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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160407005153/en/
Copyright Business Wire 2016