-- Results presented in oral platform and poster
sessions at the 69th American Academy of Neurology (AAN)
Annual Meeting --
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the
presentation of two separate analyses of pooled data from the
placebo-controlled Phase 3 clinical trials of ADS-5102 (amantadine)
extended-release capsules in oral platform and poster presentation
sessions at the 69th American Academy of Neurology (AAN) Annual
Meeting in Boston. The pooled data results, which are consistent
with the original findings from EASE LID and EASE LID 3,
demonstrated that people with Parkinson's disease treated with
ADS-5102 had a significant reduction in levodopa-induced dyskinesia
(LID), as measured by the Unified Dyskinesia Ratings Scale
(UDysRS), and showed statistically significant reduction in OFF
time, as reported by Parkinson’s disease home diary data.
“Adamas is excited to present this important
research at the AAN Annual Meeting,” stated Gregory T. Went, Ph.D.,
Chairman and Chief Executive Officer of Adamas Pharmaceuticals,
Inc. “We continue to be highly-encouraged by the strength and
consistency of the ADS-5102 data, as we believe it demonstrates
that ADS-5102, if approved, has the potential to be an important
new treatment for people with Parkinson’s disease. Given the
upcoming PDUFA date for ADS-5102, our company is now at an
important inflection point; we look forward to making this
treatment available for patients and creating value for all Adamas
shareholders.”
Oral Platform Presentation (Primary
Endpoint)Pooled Analysis of Phase 3 Studies of ADS-5102
(amantadine) Extended-Release Capsules for Levodopa-Induced
Dyskinesia: A Detailed Review of UDysRS Results
The UDysRS data from EASE LID and EASE LID 3
were pooled in a pre-specified analysis. The UDysRS included both
physician assessments and historical patient assessments. The
pooled ADS-5102 UDysRS results showed a significant, rapid and
durable reduction in LID versus placebo:
- At Week 12, the UDysRS total score was -17.7 in the ADS-5102
group versus -7.6 in the placebo group (p<0.0001) – an
improvement in the UDysRS total score of approximately 30 percent
among those treated with ADS-5102 compared to placebo treated
patients.
- For any change from baseline in UDysRS total score, a greater
proportion of patients taking ADS-5102 showed a reduction compared
to placebo.
- Treatment effects were comparable in both the objective
(physician-assessed) and historical (patient-reported) UDysRS
scores, and reductions were significantly greater with ADS-5102
than with placebo (p<0.0001 for both).
“The magnitude of the reduction of LID, as well
as the significant reduction in OFF time, demonstrated with
ADS-5102 treatment is an important advancement in the management of
Parkinson’s disease,” said Rajesh Pahwa, M.D., Laverne & Joyce
Rider Professor of Neurology and Director of the Parkinson's
Disease and Movement Disorder Center at the University of Kansas
Medical Center. “To my knowledge, ADS-5102 is the first and only
medicine to provide both of these benefits to patients on levodopa
therapy. As a result, patients treated with ADS-5102 in the Phase 3
studies gained approximately four hours of ON time without
troublesome dyskinesia daily.”
Poster Presentation (Secondary
Endpoints)Pooled Analysis of Phase 3 Studies of ADS-5102
(amantadine) Extended-Release Capsules for Levodopa-Induced
Dyskinesia: A Detailed Review of PD Home Diary Results
Parkinson’s disease home diary data from the
ADS-5102 Phase 3 EASE LID and EASE LID 3 studies were pooled to
summarize the results of the secondary endpoints of ON time without
troublesome dyskinesia, ON time with troublesome dyskinesia and OFF
time. Results showed that patients treated with ADS-5102 reported a
clinically meaningful increase in ON time without troublesome
dyskinesia, due to significant reductions in both ON time with
troublesome dyskinesia and OFF time, at 12 weeks compared to
placebo:
- Treatment with ADS-5102 improved ON time without troublesome
dyskinesia by approximately 40 percent compared to placebo
(p<0.0001), which represents a 2.4 hour per day increase in ON
time without troublesome dyskinesia.
- Treatment with ADS-5102 decreased OFF time by approximately 45
percent compared to placebo (p=0.0006), which represents a 1 hour
per day decrease in OFF time.
- The treatment effect of ADS-5102 on OFF time was consistent
across subgroups, including baseline OFF severity.
Additional analyses of the pooled Parkinson’s
disease home diary data showed that among ADS-5102 treated
patients, 52 percent reported complete resolution (0 hours) of ON
time with troublesome dyskinesia compared to 23 percent of placebo
treated patients. Also, these analyses showed that among ADS-5102
treated patients, 68 percent reported marked improvement (>2
hours) in ON time without troublesome dyskinesia compared to 40
percent of placebo treated patients.
