Adamas Pharmaceuticals, Inc. 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."
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.