ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that data from a
Phase 2b clinical trial of CVT-301, an inhaled levodopa (L-dopa) under
development for the episodic treatment of OFF episodes associated with
Parkinson’s disease (PD), was included in the Blue Ribbon Highlights
Session of the 19th International Congress of Parkinson’s Disease and
Movement Disorders (MDS). Selected by a panel of experts, the Blue
Ribbon Highlights Session provided a critical review of the best poster
presentations, highlighting relevance, novelty and quality of both
clinical data and basic research. “Inhaled Levodopa (CVT-301) Provides
Rapid Improvement of OFF States in Parkinson’s Disease” was one of only
19 posters selected from among the almost 1,500 poster presentations at
this year’s conference.
OFF episodes are characterized by a re-emergence of PD motor symptoms,
such as impaired ability to move, muscle stiffness and tremor. The trial
showed that patients experiencing an OFF episode, treated with CVT-301,
showed significantly greater improvements in motor function than
patients treated with inhaled placebo; the difference in improvement
were already apparent 10 minutes after dosing and were durable for at
least an hour, the longest time point at which they were measured.
“As their condition progresses, the majority of people with Parkinson’s
disease will experience OFF episodes while using oral levodopa, which is
the gold standard of care,” said Enrique Carrazana, M.D., Chief Medical
Officer of Acorda. “In clinical trials, CVT-301 has demonstrated the
potential to reduce the duration of OFF episodes in people taking oral
L-dopa. Improvements in motor function could be seen within 10 minutes
of administration. We have initiated a Phase 3 trial to further develop
this promising therapy, so that it can potentially benefit people with
Parkinson’s who need new and effective treatment options for OFF
episodes.”
The poster was also chosen by the MDS Congress Scientific Program Chairs
for a Guided Poster Tour Presentation.
Safety and Efficacy Finding
The primary endpoint of the Phase 2b trial was defined as the mean
change from baseline in Unified Parkinson’s Disease Rating Scale Part 3
(UPDRS III) score after 4 weeks of treatment (10-60 minutes post dose).
UPDRS III is an established scale to monitor PD motor impairment, and is
considered a standard in the field.
In this study, participants receiving CVT-301 showed a statistically
significant and clinically important reduction in average UPDRS III
motor score compared to placebo (p<0.01) across all measured time points
beginning at 10 and up to 60 minutes post-administration (p < 0.05).
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 the drug group, and the
incidence of drug-related adverse events was similar between treatment
groups. The most common adverse events were dizziness, headache and
cough; there were no adverse events on cardiovascular or lung function.
PD patients were able to self-administer treatment while in an OFF state.
About CVT-301 Phase 3 Program
Based on the results of the Phase 2b trial, Acorda has initiated a Phase
3 clinical trial that 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 UPDRS 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
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. 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 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.
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Source: Acorda Therapeutics