Adamas Presents Nonclinical Findings Supporting the Potential Use of ADS-5102 for the Treatment of Multiple Sclerosis Gait
October 12 2015 - 4:00PM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced findings
from two nonclinical studies that demonstrate the potential of
ADS-5102 for the treatment of multiple sclerosis (MS) symptoms. One
study demonstrated improvement in walking in in vivo models of MS.
Data from the second study provide insights into the potential
mechanisms of action of amantadine in MS. These results (Abstract
P863) were presented at the 31st Congress of the European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in
Barcelona, Spain.
“We are encouraged by these nonclinical data and
what they mean with respect to the potential of ADS-5102, our
extended release version of amantadine, in addressing MS-related
symptoms, including walking impairment,” stated Natalie McClure,
Ph.D., Senior Vice President of Product Development at Adamas
Pharmaceuticals, Inc. “With the improved pharmacokinetic
profile of ADS-5102, we can potentially administer higher
therapeutic doses than is common with immediate release
amantadine.”
Researchers conducted nonclinical studies designed
to evaluate the efficacy of amantadine for the treatment of
MS-related symptoms, including walking impairment, in in vivo
models of MS and to better understand the mechanisms of action of
amantadine in MS. Data demonstrated that in models of MS, chronic
administration of amantadine at a dose intended to match the human
plasma levels of ADS-5102 improved walking. Additionally, data from
an in vitro study demonstrated that amantadine blocked neuronal
potassium channel activity, which may result in enhanced electrical
impulses across demyelinated regions of neurons. Data from these
studies suggest that ADS-5102 may have clinical utility in the
treatment of major symptoms associated with MS, including walking
impairment.
In June 2015, Adamas announced the initiation of a
Phase 2 clinical trial of ADS-5102 for the treatment of major
symptoms associated with multiple sclerosis in patients with
walking impairment. The study, which will enroll approximately 60
patients, is designed to evaluate the safety and tolerability of
ADS-5102 dosed at 340 mg once daily at bedtime in an MS population.
Efficacy measurements include assessments of walking and
fatigue. The treatment duration is four weeks with top-line
results anticipated in 2016.
About MS
MS is a chronic autoimmune-mediated disorder that
affects approximately 270,000 people in the United States.
While there are multiple drugs approved to reduce
inflammation and slow the development of symptoms early in the
disease course, there are limited options available for the
treatment of the frequent and often persistent neurological
symptoms. In a 2013 patient survey on MS in America, 76
percent of respondents reported walking difficulties and 89 percent
reported fatigue.
About ADS-5102
Adamas’ most advanced wholly-owned product
candidate is ADS-5102 (amantadine HCl), an extended-release version
of amantadine that is intended for once daily administration at
bedtime. ADS-5102 is designed to improve upon the pharmacokinetic
(PK) profile of immediate release amantadine, with the aim of
enhancing efficacy without compromising the known tolerability
profile. In PK studies, ADS-5102 has been shown to achieve high
plasma amantadine concentrations in the early morning that are
sustained throughout the afternoon and are lower in the evening,
potentially providing therapeutic benefit when needed most.
Adamas is currently evaluating ADS-5102 in Phase 3 clinical
trials for the treatment of levodopa-induced dyskinesia (LID)
associated with Parkinson’s disease and in a Phase 2 clinical trial
for the treatment of major symptoms associated with multiple
sclerosis in patients with walking impairment. There are currently
no approved drugs in the United States or Europe for the treatment
of LID.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty
pharmaceutical company driven to improve the lives of those
affected by chronic disorders of the central nervous system. The
company seeks to achieve this by modifying the pharmacokinetic
profiles of approved drugs to create novel therapeutics for use
alone and in fixed-dose combination products. Adamas is currently
developing ADS-5102, its lead wholly-owned product candidate, for
the treatment of levodopa-induced dyskinesia (LID) associated with
Parkinson's disease and for the treatment of major symptoms
associated with multiple sclerosis in patients with walking
impairment. The company's portfolio also includes Namzaric™ and
Namenda XR®, two approved products with Forest Laboratories
Holdings Limited, an indirect wholly-owned subsidiary of Allergan
plc. Forest is responsible for marketing both products in the
United States under an exclusive license from Adamas. For
more information, please visit www.adamaspharma.com.
Namzaric™ is a trademark of Merz Pharma GmbH &
Co. KGaA.
Namenda XR® is a registered trademark of Merz
Pharma GmbH & Co. KGaA
Statements 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 regarding the potential application and ongoing
development of ADS-5102 for multiple sclerosis (MS) symptoms as
well as progress and timelines associated with our clinical trials.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Words such as “may,”
“can,” “plan,” “will,” “expect,” “anticipate,”
“intend,” and similar expressions (as well as other words or
expressions referencing future events, conditions, or
circumstances) are intended to identify forward-looking statements.
For a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in
forward-looking statements, including risks associated with
research and development activities of ADS-5102, including
challenges and delays associated with clinical studies, regulatory
review and requirements, as well as risks relating to Adamas’
business in general, see Adamas’ Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on August 11,
2015.
For questions, please contact:
Julie Wood
Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
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