Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced
that the first patient has been enrolled in a Phase 3 study of
CVT-301 for the treatment of OFF episodes in Parkinson’s disease
(PD). OFF episodes are characterized by a re-emergence of PD
symptoms such as tremor, muscle stiffness and impaired ability to
move.
CVT-301 is a novel, self-administered inhaled therapy designed
to provide rapid, reliable delivery of a precise dose of levodopa
(L-dopa) through the lungs to return people with PD to an ON state.
An ON state is when a patient’s symptoms are adequately controlled,
allowing people with Parkinson’s to more readily perform daily
activities.
“Parkinson’s is a debilitating neurological disease affecting
over a million Americans, and as many as 10 million people
worldwide,” said Enrique Carrazana, M.D., Acorda Therapeutics’
Chief Medical Officer. “About 350,000 people with PD in the U.S.
experience OFF episodes, which can be exceptionally disruptive,
impacting their lives on a daily basis, even multiple times per
day. We believe CVT-301 has the potential to be an important
treatment for people experiencing OFF episodes.”
The multi-center, double blind, randomized trial is expected to
enroll approximately 345 participants across three arms: 50mg,
35mg, or placebo. These are the same doses used in the Phase 2b
study. The primary outcome measure is improvement on the Unified
Parkinson’s Disease Rating Scale (UPDRS) Part III after
administration of CVT-301.
More details about the study, including enrollment criteria, can
be found at www.acorda.com or
http://clinicaltrials.gov/ct2/show/NCT02240030?term=CVT-301&rank=2
Phase 2b Study Results
Positive results from the CVT-301 Phase 2b study were presented
at the 2014 American Academy of Neurology Annual Meeting. In this
study, participants receiving CVT-301 showed a statistically
significant and clinically important reduction in average UPDRS
Part III motor score versus placebo across time points beginning at
10 and up to 60 minutes post-administration (p < 0.001). Both
doses of CVT-301 were well tolerated, with no increase relative to
placebo in troublesome or non-troublesome dyskinesias during ON
periods. There were no serious adverse events in the trial, and the
incidence of drug-related adverse events was similar between
treatment groups. The CVT-301 inhaler was shown to be easily
self-administered in the OFF state.
“Oral L-dopa is the standard of care in reducing the symptoms of
PD; however, significant challenges remain in creating an
individualized treatment regimen that consistently maintains
therapeutic effects as the disease progresses,” said Rick Batycky,
Ph.D., Acorda Therapeutics’ Chief Technology Officer. “CVT-301 uses
our proprietary ARCUS technology to deliver L-dopa through the
lungs. The ARCUS technology can deliver much larger doses than is
possible with standard pulmonary technologies, making it ideal for
delivery of medications such as L-dopa.”
About ARCUS® Technology
Acorda’s proprietary ARCUS technology platform is a dry-powder
pulmonary delivery system that has potential applications in
multiple disease areas. This platform allows consistent and
precise delivery of significantly larger doses of medication than
are possible with conventional pulmonary systems. The ARCUS inhaler
is breath-actuated, operated by the user putting their lips to the
device and simply breathing in.
The ARCUS technology has been used to successfully deliver more
than one million doses to patients in clinical trials of various
products. CVT-301 is the most advanced drug candidate using the
ARCUS technology. Acorda has an extensive patent portfolio relating
to CVT-301 and the ARCUS technology, which covers aspects of the
formulated drug product, the inhaler, the method of drug delivery
and manufacturing processes for CVT-301.
About Parkinson’s Disease (PD) and OFF Episodes
Approximately one million Americans, 1.2 million Europeans and
between seven and ten million people worldwide suffer from PD. PD
is a progressive neurodegenerative disorder resulting from the
gradual loss of certain neurons responsible for producing dopamine,
which causes impairment of motor function including tremors, muscle
stiffness and impaired ability to move. The standard of care for
the treatment of PD symptoms is oral levodopa (L-dopa).
