
Corporate: Business Operations
In response to the COVID-19 pandemic, the
company has taken steps to ensure the safety and wellbeing of
employees and their families and to comply with guidance from
federal, state and local authorities. Cytokinetics has instituted a
mandatory work-from-home policy for most of its employees and has
implemented support programs and made technology resources
available to employees with the objective to minimize disruption to
business operations. The policy permits designated employees to
attend to certain essential business and corporate activities,
including key research and other laboratory activities. For these
employees, Cytokinetics has established safety guidelines to limit
the number of employees onsite and to ensure physical distancing,
and the regular conduct of appropriate disinfection cleanings in
its facilities.
The company believes that the fundamentals of
its business remain intact and it is on track to achieve its key
strategic objectives for 2020. The company also believes that it
has manufactured adequate supplies of drug substance and
investigational product to complete ongoing trials as well as to
support planned clinical trials into 2021 and does not expect
delays to its clinical trials due to manufacturing or supply-chain
issues. Cytokinetics recently announced that it ended 2019 with
cash, cash equivalents and investments totaling $267.7 million
representing more than two years of cash runway based on 2020
financial guidance. The company continues to assess the potential
impact to its business given the ongoing nature of the COVID-19
pandemic and plans to provide further updates together with its
first quarter financial results in May.
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 cardiac myotropes increase cardiac contractility without
affecting intracellular myocyte calcium concentrations or
myocardial oxygen consumption.2-4 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, 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 Reldesemtiv and Potential Phase 3
Clinical Trial
Skeletal muscle contractility is driven by the
sarcomere, the fundamental unit of skeletal muscle contraction and
a highly ordered cytoskeletal structure composed of several key
proteins. Skeletal muscle myosin is the motor protein that converts
chemical energy into mechanical force through its interaction with
actin. A set of regulatory proteins, which includes tropomyosin and
several types of troponin, make the actin-myosin interaction
dependent on changes in intracellular calcium
levels. Reldesemtiv, a next-generation FSTA arising from
Cytokinetics’ skeletal muscle contractility program, slows the rate
of calcium release from the regulatory troponin complex of fast
skeletal muscle fibers, which sensitizes the sarcomere to calcium,
leading to an increase in skeletal muscle
contractility. Reldesemtiv has demonstrated
pharmacological activity that may lead to new therapeutic options
for diseases associated with skeletal muscle weakness and
fatigue.
FORTITUDE-ALS, the Phase 2 clinical trial
of reldesemtiv in patients with ALS, did not achieve
statistical significance for a pre-specified dose-response
relationship in the primary endpoint of change from baseline in
slow vital capacity (SVC) after 12 weeks of dosing. However,
patients on all dose groups of reldesemtiv declined
numerically less than patients on placebo for SVC and ALS
Functional Rating Scale-Revised (ALSFRS-R), with larger differences
emerging over time. These data may support the advancement of
reldesemtiv in patients with ALS and we are conducting, feasibility
and other planning activities in preparation for a potential Phase
3 clinical trial of reldesemtiv in patients with ALS. We are also
engaging with FDA, EMA and health technology assessment
organizations to define our potential path forward including the
clinical and reimbursement value of potential endpoints for a
pivotal Phase 3 trial that we are considering. We plan to await
results of GALACTIC-HF before potentially starting the next trial.
FORTITUDE-ALS was previously conducted by Cytokinetics under our
collaboration with Astellas.
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; 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; 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: Cytokinetics Joanna Siegall Manager,
Corporate Communications & Investor Relations (425)
314-1721
- 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.
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024