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Adamas Pharmaceuticals Initiates a Phase 2/3 Clinical Study of ADS-5102 for Parkinson's Disease


9/28/2011 5:57:32 AM

EMERYVILLE, Calif., Sept. 28, 2011/PRNewswire/ --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 EASED (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 EASED 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. "

EASED 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 EASED study steering committee remarked, "The EASED 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 www.EASEDPD.com, www.PDTrials.org and http://clinicaltrials.gov/ct2/show/NCT01397422.

About ADS-5102

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. For more information about Adamas, please visit www.adamaspharma.com.

SOURCE Adamas Pharmaceuticals, Inc.



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