Adamas Pharmaceuticals Initiates A Phase 2/3 Clinical Study of ADS-5102 for Parkinson's
EMERYVILLE, CALIF., September 28, 2011 - Adamas Pharmaceuticals,
Inc., a privately held company, announced today that it has initiated a Phase 2/3
clinical trial of its proprietary investigational drug ADS-5102 (amantadine HCl
extended release) for the treatment of levodopa induced dyskinesia (LID) in patients
with Parkinson's disease. Called EASEDTM (Extended
Release Amantadine Safety and
Efficacy Study in Levodopa-Induced Dyskinesia),
this study will evaluate the safety and effectiveness of three dose levels of ADS-5102
in the treatment of LID.
"Commencement of this Phase 2/3 clinical study of ADS-5102 culminates years
of Adamas research into the use of amantadine as a treatment for LID in Parkinson's
disease, and represents the first well controlled, rigorously powered study of amantadine
aimed at licensure in this indication," said Gregory Went, Ph.D., Chief Executive
Officer of Adamas. "The EASEDTM study will build upon our
successful Phase 1 studies in healthy volunteers, which confirmed the desired target
pharmacokinetic profile and potential tolerability improvement associated with ADS-5102."
Dr. Matthew Stern, Professor of Neurology, University of Pennsylvania, a member
of Adamas' Clinical Advisory Board added, "LID represents a significant
unmet need in advanced Parkinson's disease. Unfortunately there is no drug approved
for this condition and patients face limited treatment options. We know that
amantadine has some utility in treating LID in Parkinson's disease - but a well
controlled, rigorously powered study of this drug has not been completed to date.
EASEDTM is a randomized, placebo controlled, clinical trial that will
enroll up to 80 Parkinson's disease patients at approximately 25 study sites
in the US. The study's primary endpoint is reduction in LID as assessed
by changes in the Unified Dyskinesia Rating Scale (UDysRS). Secondary endpoints
include assessment of "on time" without troublesome dyskinesia and reduction
in fatigue. The study is enrolling patients aged 30 to 80 who have Parkinson's
disease and who are experiencing troublesome LID. The protocol calls for study
participants to be randomized to receive a low, medium or high dose of ADS-5102
or placebo for eight weeks with a two week follow up. An Independent Data
Monitoring Committee will monitor the safety of participants throughout the duration
of the study. Adamas expects the study to be completed in 2012.
Dr. Rajesh Pahwa, MD, Professor of Neurology, Kansas University Medical Center,
a member of the EASEDTM study steering committee remarked, "The
EASEDTM study is designed to evaluate a novel formulation of amantadine
and to establish a dose response in treating LID. At the conclusion of this
study, we will have a much better picture of the benefits of ADS-5102 in the treatment
of LID, as well as its impact on additional motor and non-motor symptoms that affect
the quality of life of patients with Parkinson's disease. Of additional importance,
if this study is successful, we will confirm our ability to reliably study LID and
pave the way for future innovations."
Parkinson's disease patients can potentially gain access
to this study through the Fox Trial Finder of the Michael J. Fox Foundation at https://foxtrialfinder.michaeljfox.org/trial/2541.
In addition, information on the study can be found at http://www.easedpd.com/,
http://www.pdtrials.org/ and http://clinicaltrials.gov/ct2/show/NCT01397422.
ADS-5102 is a proprietary formulation of amantadine in development for the treatment
of levodopa induced dyskinesia (LID) in patients with Parkinson's disease. ADS-5102
has a pharmacokinetic profile designed to overcome the dose limiting side effects
associated with immediate release forms of amantadine, while offering potential
for enhanced efficacy. The novel pharmacokinetic profile of ADS-5102 is characterized
by higher plasma concentrations during the daytime hours when the dyskinesia as
well as the motor and non-motor symptoms of the disease are at their peak, and low
plasma concentrations overnight, which may reduce sleep disturbance and vivid dreams
occasionally associated with amantadine. In addition, ADS-5102 exhibits a
reduced initial rate of rise in plasma concentration, which is expected to improve
overall CNS tolerability of amantadine.
About Levodopa-Induced Dyskinesia
Levodopa remains the gold standard for the treatment of the debilitating motor symptoms
of Parkinson's disease. However the utility of levodopa therapy is limited by
levodopa-induced dyskinesia (LID), a troublesome condition that over time afflicts
nearly all patients who take levodopa. Patients with early onset Parkinson's
disease seem to be particularly likely to develop troublesome LID. About 200,000
Parkinson's disease patients in the US are estimated to be suffering from LID
of moderate to severe intensity. Reducing or eliminating LID and improving
on-time without troublesome dyskinesia are among the greatest needs in the treatment
of advanced Parkinson's disease.
About Adamas Pharmaceuticals
Adamas is a clinical stage pharmaceutical company developing novel formulations
and combinations of aminoadamantanes designed for superior efficacy, tolerability,
and compliance. Adamas' has three (3) programs in mid-to-late stage clinical
development including ADS-5102 for the treatment of levodopa-induced dyskinesia
(LID) in Parkinson's disease, ADS-8704 for the treatment of dementia, and ADS-8902,
triple combination antiviral drug therapy (TCAD) for the treatment of serious
or complicated influenza. Adamas is headquartered in Emeryville, California,
with operations in Bangalore, India.