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SOURCE Adamas Pharmaceuticals, Inc.
Positive Clinician-Reported Patient Assessments Consistent with Earlier Findings Reported with ADS-5102
EMERYVILLE, Calif., April 30, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a specialty pharmaceutical company, today presented data on the safety and efficacy of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a serious movement disorder associated with Parkinson's disease treatment. The data, from Adamas' Phase 2/3 EASED study, included assessments of patients receiving ADS-5102 using a metric called the Clinician's Global Impression of Change (CGI-C). The clinicians were asked to assess their impression of the change in a subject's clinical status related to overall Parkinson's disease, including LID. CGI-C is a tool to evaluate a patient's response over time and is routinely used for a number of diseases, including Parkinson's disease.
At the 340 mg dose level there was a statistically significant improvement in overall Parkinson's disease clinical status, including LID, versus placebo as measured by physicians using the CGI-C (p=0.0036).
"These clinician-reported data add to the totality of information we have generated on ADS-5102 and reflect the consistent improvements observed using a number of different outcome measures," said Natalie McClure, Ph.D., Adamas' Senior Vice President of Product Development. "The Phase 2/3 EASED study met its primary endpoint, and we have selected the dose for future development. We are now advancing ADS-5102 into a Phase 3 study, which is anticipated to start later this year."
Phase 2/3 Trial Design – EASED Study
The Phase 2/3 EASED trial was a randomized, double-blind, placebo-controlled, parallel-group study conducted at sites throughout the United States. Eighty-three Parkinson's disease patients with troublesome LID were randomized to placebo or one of three doses of ADS-5102 (260 mg, 340 mg, 420 mg), dosed once nightly for eight weeks. The primary outcome measure was the change from baseline to week eight in the Unified Dyskinesia Rating Scale (UDysRS) total score. Secondary outcome measures were: change from baseline in 24-hour patient diaries, the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Clinician's Global Impression of Change (CGI-C). The study met its primary endpoint demonstrating a statistically significant reduction in LID as measured by the change in UDysRS total score versus placebo. In addition, ADS-5102 was generally well tolerated and reported adverse events were consistent with Parkinson's disease and the known amantadine safety profile.
ADS-5102 is a controlled-release version of the approved drug amantadine. Adamas is developing ADS-5102 initially for treatment of LID, a movement disorder that frequently occurs in patients with Parkinson's disease after long-term treatment with levodopa, the most widely-used drug for Parkinson's disease. Many individuals with late-stage Parkinson's disease suffer from LID, and there are no approved treatments for this disorder. Patients with LID suffer from involuntary movements and reduced control over voluntary movements.
Adamas believes that ADS-5102 may address many of the limitations of immediate-release amantadine by allowing higher daily doses of amantadine to be administered once-nightly without a significant increase in side effects. In the EASED study, in patients taking ADS-5102, the amantadine plasma concentration achieved in the early morning through mid-day was approximately two-times that reached following administration of immediate-release amantadine, providing symptomatic relief to patients as they engaged in their daily activities. Further, the lower concentrations occurred in the evening, reducing the potential negative impact of amantadine's sleep-related side effects.
Phase 3 Study Planned
The upcoming Phase 3 study will be a multi-center, randomized, double-blind, placebo-controlled, two-arm parallel group trial. Its primary objective will be to confirm the efficacy of a once-nightly 340 mg dose of ADS-5102 for the treatment of LID in subjects with Parkinson's disease. The secondary objective will be to evaluate the safety and tolerability of ADS-5102 in the study population.
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. Adamas achieves this by enhancing the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing its lead wholly owned product candidate, ADS-5102, for a complication of Parkinson's disease known as levodopa-induced dyskinesia and as a treatment for chronic behavioral symptoms associated with traumatic brain injury.
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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements include, but are not limited to, statements regarding the timing of Adamas' second Phase 3 study for ADS-5102. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation: the accuracy of Adamas' estimates regarding its ability to initiate and/or complete its clinical trials; the success of Adamas' clinical trials and the demonstrated efficacy of Adamas' product candidates thereunder; regulatory developments in the United States and foreign countries; Adamas' ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Adamas' most recent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adamas undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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