Cytokinetics Announces Partnership to Improve Prediction of Risk and Outcomes in Hypertrophic Cardiomyopathy
August 18 2020 - 7:30AM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced a $1
million grant and four-year partnership with the HCM Registry
(HCMR), a global registry of patients with hypertrophic
cardiomyopathy (HCM) focused on improving predictive measures of
risk for complications and identifying biomarkers associated with
adverse clinical outcomes. The HCMR was designed as the first
prospective multinational registry to identify novel prognostic
markers in HCM, including CMR markers of fibrosis, genetic markers,
and biomarkers. It has been funded to date by the National Heart,
Lung, and Blood Institute, part of the National Institutes of
Health (Grant number: U01 HL117006-01A1) and is being conducted by
the University of Virginia and the University of Oxford. As an
industry sponsor, Cytokinetics will join the HCMR Steering
Committee in an observational capacity.
“We are pleased to partner with the HCM Registry
to support better understandings of predictive risk factors for
developing complications associated with living with HCM,” said
Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President
of Research & Development. “HCM can severely impact the daily
lives of those diagnosed with the condition. Our long-term
commitment to this important initiative is aligned with our
dedication to outcomes research alongside our own drug development
in the interests of patient-centric engagement and improved
healthspan.”
The HCMR is a prospective, observational study
that enrolled 2,755 participants from 44 sites in six countries in
North America and Europe who will be followed for at least five
years and up to 10. Enrollment began in 2014 and completed in 2017.
Primary outcome measures include cardiac death, aborted sudden
cardiac death, heart transplant and left ventricular assist device
placement. Secondary outcome measures include all-cause mortality,
ventricular tachyarrhythmias, hospitalization for heart failure,
atrial fibrillation and stroke. The results of the study will help
predict the risk of developing complications associated with HCM
and provide evidence to inform better treatment decisions.
Additional information is available at
www.clinicaltrials.gov/ct2/show/NCT01915615.
About Hypertrophic
Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is an
inherited cardiovascular disorder in which 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. In the majority of
patients, thickening of the heart muscle in the left ventricular
outflow tract obstructs the flow of blood out of the heart. 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 patients with HCM
are at high risk of progressive disease which can lead to
ventricular arrhythmias, atrial fibrillation, stroke, heart failure
and sudden cardiac death. 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, 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
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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 Cytokinetics' and its partners' research and
development activities of Cytokinetics’ product 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 the risks related
to Cytokinetics' business outlined
in Cytokinetics' filings with the Securities and
Exchange Commission. Forward-looking statements are not guarantees
of future performance, and Cytokinetics' actual results
of operations, financial condition and liquidity, and the
development of the industry in which it operates, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements
that Cytokinetics makes in this press release speak only
as of the date of this press
release. Cytokinetics assumes no obligation to update its
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
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