Adamas Completes Enrollment of Its Phase 3 EASE LID 3 Study Evaluating ADS-5102 for Treatment of Levodopa-Induced Dyskinesia ...
December 14 2015 - 4:05PM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the
completion of enrollment in its Phase 3 EASE LID 3 study.
EASE LID 3 is a clinical trial designed to evaluate the efficacy
and safety of ADS-5102 for the treatment of levodopa-induced
dyskinesia (LID), a motor complication associated with the
treatment of Parkinson’s disease.
“We are pleased to have completed enrollment of EASE LID 3, our
third randomized clinical study in this indication, and we expect
to maintain momentum in advancing our ADS-5102 program for the
treatment of LID,” said Gregory T. Went, Ph.D., Chairman and Chief
Executive Officer of Adamas Pharmaceuticals, Inc. “We look forward
to announcing top-line data from the EASE LID and EASE LID 3 trials
in the near future and being one step closer to a potential new
treatment option for Parkinson’s patients experiencing the often
debilitating effects of levodopa-induced dyskinesia.”
EASE LID 3, which enrolled 77 patients, is a 13-week
multi-center, randomized, double-blind, placebo-controlled study
assessing the efficacy of a 340 mg dose of ADS-5102 administered
once daily at bedtime. The primary endpoint of EASE LID 3 is a
reduction in dyskinesia assessed by changes in Unified Dyskinesia
Rating Scale (UDysRS) from baseline to week
12.Comprehensive Phase 3 ProgramAdamas has three
ongoing clinical trials of ADS-5102 for the treatment of LID in
individuals with Parkinson’s disease. These clinical trials, which
were initiated following the completion of a Phase 2/3 study,
include two Phase 3 trials and one open-label safety study.
Completed Phase 2/3 Trial
- EASED, a randomized, placebo-controlled, multi-center study,
evaluated patients with Parkinson’s disease experiencing
troublesome LID. Patients were randomized to receive placebo or to
one of three dose levels of ADS-5102. As previously reported,
ADS-5102 at 340 mg/day significantly reduced LID as measured by
change in UDysRS over eight weeks versus placebo (primary endpoint,
p=0.005). Data also suggested that ADS-5102 was generally well
tolerated and reported adverse events were consistent with
Parkinson’s disease and the known amantadine safety profile.
Ongoing Phase 3 Studies
- EASE LID, a confirmatory Phase 3 study, enrolled approximately
120 patients. The 26-week multi-center, randomized, double-blind,
placebo-controlled study will assess the efficacy of a 340 mg dose
of ADS-5102 administered once daily at bedtime. The primary
endpoint of EASE LID is a reduction in dyskinesia assessed by
changes in UDysRS at week 12.
- EASE LID 3, a confirmatory Phase 3 study, as described
above.
- EASE LID 2, an open-label safety study, which is open to
patients from EASED, EASE LID and EASE LID 3, as well as LID
patients who have undergone deep brain stimulation.
Parkinson’s Disease and Levodopa-induced
Dyskinesia Parkinson's disease is a chronic, progressive
motor disorder that causes a variety of symptoms, such as tremors,
rigidity, slowed movements and postural instability. The most
commonly prescribed treatments for Parkinson’s disease are
levodopa-based therapies. In the body, levodopa is converted to
dopamine to replace the dopamine loss caused by the disease.
Patients initially receive relief from symptoms of Parkinson’s
disease for much of the day. This period of relief is known as ON
time. As the effects of levodopa wear off, the symptoms of
Parkinson’s disease return. This is known as OFF time.As
Parkinson’s disease progresses, most patients require increasing
doses of levodopa to achieve equivalent therapeutic benefit.
Patients may also experience symptoms of their disease upon waking,
prior to the first dose of levodopa taking effect. Over time many
patients will suffer from levodopa-induced dyskinesia, a condition
characterized by involuntary movements without purpose. LID can
become severely disabling, rendering patients unable to perform
routine daily tasks. As Parkinson’s disease advances, the symptoms
of LID often worsen in frequency and severity. Eventually the total
time that a patient spends ON with LID can become a significant
portion of his or her day.About ADS-5102Adamas’
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 for the treatment of levodopa-induced
dyskinesia associated with Parkinson’s disease and 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 PharmaceuticalsAdamas
Pharmaceuticals, Inc. is driven to improve the lives of those
affected by chronic disorders of the central nervous system. Adamas
is currently developing ADS-5102, its lead wholly-owned product
candidate, for the treatment of levodopa-induced dyskinesia
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 contained in this press
release such as expectations regarding the potential for ADS-5102
in levodopa-induced dyskinesia, the progress associated with our
clinical trials and the potential results from our EASE LID and
EASE LID 3 studies. 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,” ”will,” “expect,” “anticipate,” “estimate,” “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 relating to research, clinical and
development activities of ADS-5102, challenges associated with
clinical trials including delays in completion of our studies, and
failure to demonstrate safety and efficacy of ADS-5102, as well as
risks relating to Adamas’ business in general, see Adamas’ Annual
Report on Form 10-Q filed with the Securities and Exchange
Commission on November 12, 2015. Investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Adamas undertakes no
obligation to update any forward-looking statement in this press
release.
For questions, please contact:
Julie Wood
Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
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