Acorda to present additional posters on CVT-301
at AAN
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced
that data from a Phase 2b clinical trial of CVT-301 in Parkinson’s
disease (PD) will be featured during the Movement Disorders Invited
Science Session at the upcoming 68th Annual Meeting of the American
Academy of Neurology, being held in Vancouver, Canada. Invited
Science Sessions are intended to highlight cutting-edge research in
selected therapeutic categories.
“Approximately 350,000 people with PD in the U.S. experience OFF
periods, which can be very disruptive. There is a great need for
additional treatment options that improve motor function when an
OFF period occurs,” said Burkhard Blank, M.D., interim Chief
Medical Officer of Acorda. “Based on the results of the CVT-301
Phase 2b study, we initiated a Phase 3 trial to continue evaluating
the safety and efficacy of CVT-301. Inhaled levodopa, or CVT-301,
is being studied as a novel approach to treating OFF periods, which
can be one of the most challenging aspects of PD.”
Peter LeWitt, M.D., M.Med.Sc., Professor of Neurology, Wayne
State University School of Medicine, Director of the PD and
Movement Disorders Program at Henry Ford Hospital in West
Bloomfield, MI, will present, “Inhaled Levodopa (CVT-301) Provides
Rapid Improvement of OFF States in Parkinson’s Disease” as one of
six platform presentations selected for the Movement Disorders
Invited Science Session on April 19th. The data will be presented
at 4:50 p.m. Pacific time. A poster reporting on this study was
previously presented at the 19th International Congress of
Parkinson's Disease and Movement Disorders.
CVT-301 is an inhaled levodopa (L-dopa) under development for
the treatment of OFF periods in Parkinson’s disease. OFF periods
are characterized by a re-emergence of PD symptoms, including motor
symptoms such as the impaired ability to move, muscle stiffness and
tremor. This re-emergence can occur even when treatment regimens,
including oral L-dopa and other PD medications, have been
optimized.
In addition to the Invited Science Session, the Company is
presenting two posters on the CVT-301 Phase 2b trial at the
meeting:
- “Patients’ experience of Parkinson’s
disease following treatment with inhaled levodopa: results from a
phase 2b study,” (Poster #351) will be presented on April 20th from
8:30am to 7:00pm.
- “Effect of patient characteristics on
motor function in response to 35-50 mg of inhaled levodopa
(CVT-301) in patients with Parkinson's disease: results from a
phase 2b study,” (Poster #372) will be presented on April 20th from
8:30am to 7:00pm.
More detailed information on the meeting can be found on the
conference website:
https://www.aan.com/conferences/2016-annual-meeting
About CVT-301/Phase 3 Program
CVT-301 is an investigational agent being developed as a
self-administered, inhaled levodopa (L-dopa) therapy for the as
needed treatment of OFF periods in Parkinson’s disease. It is
intended for use as an adjunctive therapy to a patient’s
individually optimized oral L-dopa/carbidopa regimen.
CVT-301 utilizes Acorda’s ARCUS® platform for inhaled
therapeutics, which delivers a precise dose of a dry powder
formulation of levodopa to the lung. Oral medication can be
associated with slow onset of action, as the medicine is absorbed
through the gastrointestinal (digestive) tract before reaching the
brain. Inhaled treatments, such as those that utilize our
ARCUS technology, enter the body through the lungs and reach the
brain shortly thereafter, bypassing the digestive system.
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 Unified Parkinson’s Disease Rating
Scale Part 3 (UPDRS III) after administration of CVT-301 in
patients experiencing an OFF period (30 minutes post dose). UPDRS
III is an established scale to monitor PD motor impairment, and is
considered a standard in the field.
More details about the study, including enrollment criteria, can
be found at https://cvt301.acordatrials.com/en/patient/ 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 has an industry leading pipeline of novel neurological
therapies addressing a range of disorders, including Parkinson’s
disease, epilepsy, post-stroke walking deficits, migraine, and
multiple sclerosis. Acorda markets three FDA-approved
therapies, including AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg.
For more information, please visit www.acorda.com.
Forward-Looking Statement
This press release includes forward-looking statements. 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 complete the Biotie
transaction on a timely basis or at all; the ability to realize the
benefits anticipated from the Biotie and Civitas transactions,
among other reasons because acquired development programs are
generally subject to all the risks inherent in the drug development
process and our knowledge of the risks specifically relevant to
acquired programs generally improves over time; the ability to
successfully integrate Biotie’s operations and Civitas’ operations,
respectively, into our operations; we may need to raise additional
funds to finance our expanded operations and may not be able to do
so on acceptable terms; 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 (diazepam) Nasal Spray, 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, any other products under development, or the products that
we would acquire if we complete the Biotie transaction; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain and maintain regulatory approval of
or to successfully market Fampyra outside of the U.S. and our
dependence on our collaborator 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 our
filings with the Securities and Exchange Commission. We may
not actually achieve the goals or plans described in our
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 we disclaim
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/20160407005153/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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