Adamas Pharmaceuticals, Inc. presented positive results today from the Phase 2/3 EASED™ clinical trial of ADS-5102 at the World Parkinson's Congress. ADS-5102 is Adamas' proprietary long-acting capsule formulation of amantadine HCl in development for the treatment of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) patients. ADS-5102 met its primary endpoint in the Phase 2/3 clinical trial and demonstrated statistically significant improvements in a number of key assessments of LID.
"We are extremely pleased with the positive results achieved in our Phase 2/3 EASED trial, and the magnitude of the change in ON time without troublesome dyskinesia in Parkinson's patients suffering from LID. Levodopa-induced dyskinesia is one of the most difficult challenges facing patients with PD, and there are no FDA-approved drug treatments available," said Gregory T. Went, Ph.D., Chief Executive Officer of Adamas. "ADS-5102 reduced both the duration and severity of dyskinesia among PD patients with statistical significance, providing an average of 11.5 hours during the day of ON time without troublesome dyskinesias as compared to 8 hours on placebo. The encouraging data from this trial indicate that ADS-5102 has the potential to positively impact the lives of PD patients and we are moving forward on the remaining NDA-enabling activities."
The Phase 2/3 EASED clinical trial was designed to investigate the safety and efficacy of three dose levels of ADS-5102 administered once nightly at bedtime for the treatment of LID in PD. The study enrolled 83 subjects who were randomized in a 1:1:1:1 ratio to the four treatment groups: placebo, 260 mg ADS-5102, 340 mg ADS-5102 and 420 mg ADS-5102. Both the 340 mg and 420 mg ADS-5102 dose levels significantly reduced LID as measured by the change in Unified Dyskinesia Rating Scale (UDysRS) total score over eight weeks versus placebo, meeting the primary endpoint for the clinical study. Of note, the reduction in LID was seen at two weeks following the first dose of study medication. At week 8, the ON time without troublesome dyskinesia as measured by patient diaries was 11.0 hours, 11.5 hours, and 12.1 hours for the 260 mg, 340 mg, and 420 mg dose levels, respectively, compared to 8.0 hours for placebo. These findings were statistically significant, demonstrating an increase of about 3 hours over placebo compared to baseline values. ADS-5102 also demonstrated statistically significant functional improvement in dyskinesia as assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV, a measure of the degree of impact that dyskinesia has on the patient's daily function in terms of activities and social interactions.
Treatment with ADS-5102 did not result in worsening of PD, as measured by the MDS-UPDRS combined score (Parts I, II and III). The adverse events reported in this study were typically mild to moderate in severity and consistent with Parkinson's disease and the known amantadine safety profile. There was no difference from placebo in the incidence of sleep-related adverse events.
Data from the Phase 2/3 study were presented today in a poster entitled "Safety and Efficacy of ADS-5102 in Levodopa-Induced Dyskinesia (EASED Study)" (Abstract #1311.00) at 11:30 am ET at the World Parkinson's Congress in Montreal, Canada. The poster has also been selected for a "Guided Poster Tour" between 5:15-6:45 pm ET.
Adamas Pharmaceuticals, Inc.