Approximately 70% of people with PD in the United States are
treated with oral L-dopa. Effective control of PD symptoms is
referred to as an ON state.
As Parkinson’s disease progresses, even optimized regimens of
oral L-dopa are associated with increasingly wide variability in
the timing and amount of absorption into the bloodstream. This
results in the unreliable control of symptoms, leading to OFF
episodes, or motor fluctuations. OFF episodes, which are
characterized by a re-emergence of PD symptoms, increase in
frequency and severity during the course of the disease. About half
of people with PD experience OFF episodes within five years of
initiating oral L-dopa therapy, and about 350,000 people with PD in
the U.S. alone experience OFF episodes. OFF episodes are
inadequately addressed by available therapies and are considered
one of the greatest unmet medical needs facing people with PD.
About CVT-301
CVT-301 is being developed as a self-administered, inhaled
L-dopa therapy for treatment of OFF episodes in Parkinson’s disease
(PD). This is an adjunctive therapy to a patient’s individually
optimized oral L-dopa regimen. Acorda’s proprietary ARCUS®
technology provides a precise dose of a dry powder formulation of
L-dopa to the lung to enable rapid and predictable absorption.
CVT-301 is delivered through a pocket-size, breath-actuated inhaler
designed to be patient-friendly. In the Phase 2b clinical trial,
participants receiving CVT-301 showed a statistically significant
and clinically important reduction in average UPDRS Part III motor
score versus placebo across time points beginning at 10 and up to
60 minutes post-administration (p < 0.001). Both doses of
CVT-301 were well-tolerated, with no increase relative to placebo
in troublesome or non-troublesome dyskinesias during ON periods.
There were no serious adverse events reported in people receiving
CVT-301. In the CVT-301 treatment group, lightheadedness and cough
were the most frequently reported adverse events. There were no
observed, treatment-associated adverse effects on lung function.
Clinical studies conducted to date have been funded in part by
grants from The Michael J. Fox Foundation for Parkinson’s
Research.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a
biotechnology company focused on developing therapies that restore
function and improve the lives of people with neurological
disorders.
Acorda markets three FDA-approved therapies, including
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a
treatment to improve walking in patients with multiple sclerosis
(MS), as demonstrated by an increase in walking speed. The Company
has one of the leading pipelines in the industry of novel
neurological therapies. Acorda is currently developing a number of
clinical and preclinical stage therapies. This pipeline addresses a
range of disorders including post-stroke walking deficits,
Parkinson’s disease, epilepsy, neuropathic pain, heart failure, MS,
and spinal cord injury.
For more information, please visit the Company’s website
at: www.acorda.com.
Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts,
regarding management's expectations, beliefs, goals, plans or
prospects should be considered forward-looking. These statements
are subject to risks and uncertainties that could cause actual
results to differ materially, including the ability to realize the
benefits anticipated from the Civitas transaction and to
successfully integrate Civitas' operations into our operations; our
ability to successfully market and sell Ampyra in the U.S.; third
party payers (including governmental agencies) may not reimburse
for the use of Ampyra or our other products at acceptable rates or
at all and may impose restrictive prior authorization requirements
that limit or block prescriptions; the risk of unfavorable results
from future studies of Ampyra or from our other research and
development programs, including CVT-301, Plumiaz, or any other
acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully
market CVT-301, Plumiaz, or any other products under development;
we may need to raise additional funds to finance our expanded
operations and may not be able to do so on acceptable terms; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain regulatory approval of or to
successfully market Fampyra outside of the U.S. and our dependence
on our collaboration partner Biogen Idec in connection
therewith; competition; failure to protect our intellectual
property, to defend against the intellectual property claims of
others or to obtain third party intellectual property licenses
needed for the commercialization of our products; and, failure to
comply with regulatory requirements could result in adverse action
by regulatory agencies.
These and other risks are described in greater
detail in Acorda Therapeutics' filings with
the Securities and Exchange Commission. Acorda may not
actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this release are made only as of the date hereof, and Acorda
disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this release.
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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