- SPAN-PD trial met primary endpoint:
CVT-301 showed statistically significant improvement of motor
function compared to placebo
- New Drug Application (NDA) submission
planned for Q2 2017
- Data from two long-term safety studies
expected in Q1 2017
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced Phase 3
clinical data of CVT-301, showing a statistically significant
improvement in motor function in people with Parkinson’s disease
experiencing OFF periods. CVT-301 is an investigational, inhalable
formulation of levodopa (L-dopa). It is being studied as a
treatment for OFF periods in people with Parkinson’s disease taking
an oral carbidopa / levodopa regimen. OFF periods refer to the
re-emergence of Parkinson’s symptoms.
“We are greatly encouraged by the efficacy and safety results of
this trial, which validate the positive Phase 2b results,” said
Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We would
like to express our gratitude to the study volunteers and clinical
investigators who participated in this trial to advance our
understanding of this potentially important therapy for people with
Parkinson’s.”
The SPAN-PD trial had three arms: CVT-301 84 mg and 60 mg doses
(equivalent to 50 mg and 35 mg fine particle doses, respectively),
and placebo. The primary endpoint of the study was the change at
Week 12 in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS
III) score relative to placebo at 30 minutes post-treatment for the
84 mg dose. UPDRS III change for the 84 mg dose was -9.83 compared
to -5.91 for placebo (p=0.009). UPDRS III is a validated scale,
which measures Parkinson’s motor impairment.
The safety profile of CVT-301 in this study was consistent with
that observed in the Phase 2b trial. Spirometry and diffusing
capacity of the lung for carbon monoxide (DLCO) tests showed no
notable pulmonary safety signals. The Company is currently
conducting two studies to assess the long-term safety profile of
CVT-301. Up to 12-month data from these studies are expected by the
end of the first quarter of 2017.
The Company plans to file a New Drug Application (NDA) in the
United States by the end of the second quarter of 2017, pending
results of the long-term safety studies. The Company also plans to
file a Marketing Authorization Application (MAA) in Europe by the
end of 2017, pending additional data analyses.
Peter LeWitt, M.D., M.Med.Sc., Director of the PD and Movement
Disorders Program at Henry Ford Hospital and lead
investigator of the study said, “The re-emergence of Parkinson’s
disease symptoms has a major negative impact on the lives of people
with this disease, as well as on their families and care partners.
Managing symptoms of OFF periods continues to be a significant
unmet need for people taking oral carbidopa/levodopa regimens.
Delivering levodopa by the pulmonary route offers an important
treatment option for people with Parkinson’s disease.”
Detailed trial results will be presented at a future medical
meeting.
SPAN-PD Safety Findings
Participants reporting serious adverse events (SAEs) were as
follows: 3 (2.7%) in the placebo arm, 6 (5.3%) in the 60 mg arm,
and 2 (1.8%) in the 84 mg arm. There was one death in the study, a
suicide in the 60 mg group, judged by the investigator to be not
related to study drug.
The most common adverse events that were reported in any study
arm at >5% were:
Adverse Event
n (%)
Placebo
(N=112)
CVT-301 60 mg
(N=113)
CVT-301 84 mg (N=114)
Cough 2 (1.8%) 17 (15.0%)
17 (14.9%) Upper Respiratory Tract Infection 3 (2.7%)
2 (1.8%) 7 (6.1%) Throat Irritation
0 8 (7.1%) 1 (0.9%)
Nausea 3 (2.7%) 0 6
(5.3%) Sputum Discolored 0 0
6 (5.3%)
When cough was reported, it was typically mild and reported once
per participant during the course of treatment. Three of 227
participants receiving CVT-301 discontinued the study due to
cough.
SPAN-PD Trial Design
The Phase 3, randomized, double-blind, placebo-controlled
clinical trial evaluated the efficacy and safety
of CVT-301 compared with placebo in people with
Parkinson’s who experience motor fluctuations (OFF periods). All
participants were on a stable regimen of oral carbidopa / levodopa,
and were also maintained on their other existing Parkinson’s
therapies. A total of 339 study participants were randomized and
received at least one dose of CVT-301 or placebo. Participants
self-administered treatment up to five times daily for 12
weeks.
The primary endpoint of the study was the change at Week 12 in
Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score
relative to placebo at 30 minutes post-treatment for the 84 mg
dose. Key secondary endpoints, measured at Week 12, included:
proportion of participants achieving an ON state within 60 minutes
of treatment and maintained at 60 minutes; change in UPDRS III
score at 10 and 20 minutes following treatment; Patient Global
Impression of Change (PGI-C) improvement; and total daily OFF time
as recorded in participant diary.
About Parkinson’s Disease and OFF Periods
Approximately one million people in the U.S. and 1.2 million
Europeans are diagnosed with Parkinson’s disease (PD); OFF periods
are experienced by approximately 350,000 in the U.S. and 420,000 in
Europe.
Parkinson’s is a progressive neurodegenerative disorder
resulting from the gradual loss of certain neurons responsible for
producing dopamine. It causes a range of symptoms including
impaired movement, muscle stiffness and tremors. As PD progresses,
people with Parkinson’s experience OFF periods, which are
characterized by the re-emergence of PD symptoms. This re-emergence
can occur even when an individual’s treatment regimen has been
optimized.
OFF periods can be very disruptive to the lives of people with
Parkinson’s, their families and caregivers. OFF periods can
increase in frequency and severity during the course of the
disease.
About CVT-301 and ARCUS®
CVT-301 is being developed as a self-administered, inhaled
levodopa (L-dopa) therapy for the treatment of symptoms of OFF
periods in people with Parkinson’s disease taking an oral carbidopa
/ levodopa regimen.
CVT-301 utilizes Acorda’s investigational ARCUS® platform
for inhaled therapeutics. CVT-301 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 enter the body through
the lungs and reach the brain shortly thereafter, bypassing the
digestive system.
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, 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 press 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 press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170209005506/en/
Acorda Therapeutics, Inc.Jeff Macdonald,
914-326-5232jmacdonald@acorda.com
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