“The pooled analysis of the key secondary
endpoints, Parkinson’s disease home diary data from patients
treated with ADS-5102, is consistent with the ADS-5102 primary
UDysRS results and these complementary findings are clinically
meaningful. Two of the most troublesome motor problems experienced
by people with Parkinson’s disease – levodopa induced dyskinesia
and OFF time – were both improved,” said Caroline M. Tanner, M.D.,
Ph.D., Director of the Parkinson's Disease Research, Education and
Clinical Center at the San Francisco Veterans Affairs Medical
Center and professor in residence in the Department of Neurology at
the University of California, San Francisco. “Also, the additional
analysis showing that more than half of Phase 3 study participants
treated with ADS-5102 had complete resolution of ON time with
troublesome dyskinesia, compared to fewer than one-fourth of those
in the placebo group, is compelling.”
In the Phase 3 EASE LID and EASE LID 3 studies,
the most common adverse events were consistent with the known
amantadine safety profile, and most occurred between Weeks 2-4 of
treatment. The majority (84 percent) of ADS-5102 treated patients
did not discontinue study drug due to adverse reactions. The most
common adverse reactions (≥5 percent in the active group) were
visual hallucinations, dry mouth, dizziness, peripheral edema,
falls, constipation, nausea, anxiety, decreased appetite, livedo
reticularis, insomnia, auditory hallucinations and orthostatic
hypotension.
About EASE LID and EASE LID
3The randomized, double-blind, placebo-controlled,
multi-center, ADS-5102 Phase 3 EASE LID and EASE LID 3 studies were
of identical design except for a longer treatment duration in EASE
LID. The two studies were designed to evaluate the safety and
efficacy of 340 mg amantadine HCl doses of ADS-5102 taken once
daily at bedtime -- for 25 weeks in EASE LID and 13 weeks in EASE
LID 3 -- for the treatment of LID in people with Parkinson's
disease. The primary efficacy endpoint for both studies was the
change from baseline in the UDysRS total score at Week 12, which
assessed the reduction in LID. Key secondary efficacy endpoints
were changes from baseline in ON time without troublesome
dyskinesia, OFF time, and ON time with troublesome dyskinesia at
Week 12 (and Week 24 in EASE LID), as assessed by a standardized
Parkinson’s disease home diary.
In accordance with the nomenclature naming
guidance of the U.S. Pharmacopeia salt policy, potential labeling
of ADS-5102 for the treatment of LID in people with Parkinson’s
disease will refer to 274 mg amantadine (equivalent to 340 mg
amantadine HCl) capsules, as the recommended daily dose. For
reference, the equivalent quantity of amantadine contained in a 100
mg amantadine HCl immediate release tablets is 80.6 mg.
About ADS-5102 ADS-5102 is a
high-dose amantadine, taken once daily at bedtime, in development
for the treatment of levodopa-induced dyskinesia (LID) in people
with Parkinson's disease. A New Drug Application (NDA) supporting
ADS-5102 for the treatment of LID in people with Parkinson's
disease is under review by the U.S. Food and Drug Administration
(FDA), with a Prescription Drug User Fee Act (PDUFA) date of August
24, 2017. If approved, ADS-5102 will be the first and only
FDA-approved medicine indicated for the treatment of LID in people
with Parkinson's disease. Adamas is also investigating ADS-5102 for
the treatment of walking impairment in people with multiple
sclerosis and is considering developing it for other indications
earlier in the Parkinson's disease treatment journey.
About Parkinson's Disease and
Levodopa-induced Dyskinesia Parkinson's disease is a
chronic neurodegenerative disorder affecting close to 1 million
people in the United States. It is characterized by the progressive
loss of dopaminergic neurons, causing lower levels of endogenous
dopamine and manifesting as symptoms of bradykinesia (slowness of
movement), rigidity, impaired walking, tremor and postural
instability.
Levodopa, which replaces lost dopamine, is the
most effective therapy for all stages of Parkinson's disease and is
considered the "gold standard" therapy. Over time, people require
increasingly higher or more frequent doses of levodopa in order to
avoid the recurrent periods of OFF time when the underlying
symptoms of Parkinson’s disease return. As Parkinson’s disease
progresses, nearly all people on levodopa therapy will also
experience LID, which is characterized by involuntary movements
that are non-rhythmic, purposeless and unpredictable. These people
often experience multiple fluctuating periods of OFF time and LID
during any given day, which can impede their movement and daily
function. In the United States, approximately 150,000 to 200,000
people with Parkinson’s suffer from LID.
About Adamas Pharmaceuticals,
Inc.Adamas develops 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 people with
Parkinson's disease and walking impairment in people with multiple
sclerosis. An NDA supporting ADS-5102 for the treatment of LID in
people 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,
are currently marketed by Allergan under the brand names NAMENDA
XR® and NAMZARIC®, 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 of ADS-5102 for the treatment of
levodopa-induced dyskinesia in people with Parkinson's disease and
the potential clinical benefits of ADS-5102. Words such as
"expect," "anticipate," 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 Adamas' research, clinical, development and commercial
activities relating to ADS-5102 and ADS-4101, the regulatory and
competitive environment and Adamas' business in general, see
Adamas' Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 28, 2017. 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.
Contact:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
Email: ir@adamaspharma.com
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