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Adamas Announces Positive Top-line Results from its Phase 3 EASE LID 3 Trial of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) in Patients with Parkinson’s Disease

Third Randomized Clinical Trial Meets Primary and Key Secondary Endpoints

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EMERYVILLE, Calif., April 28, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (ADMS) today announced that its Phase 3 trial (EASE LID 3) evaluating ADS-5102 (amantadine HCl) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease (PD) met its primary and key secondary endpoints. Results from this randomized, double-blind, placebo-controlled study showed a statistically significant improvement (p<0.0001) in LID at 12 weeks (primary endpoint) for patients who received ADS-5102 versus placebo as assessed by the Unified Dyskinesia Rating Scale (UDysRS). Additionally, a statistically significant increase in ON time without troublesome LID (p=0.0168) and a statistically significant decrease in OFF time (p=0.0199) versus placebo, both key secondary endpoints, were observed. The company plans to present the data at an upcoming scientific conference.

“We are thrilled by the data resulting from EASE LID 3, our third randomized clinical study of ADS-5102 to have met its primary endpoint and show a statistically significant improvement in LID,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We are pleased to see data from all three studies in LID that suggest ADS-5102 is the first investigational therapy with the potential to positively affect both dyskinesia and OFF time. We are excited about the possible role ADS-5102 may have in helping people with Parkinson’s disease, and we look forward to submitting a new drug application (NDA) to the FDA this year.”

“The uncontrollable involuntary movements associated with LID can be disruptive and debilitating for those living with Parkinson’s disease,” stated Joseph Jankovic, M.D., Professor of Neurology, Distinguished Chair in Movement Disorders and Director of the Parkinson Disease Center and Movement Disorders Clinic at the Baylor College of Medicine in Houston, Texas. “It is very encouraging to see that ADS-5102 has shown a reduction in LID across three clinical studies as well as a decrease in OFF time in two clinical studies.”

In the EASE LID 3 study, 77 PD patients with LID were randomized to placebo or active treatment (340 mg ADS-5102). Efficacy analyses were based on a modified intent-to-treat population of 75 patients. The treatment groups were similar with respect to baseline demographics and PD-related medical history. Data are summarized below:

Primary Endpoint (UDysRS)

  • The percent reduction from the observed mean UDysRS total score at baseline compared to that at week 12 was 50 percent in the ADS-5102 group and 18 percent in the placebo group. The least square (LS) mean treatment difference at week 12 was statistically significant (p<0.0001, primary endpoint).

Secondary Endpoints
PD Home Diaries

  • ON time without troublesome dyskinesia increased by 4.0 hours per day in the ADS-5102 group and 2.1 hours per day in the placebo group (p=0.0168, key secondary endpoint).
  • OFF time decreased by 0.5 hours per day in the ADS-5102 group and increased by 0.6 hours per day in the placebo group (p=0.0199, key secondary endpoint).
  • ON time with troublesome dyskinesia decreased by 3.6 hours per day in the ADS-5102 group and 2.5 hours per day in the placebo group (p=0.0853).

Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)

  • A statistically significant reduction (p<0.0001) in the MDS-UPDRS (Part IV) score was seen in the ADS-5102...

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