Additional Relevant Details CTH-300 enrollment was completed on June 30, 2016 with 102 PD patients entering open-label DTP.   The DTP part of CTH-300 is now complete, with data available from the first 92 patients. Remaining patient data will be entered upon completion of their first post-randomization visit.Preliminary CTH-300 open-label DTP highlights include:

• The mean change in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) from baseline to 30 minutes was 22 points
• In 60% of patients, improvement in motor function was reported between 5 and 12 minutes after dosing.
• Improvement in motor function was maintained beyond 90 minutes with a mean improvement of the MDS UPDRS Part III of 16 points at that time point
•  83% of patients entering the open-label dose titration phase turned from OFF to fully ON
• 78% of patients entering the open-label dose titration phase turned fully ON within 30 minutes; approximately 38% were fully ON at 15 minutes
• The median dose of APL-130277 turning patients to fully ON was 20mg
• APL-130277 was well tolerated. During the dose titration period: 16% of patients reported nausea that was mostly mild in intensity; 8% of patients reported dizziness; 4% of patients reported somnolence; 2% of patients reported vomiting; and 1% of patients reported symptomatic hypotension
• There were no reports of local irritation during the open-label DTP of the CTH-300 study
• A total of 16 patients were dosed and did not complete the DTP of the study; five (5) of such patients discontinued due to an adverse event, nine (9) of such patients discontinued because the highest dose in this study was not sufficient to turn them from OFF to ON within 45 minutes and two (2) of such patients discontinued for administrative reasons.

“Top-line results from the DTP of CTH-300 corroborate our Phase 2 findings supporting the potential benefit of APL-130277 as an on-demand therapy for the management of OFF episodes in patients with Parkinson’s disease who suffer motor fluctuations,” said Dr. Albert Agro, Chief Medical Officer of Cynapsus. “The robustness of this preliminary clinical data, particularly the 22-point improvement in MDS-UPDRS Part III, gives us confidence that our sample size of 80 patients randomized, is more than sufficient to show statistical and clinical meaningful changes at 90% power in our primary and key secondary clinical endpoints.”