Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that its
Phase 3 EASE LID clinical trial evaluating the company’s
investigational compound ADS-5102 (amantadine HCl) extended-release
capsules for the treatment of levodopa-induced dyskinesia (LID)
associated with Parkinson’s disease met its primary endpoint.
Results from this randomized, placebo-controlled study showed a
statistically significant reduction (p = 0.0009) in LID at 12 weeks
for patients who received ADS-5102 versus placebo as assessed by
the Unified Dyskinesia Rating Scale (UDysRS). This represents
a 23 percent reduction in LID for ADS-5102-treated patients
compared to placebo. The reduction in LID was maintained at
24 weeks (p = 0.0008), a key secondary analysis. The company
plans to present comprehensive data at an upcoming scientific
conference.
“We are very pleased with these top-line results that confirm
and extend the positive findings from our earlier randomized,
placebo-controlled study,” stated Gregory T. Went, Ph.D., Chairman
and Chief Executive Officer of Adamas Pharmaceuticals, Inc.
“Parkinson’s disease patients have no approved medicine for this
potentially serious complication of levodopa therapy. With
these data in hand, we look forward to talking with the FDA about
our planned NDA submission for ADS-5102."
In this study, there were four additional key secondary analyses
based on patient diary data. All achieved statistical
significance. Notably, at week 12, ADS-5102 significantly
increased ON time without troublesome dyskinesia by 2.7 hours
versus placebo and reduced OFF time by 0.9 hours. These
effects were maintained at week 24.
“These data are impressive and suggest that ADS-5102 has a
clinically relevant effect on dyskinesia,” said Rajesh Pahwa,
M.D., Laverne & Joyce Rider Professor of Neurology, Director of
the Parkinson’s Disease and Movement Disorder Center at the Kansas
University Medical Center. “As a member of the Parkinson’s
community, I welcome a drug for treating levodopa-induced
dyskinesia that does not worsen the motor features of Parkinson’s
disease.”
Efficacy analyses were based on a modified intent to treat
(mITT) population of 121 moderate to advanced Parkinson’s disease
patients with LID. The treatment groups were similar with
respect to baseline demographics and Parkinson’s disease related
medical history.
The reported adverse events associated with ADS-5102 were
consistent with the known safety profile of amantadine as well as
the safety results from our earlier placebo-controlled trial.
The most common adverse events (occurring in greater than
five percent of ADS-5102-treated patients) were: hallucinations,
peripheral edema, dizziness, dry mouth, constipation, falls,
urinary tract infections, anxiety, contusion, livedo reticularis,
abnormal dreams, depression and headaches. Four subjects
discontinued treatment due to adverse events in the placebo group
versus 13 in the ADS-5102 group. There were 17 severe adverse
events, four in the placebo group and 13 in the ADS-5102
group. Of these severe adverse events, one event in the
placebo group and three events in the ADS-5102 group were assessed
to be study drug related. There were 10 serious adverse
events, three in the placebo group and seven in the ADS-5102 group,
none of which were assessed to be study drug related.
About EASE LIDThe Phase 3 EASE LID study was a
multi-center, randomized, double-blind, placebo-controlled study
designed to evaluate the safety and efficacy of 340 mg of ADS-5102
dosed once daily at bedtime for 24 weeks in patients with LID
associated with Parkinson’s disease. The study's primary
efficacy analysis measured the reduction in LID over 12 weeks as
assessed by the Unified Dyskinesia Rating Scale (UDysRS). The
key secondary efficacy outcome measures were a reduction in LID
over 24 weeks as assessed by the UDysRS and changes in a
standardized Parkinson’s disease diary, including ON time without
troublesome dyskinesia and OFF time at weeks 12 and 24.
Additional secondary efficacy outcome measures included overall
Parkinson’s disease clinical status as assessed by the MDS-Unified
Parkinson's Disease Rating Scale (MDS-UPDRS) and the Clinicians
Global Impression of Change.
Conference Call and Webcast Today, December 23, at 8:00
a.m. Eastern Time (5:00 a.m. Pacific Time)The Adamas
management team will host a conference call and webcast at 8:00
a.m. ET/ 5:00 a.m. PT on Wednesday, December 23 to discuss the
study results. Interested parties may access the webcast on
the Adamas website at http://ir.adamaspharma.com/events.cfm, or by
dialing 844-215-3280 (domestic) or 484-747-6383 (international) and
referencing conference ID 15542042. A replay of the call will be
available on the Adamas website later in the day. The replay
will be available for approximately one month following the
call.
Ongoing Phase 3 StudiesIn addition to the EASE
LID study discussed in this release, the company is conducting EASE
LID 3, a Phase 3, 13-week, multi-center, randomized, double-blind,
placebo-controlled study designed to assess 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 UDysRS from baseline to week 12. The
trial completed enrollment of 77 patients in December 2015.
Adamas is also conducting EASE LID 2, an open-label safety study,
which is open to patients from EASED, EASE LID, EASE LID 3 and 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 (LID), a condition characterized by
involuntary movements without purpose. 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.
About Adamas PharmaceuticalsAdamas
Pharmaceuticals, Inc. is 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
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 and other symptoms of
Parkinson’s disease, regulatory progress and interactions with the
FDA. 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 the FDA’s
interpretation and review of the ADS-5102 data and program, and
ongoing research, clinical and development activities of ADS-5102,
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 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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