Results from Phase 1, Phase 2a and preclinical studies of
CVT-301, an inhaled form of levodopa, have been featured in the
current edition of Science Translational Medicine. Acorda
Therapeutics, Inc. (NASDAQ:ACOR) is developing CVT-301 for the
treatment of OFF periods in people with Parkinson’s disease
(PD).
As PD progresses, people with Parkinson’s experience OFF
periods, which are characterized by the re-emergence of PD
symptoms. These include motor symptoms such as impaired movement,
muscle stiffness, and tremor, as well as non-motor symptoms. This
re-emergence can occur even when an individual’s treatment regimen
has been optimized. OFF periods typically increase in frequency
during the course of the disease.
“OFF periods can be hugely disruptive to the lives of people
with Parkinson’s and their families, and are considered one of the
greatest unmet medical needs in the treatment of Parkinson's,” said
Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “CVT-301
is an inhaled powder form of levodopa that is being studied in
combination with standard of care Parkinson’s disease regimens.
Following two successful Phase 2 clinical trials1 ,2, our Phase 3
program is assessing the extent to which CVT-301, used when people
with Parkinson’s begin to experience OFF periods, can restore motor
function. If approved, CVT-301 may provide a valuable new treatment
option for these individuals.”
Acorda’s Phase 3 clinical program comprises a Phase 3 safety and
efficacy study as well as general and special population safety
studies. The program is designed to confirm the efficacy and safety
profile of CVT-301 and support global regulatory marketing
authorization applications. The Company expects to announce results
from its randomized, placebo-controlled Phase 3 trial in Q1
2017.
About Parkinson’s Disease and OFF Periods
There are approximately one million people in the U.S. and 1.2
million people in Europe diagnosed with Parkinson’s disease (PD).
PD is a progressive neurodegenerative disorder resulting from the
gradual loss of certain neurons responsible for producing dopamine,
which causes impairment of motor function including impaired
movement, muscle stiffness and tremors. Non-motor symptoms are also
common; they include anxiety, depression, sleep difficulties and
gastrointestinal (GI) disorders among others.
In the United States, approximately 350,000 people with
Parkinson’s experience OFF periods.
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
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 L-dopa to the lung. Oral medication can be
associated with slow and variable 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 successful results of two Phase 2 trials, Acorda
initiated a Phase 3 clinical program that includes a safety and
efficacy study as well as general and special population safety
studies. The efficacy trial has enrolled 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. The Company expects to announce
results from this study in Q1 2017.
Early CVT-301 clinical studies were funded in part by grants
from The Michael J. Fox Foundation for Parkinson’s Research.
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 a pipeline of novel neurological therapies addressing
a range of disorders, including Parkinson’s disease, post-stroke
walking difficulties (PSWD), migraine, and multiple sclerosis.
Acorda markets three FDA-approved therapies, including
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
For more information, please visit the Company’s website
at: 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; 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 (dalfampridine) Extended Release Tablets, 10 mg 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 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, any other products under development, or the
products that we will acquire when 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 presentation 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 presentation.
1 Lipp MM et al. Preclinical and clinical assessment of inhaled
levodopa for OFF episodes in Parkinson’s disease. Sci. Transl. Med.
8, 360ra136 (2016) [Online version].
2 LeWitt PA et al. Randomized Trial of Inhaled Levodopa
(CVT-301) for Motor Fluctuations in Parkinson’s Disease. Movement
Disorders 2016; 31(9): 1356-1365
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version on businesswire.com: http://www.businesswire.com/news/home/20161013005215/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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