Data from the Phase 2b clinical trial of CVT-301, published this
week in the peer-reviewed journal Movement Disorders, showed that
people with Parkinson’s disease (PD) experiencing OFF periods and
who were treated with CVT-301 had significantly greater
improvements in motor function than those treated with placebo. A
treatment effect was evident at 10 minutes after dosing and was
sustained for at least one hour, the longest time point at which
patients were assessed.
Acorda Therapeutics, Inc. (NASDAQ:ACOR) is developing CVT-301
for the treatment of OFF periods in people with PD.
“Oral levodopa is a cornerstone of Parkinson’s disease
treatment, but after chronic therapy, approximately half of people
with PD who are treated with oral L-dopa experience OFF periods,”
said Peter LeWitt, M.D., M.Med.Sc., Director of the PD and Movement
Disorders Program at Henry Ford Hospital and lead author of the
study. “OFF periods tend to increase in frequency, severity and
duration during the course of the disease, and are among the most
challenging experiences for people with this disorder. Based on the
data from this Phase 2b clinical study, CVT-301 has the potential
to restore motor function to people with Parkinson’s disease when
they experience OFF periods, and this is now being studied in a
Phase 3 clinical trial.”
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 of oral levodopa (L-dopa) and other standard of
care medications have been optimized.
The Phase 2b trial was a randomized, double blind,
placebo-controlled, multicenter study in 86 people with PD for the
treatment of OFF periods. Participants were randomized to
self-administer CVT-301 or placebo to the lung via an inhaler, as
an adjunct to their established oral PD medications. Participants
received 35mg of CVT-301 or placebo in study weeks 1 and 2, and
50mg of drug or placebo in weeks 3 and 4.
The primary endpoint was defined as the mean change from
baseline OFF state in Unified Parkinson’s Disease Rating Scale
motor function (UPDRS Part III) score, (measured at 10-60 minutes
post dose) after 4 weeks of treatment. The UPDRS is an established
assessment method to monitor PD motor impairment that has been used
extensively in clinical research.
In this study, participants receiving CVT-301 showed a
statistically significant and clinically important reduction in
average UPDRS III score compared to placebo (p<0.01) and across
all measured time points beginning at 10 and up to 60 minutes
post-administration (p<0.05). There were no concerning safety
signals observed in either CVT-301 dose group, 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 (23% drug group; 21% placebo
group). The most common adverse events were dizziness (7% drug
group; 5% placebo), cough (7% drug group; 2% placebo) and nausea
(7% drug group; 0% placebo); there were no adverse events related
to cardiovascular or lung function. PD patients were able to
self-administer treatment while in an OFF state.
Earlier this week, data included in this paper were featured at
the 68th Annual Meeting of the American Academy of
Neurology (AAN) during the Movement Disorders Invited Science
Session. Data from the Phase 2b study were also previously
presented at the International Congress of Parkinson’s Disease and
Movement Disorders (MDS) annual meetings in 2014 and 2015. The 2015
presentation was recognized in the meeting’s Blue Ribbon Highlights
Session.
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 (PD). 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/20160420005462/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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