Adamas to Present New ADS-5102 Data from Phase 2 Trial in Walking Impairment Associated with Multiple Sclerosis at ACTRIMS F...
February 17 2017 - 8:00AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) will present results
from its Phase 2 proof-of-concept study of ADS-5102 (amantadine
hydrochloride) extended-release capsules for the treatment of
walking impairment in patients with multiple sclerosis (MS) at the
Americas Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2017. In the study, patients on ADS-5102 showed an
approximate 17 percent placebo-adjusted improvement in walking
speed in the Timed 25 Foot Walk (T25FW) test (p<0.05) and an
approximate three second placebo-adjusted improvement in the Timed
Up and Go (TUG) test (p<0.10). In addition, ADS-5102 was
generally well tolerated.
“This Phase 2 proof-of-concept study of ADS-5102 has generated
encouraging data across several performance measures in multiple
sclerosis patients,” said Rajiv Patni, M.D., chief medical officer
of Adamas. “If these data are confirmed in longer duration,
controlled clinical trials, ADS-5102 may offer an additional
treatment option for multiple sclerosis patients experiencing
impairments in walking ability, which are issues that a large
number of patients with multiple sclerosis confront.”
Phase 2 Proof-of-Concept Study Design and
ResultsThe multi-center, randomized, double-blind,
placebo-controlled Phase 2 study was designed to evaluate ADS-5102
in MS patients with walking impairment for four weeks. The study
enrolled 60 MS patients who had impaired walking speed at baseline.
The primary study objective was to evaluate the safety and
tolerability of 340 mg ADS-5102 dosed once daily at bedtime.
Exploratory efficacy analyses included the change from baseline to
week four in the T25FW, the TUG, the 2 Minute Walk Test (2MWT) and
the Multiple Sclerosis Walking Scale-12 (MSWS-12). Other outcome
measures included assessments of fatigue, cognition and depression.
Background MS medications were not changed during the course of the
study.
Efficacy results were obtained from a modified intent-to-treat
population that included 56 subjects who received at least one dose
of ADS-5102 and provided at least one post-baseline walking
assessment. An analysis using the mean changes from baseline to
week four efficacy measures showed an approximate 17 percent
placebo-adjusted improvement in walking speed in the T25FW test
(p<0.05) and an approximate three second placebo-adjusted
improvement in TUG (p<0.10). No effects were noted for fatigue,
cognitive dysfunction or depression.
ADS-5102 was generally well tolerated in this study population.
One serious adverse event was reported in the study, suspected
serotonin syndrome, reported as drug related by an investigator.
The most frequent adverse events (AEs) reported in the ADS-5102
treatment group were dry mouth, constipation and insomnia. Five
ADS-5102 patients and no placebo patients discontinued treatment
due to AEs.
Details on Presentation at ACTRIMSDr. Jeffrey
Cohen, professor of neurology and director of the Cleveland
Clinic’s Mellen Center for Multiple Sclerosis Treatment and
Research, will present the findings from this study during a poster
session at the ACTRIMS Forum in Orlando, Fla.
|
|
Poster Title: |
A Phase 2
Study of ADS-5102 (amantadine hydrochloride) Extended Release
Capsules in Multiple Sclerosis Patients with Walking
Impairment |
Poster Number: |
P207 |
Date: |
Thursday,
February 23, 2017 |
Time: |
7:00 –
9:00 p.m. |
|
|
About ADS-5102 ADS-5102 is a chrono-synchronous
amantadine therapy with potential applications across a number of
chronic neurologic disorders. Adamas is focusing initial
development on the treatment of levodopa-induced dyskinesia (LID)
in patients with Parkinson’s disease. A New Drug Application (NDA)
supporting ADS-5102 for the treatment of LID in patients with
Parkinson’s disease is under review by the FDA, with a Prescription
Drug User Fee Act (PDUFA) date of August 24, 2017. The Company is
also investigating ADS-5102 for the treatment of walking impairment
in multiple sclerosis patients and is considering developing it for
other indications in Parkinson’s disease earlier in the treatment
journey.
About Multiple Sclerosis and Walking
Impairmenti Multiple sclerosis is a chronic
autoimmune-mediated disorder that affects more than 2 million
people worldwide and 400,000 people in the United States, where
there are approximately 270,000 diagnosed and treated patients.
Multiple sclerosis manifests as unpredictable symptoms that can
vary in severity and tend to progress over years, in some cases to
near total disability. Walking impairment, which affects
approximately 80 percent of diagnosed patients, is associated with
an increased risk of falls and has a substantial impact on daily
activities. Despite therapeutic advances, unmet medical needs
remain for MS patients with walking impairment, including the need
for a therapeutic agent that delivers an improvement in walking
ability during the day.
About Adamas Pharmaceuticals, Inc.Adamas is
developing new medicines to improve the daily lives of those
affected by chronic neurologic disorders, including Parkinson's
disease, multiple sclerosis, epilepsy and Alzheimer's disease.
Adamas has pioneered a platform to develop medicines, called
chrono-synchronous therapies, for chronic neurologic disorders
based on an understanding of the time-dependent biologic processes
responsible for disease activity and drug response to potentially
achieve symptomatic relief without tolerability issues. The
company’s most advanced product candidate, ADS-5102, is in
development for levodopa-induced dyskinesia (LID) in patients with
Parkinson’s disease and for walking impairment in patients with
multiple sclerosis. An NDA supporting ADS-5102 for the treatment of
LID in patients with Parkinson’s disease is under review by the
FDA, with a PDUFA date of August 24, 2017. Adamas is exploring
other indications for ADS-5102 for further development. Adamas is
also investigating ADS-4101 for the treatment of partial onset
seizures in patients with epilepsy. Additionally, Adamas’ licensed
assets, NAMENDA XR® and NAMZARIC®, are currently marketed by
Allergan, and Adamas is eligible to receive royalties on sales of
these medicines beginning in June 2018 and May 2020, respectively.
For more information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz Pharma GmbH
& Co. KGaA.
Forward-looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not
limited to, statements contained in this press release regarding
the potential approval and commercialization of ADS-5102 for
treatment of levodopa-induced dyskinesia in patients with
Parkinson's disease, a potential registration program for ADS-5102
for treatment of walking impairment in MS, additional indications
for ADS-5102, and additional products such as ADS-4101. Words such
as "will," "may," "potential," and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. For a
description of risks and uncertainties that could cause actual
results to differ from those expressed in forward-looking
statements, including risks relating to our research, clinical and
development activities relating to ADS-5102 and ADS-4101, the
regulatory and competitive environment and our business in general,
see Adamas Pharmaceuticals’ most recent Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on November
3, 2016. Investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this release. Adamas Pharmaceuticals undertakes no obligation to
update any forward-looking statement in this press release.
i Noonan et al 2002; Coleman 2013; Evaluate Pharma
2016.
Contact:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3528
ir@adamaspharma.com
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