Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
on February 28 it is joining the European Organisation for Rare
Diseases (EURORDIS) and the National Organization for Rare
Disorders (NORD) to recognize Rare Disease Day®, an international
campaign elevating the awareness and public understanding of rare
diseases. The initiative’s key message of “Rare is many, rare is
strong, rare is proud,” 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.
“As the world navigates the ongoing COVID-19
pandemic, people living with rare diseases need our support, now
more than ever, and we are especially proud to join with national
and global organizations to shine a light on Rare Disease Day,”
said Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “We gain tremendous inspiration from people overcoming the
daily challenges of devastating rare diseases and remain committed
to the development of potential medicines that arise from our
leadership and expertise in muscle biology research.”
Cytokinetics is developing CK-3773274 (CK-274),
a next-generation cardiac myosin inhibitor, for the potential
treatment of hypertrophic cardiomyopathy (HCM). Cytokinetics is
conducting REDWOOD-HCM (Randomized
Evaluation of Dosing
With CK-274 in Obstructive
Outflow Disease in
HCM), a Phase 2 clinical trial of CK-274 in
patients with obstructive HCM (oHCM). Results are expected in
mid-2021, with the goal of starting a Phase 3 clinical trial by
year end. CK-274 was recently granted orphan drug designation for
the treatment of symptomatic HCM by the U.S. Food and Drug
Administration (FDA).
Cytokinetics is also developing reldesemtiv, a
fast skeletal muscle troponin activator, for the potential
treatment of amyotrophic lateral sclerosis (ALS) and spinal
muscular atrophy (SMA). This year, the company is preparing for
COURAGE-ALS, the planned Phase 3 clinical trial of reldesemtiv in
patients with ALS. Reldesemtiv has been granted orphan drug
designation for the treatment of ALS by the FDA and the European
Medicines Agency (EMA). Reldesemtiv was also granted orphan drug
designation for the treatment of SMA by the FDA and EMA.
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 HCM
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
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 atrial
fibrillation, stroke and death due to arrhythmias. There are no FDA
approved medical treatments that directly address the
hypercontractility that underlies HCM.
About ALS
Amyotrophic lateral sclerosis (ALS) is a
progressive neurodegenerative disease that afflicts approximately
20,000 people in the United States and a comparable
number of patients in Europe. Approximately 5,000 new cases of
ALS are diagnosed each year in the United States. The average
life expectancy of an ALS patient is approximately three to five
years after diagnosis and only approximately 10 percent of patients
survive for more than 10 years. Death is usually due to respiratory
failure because of diminished strength in the skeletal muscles
responsible for breathing. Few treatment options exist for these
patients, resulting in a high unmet need for new therapies to
address functional deficits and disease progression.
About SMA
Spinal muscular atrophy (SMA) is a severe,
genetic neuromuscular disease that leads to debilitating muscle
function and progressive, often fatal, muscle weakness. It occurs
in 1 in 6,000 to 10,000 live births each year and is one of the
most common potentially fatal genetic disorders. Spinal muscular
atrophy manifests in various degrees of severity as progressive
muscle weakness resulting in respiratory and mobility impairment.
There are four types of SMA, named for age of initial onset of
muscle weakness and related symptoms: Type 1 (Infantile), Type 2
(Intermediate), Type 3 (Juvenile) and Type 4 (Adult onset). Of the
prevalent population, approximately 80% of the patients are
characterized as Type 2 and Type 3. Life expectancy and disease
severity vary by type of SMA. Type 1 patients have the worst
prognosis, with a life expectancy of no more than two years unless
treated with SMN-directed therapies; Type 2 patients have delayed
motor milestones with the most advanced milestone normally achieved
being sitting unsupported; Type 3 patients can usually stand and
walk but have increasingly limited mobility as their abilities
regress as they age; Type 4 patients may have a normal life span
but eventually suffer gradual weakness in the proximal muscles of
the extremities, eventually resulting in mobility issues. With the
recent introduction of SMN-directed therapies, it is expected that
patients may live longer, but will still have a significant need to
address ongoing disabilities related to respiration and
mobility.
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 preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3
clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next-generation cardiac myosin inhibitor, for
the potential treatment of hypertrophic cardiomyopathies (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. Cytokinetics is also
developing reldesemtiv, a fast skeletal muscle troponin activator
for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is preparing for the potential
advancement of reldesemtiv to a Phase 3 clinical trial in ALS.
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 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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