Cytokinetics Joins Global Initiative to Recognize International Rare Disease Day
February 29 2024 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
it is joining the European Organisation for Rare Diseases
(EURORDIS) and the National Organization for Rare Disorders (NORD)
to recognize Rare Disease Day®. Rare Disease Day® is an
international campaign elevating the awareness and public
understanding of rare diseases. The initiative spotlights the more
than 300 million people worldwide living with a rare disease, and
the awareness efforts focused on bringing them more equitable
access to diagnosis, treatment, care and social opportunity.
“We are proud to be joining EURORDIS, NORD and
countless others worldwide to recognize Rare Disease Day and stand
in support of those who bravely navigate the complexities and
challenges of rare diseases," said Robert I. Blum, Cytokinetics’
President and Chief Executive Officer. “As we advance aficamten for
patients with obstructive hypertrophic cardiomyopathy with
regulatory submissions planned to occur later this year, we also
remain committed to championing health equity and are supporting
activities to help ensure access to education, support, clinical
trials and care for those with rare diseases.”
About Rare Disease Day
Rare Disease Day, which takes place every year
on the last day in February, was established in Europe in
2008 by the European Organisation for Rare
Diseases (EURORDIS) and is now observed in more than 80
nations. In the United States, Rare Disease Day is sponsored
by the National Organization for Rare Disorders (NORD), a
leading independent, non-profit organization committed to the
identification, treatment, and cure of rare diseases. According to
the National Institutes of Health (NIH), in the US, a
rare disease is defined as one that affects fewer than 200,000
people. With over 6,000 rare diseases, 25 million Americans are
living with a rare disease, but only 5 percent of these diseases
have a treatment.
About Hypertrophic
Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a disease
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. This
ultimately limits the heart’s pumping function, resulting in
reduced exercise capacity and symptoms including chest pain,
dizziness, shortness of breath, or fainting during physical
activity. HCM is the most common monogenic inherited cardiovascular
disorder, with approximately 280,000 patients diagnosed in the
U.S., however, there are an estimated 400,000-800,000 additional
patients who remain undiagnosed.1,2,3 Two-thirds of patients with
HCM have obstructive HCM (oHCM), where the thickening of the
cardiac muscle leads to left ventricular outflow tract (LVOT)
obstruction, while one-third have non-obstructive HCM (nHCM), where
blood flow isn’t impacted, but the heart muscle is still thickened.
People with HCM are at high risk of also developing cardiovascular
complications including atrial fibrillation, stroke and mitral
valve disease.4 People with HCM are at risk for potentially fatal
ventricular arrhythmias and it is one of the leading causes of
sudden cardiac death in younger people or athletes.5 A subset of
patients with HCM are at high risk of progressive disease leading
to dilated cardiomyopathy and heart failure necessitating cardiac
transplantation.
About Cytokinetics
Cytokinetics is a late-stage, specialty
cardiovascular 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 cardiac muscle performance is
compromised. As a leader in muscle biology and the mechanics of
muscle performance, the company is developing small molecule drug
candidates specifically engineered to impact myocardial muscle
function and contractility. Cytokinetics is preparing for
regulatory submissions for aficamten, its next-in-class cardiac
myosin inhibitor, following positive results from SEQUOIA-HCM, the
pivotal Phase 3 clinical trial in obstructive hypertrophic
cardiomyopathy. Aficamten is also currently being evaluated in two
ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as
monotherapy compared to metoprolol as monotherapy in patients with
obstructive HCM and ACACIA-HCM, evaluating aficamten in patients
with non-obstructive HCM. Cytokinetics is also developing omecamtiv
mecarbil, a cardiac muscle activator, in patients with heart
failure. Additionally, Cytokinetics is developing CK-586, a cardiac
myosin inhibitor with a mechanism of action distinct from aficamten
for the potential treatment of HFpEF, and CK-136, a cardiac
troponin activator for the potential treatment HFrEF and other
types of heart failure, such as right ventricular failure resulting
from impaired cardiac contractility.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on X, 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 of Cytokinetics’ product
candidates and statements regarding our anticipated timing of
regulatory submissions for aficamten. 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 outlines
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.
CYTOKINETICS® and the CYTOKINETICS and C-shaped
logo are registered trademarks of Cytokinetics in the U.S. and
certain other countries.
Contact:Cytokinetics Diane
WeiserSenior Vice President, Corporate Communications, Investor
Relations(415) 290-7757
References:
- CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI:
10.1016/S0140-6736(12)60397-3; Maron et al 2018
10.1056/NEJMra1710575
- Symphony Health 2016-2021 Patient Claims Data DoF;
- Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I.
Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in
the United States. Am J Cardiol. 2016; 15;117(10):1651-1654.
- Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer,
M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis
and treatment of hypertrophic cardiomyopathy. A report of the
American College of Cardiology Foundation/American Heart
Association Task Force on practice guidelines. Journal of the
American College of Cardiology and Circulation, 58, e212-260.
- Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in
hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022
Jan 1;37(1):15-21
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