Acorda to Discontinue Development of Dalfampridine for Treatment of Post-Stroke Walking Difficulties
November 21 2016 - 6:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the
MILESTONE clinical study did not show sufficient efficacy to
support further development of dalfampridine to improve post-stroke
walking difficulties (PSWD).
“We are disappointed by this outcome. The study indicated there
was activity related to walking in people with PSWD, as suggested
by the prior Phase 2 study, but overall this was not sufficiently
clinically meaningful. I want to express our gratitude to the study
participants, their care partners and clinicians, who gave their
time and commitment to this research,” said Ron Cohen, M.D.,
President and CEO of Acorda. “This outcome underscores the risks
that companies in the biopharmaceutical industry must take in order
to develop innovative medicines. Over the past three years, we have
successfully diversified our pipeline portfolio to account for this
risk. We plan to focus R&D resources on developing our
promising late-stage Parkinson’s disease therapies, CVT-301 and
tozadenant, as well as advancing our earlier stage assets, CVT-427
in migraine, SYN120 in Parkinson’s disease dementia, and rHIgM22 in
MS.”
As part of the PSWD development program, a multi-dose
pharmacokinetic (PK) study confirmed the Company has developed a
potentially viable once-daily (QD) formulation of
dalfampridine.
MILESTONE Efficacy and Safety Findings
The Company elected to stop enrollment and to conduct an
unblinded analysis of the MILESTONE trial after reaching enrollment
of 377 participants. This analysis included 368 participants who
received either 10 mg or 7.5 mg of dalfampridine twice daily (BID)
or placebo. The primary outcome measure of the study was the
proportion of participants who showed at least a 20% improvement on
the Two Minute Walk Test (2MinWT) at Week 12 as compared to
baseline. The 2MinWT measures the distance a subject can walk in 2
minutes, and is a validated scale used to assess walking
capacity.
The study found that 23 of 121 (19.0%) participants receiving 10
mg of dalfampridine BID and 17 of 121 (14.0%) participants
receiving 7.5 mg of dalfampridine BID showed at least a 20%
improvement on the 2MinWT, compared to 17 of 126 (13.5%)
participants receiving placebo.
In this study, dalfampridine was well tolerated in the
post-stroke population. The safety profile overall was similar to
that observed in multiple sclerosis clinical trials and
post-marketing surveillance. The most common adverse events (≥ 5%)
reported in this study were: falls (10 mg: 10.7%, 7.5 mg: 9.5%,
placebo: 5.6%), urinary tract infections (10 mg: 9.0%, 7.5 mg:
6.3%, placebo: 2.4%), dizziness (10 mg: 3.3%, 7.5 mg: 7.9%,
placebo: 2.4%) and fatigue (10mg: 2.5%, 7.5 mg: 3.2%, placebo:
6.3%). There were no seizures reported in the dalfampridine 10 mg
group. There were 2 seizures reported in the 7.5 mg group and 3
reported in the placebo group.
Additional data from the MILESTONE study will be presented at a
future medical meeting.
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 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
acquired with 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/20161121005261/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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