Acorda Therapeutics, Inc. (Nasdaq:ACOR) today presented 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). 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 was already apparent 10 minutes after dosing and was
durable for at least an hour, the longest time point at which
patients were measured. These data were presented at the 19th
International Congress of Parkinson's Disease and Movement
Disorders (MDS) in San Diego, CA.
“Oral levodopa, or L-dopa, is the current gold standard of care
for Parkinson’s disease. However, as the disease progresses, the
majority of people will experience OFF episodes, even while on
L-dopa therapy,” said Enrique Carrazana, M.D., Chief Medical
Officer of Acorda. “Based on the successful results of this study,
we have initiated a Phase 3 clinical and a long-term safety trial
to further assess the potential of CVT-301 to reduce the duration
of OFF episodes in people taking oral L-dopa. We believe that if
successful, these results, together with the existing Phase 2b
data, will enable Acorda to file a New Drug Application with the
FDA.”
The Phase 2b trial was a randomized, double blind,
placebo-controlled, multicenter study in 86 people with PD for the
treatment of OFF episodes. Participants were randomized to
self-administer CVT-301 or placebo as an adjunct to oral PD
medications. Participants received 35mg of CVT-301 or placebo
delivered to the lung in weeks 1 and 2, and 50mg of drug or placebo
delivered to the lung in weeks 3 and 4. In-office assessments of
the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III)
were performed at weeks 1, 2 and 4. The primary endpoint was
defined as the mean change from baseline in UPDRS III score (10-60
minutes post dose) after 4 weeks of treatment. 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) and
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.
“OFF episodes have a major negative impact on the lives of
people with Parkinson’s disease, as well as on their loved ones and
care partners. Effective treatment options are desperately needed,”
said Robert Hauser, M.D., Professor of Neurology, Molecular
Pharmacology and Physiology at the University of South Florida and
one of the authors of the poster. “The study results reported today
indicate that patients treated with CVT-301 had rapid, clinically
meaningful improvements in motor function. This suggests CVT-301
has the potential to be an exciting new therapy to treat OFF
episodes in people with Parkinson’s. I am looking forward to the
results of the ongoing clinical studies, which are designed to
provide confirmatory information about the safety and efficacy of
CVT-301 in treating OFF episodes.”
The poster was chosen by the MDS Congress Scientific Program
Chairs for a Guided Poster Tour Presentation. The poster is also
under consideration for inclusion in the Blue Ribbon Highlights
session, which will provide a critical overview of the best
presentations highlighting the relevance, novelty and quality of
both clinical and basic research.
Data from this study were presented at the 2014 American Academy
of Neurology Annual Meeting and the 18th International Congress of
Parkinson's Disease and Movement Disorders.
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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version on businesswire.com: http://www.businesswire.com/news/home/20150616005425/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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