Acorda Data on Inhaled Levodopa Therapy CVT-301 Recognized in Blue Ribbon Highlights Session at International Congress of Par...
June 24 2015 - 7:01AM
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150624005376/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Apr 2023 to Apr 2024