News 
Market Data 
Discover
Replies to post #494 on Cynapsus Therapeutics Inc. (CYNA)
To date, Cynapsus has studied approximately 110 subjects / patients in five clinical studies, with the most recent result being our CTH-105 Phase 2 clinical trial, which had 16 people with Parkinson's disease who completed the dosing regimen. Out of 16 patients, 14 converted from OFF to ON with clinically meaningful improvement in motor control in as early as 10 minutes after administration of APL-130277 and lasted longer than 90 minutes. The maximum mean change from baseline UPDRS III was 18.4, which is a large clinically important difference. The CTH-105 Phase 2 clinical trial results showed the APL-130277 treatment was safe and well-tolerated, with no local irritation, no postural hypotension and a low number of nausea events.
Cynapsus expects to initiate Phase 3 clinical trials in 2015, which will be of longer duration and with larger patient numbers to confirm the efficacy and safety of APL-130277. The details of these trials will form the basis for the registration package necessary for a 505(b)(2) New Drug Application, or NDA, with the United States Food and Drug Administration, or the FDA, expected to be submitted to the FDA in 2016.
• Nineteen products in development or approved have an impact on OFF episodes.
• Three approved and two products in development are likely directly competitive with APL-130277.
• APL-130277 may be better able to meet patient needs than the three approved competitive products and the two competitive products in development.
• APL-130277 may have a higher probability of regulatory success than the two competitive products in development.
The report concluded that APL-130277 had safety, convenience and efficacy advantages over competitive products on the market and in development.
The results of this research further confirm the Corporation’s identification of unmet medical need and market opportunity for APL-130277.
AI
