Cynapsus Therapeutics (NASDAQ:CYNA; TSX:CTH) has enrolled the first patient in the CTH-301 clinical trial, a pivotal Phase 3 study to examine the safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson’s disease (PD).
CTH-300, a pivotal Phase 3 efficacy study, is also ongoing with data expected from both trials in 2016.
In a statement, CMO, Dr. Albert Agro said the CTH-301 study, together with the CTH-300 efficacy study, would form the basis for an expected NDA submission near the end of 2016.
“We believe that apomorphine, the only approved drug to rapidly treat OFF episodes, combined with our sublingual film delivery technology, could provide many patients with a rapid, reliable means of turning ON from the OFF state,” he added.
The primary endpoint for the six-month study is the safety and tolerability of APL-130277 in patients with PD. The secondary endpoints examine efficacy variables, including the change in the MDS-UPDRS Part III scores over the six months of treatment.
Sites will recruit patients over several months, with each patient being evaluated for six months. An estimated 226 patients will be enrolled, including up to 126 who had been enrolled in the CTH-300 efficacy study and rolled over to the 301 study, plus an additional 100 new patients.
“We believe that APL-130277 can, if approved, change the way a large number of patients around the world manage OFF episodes,” said Anthony Giovinazzo, president and CEO.
“While we expect to have 12 weeks of safety data from the CTH-300 efficacy study in early-to mid-2016, the six-month data from the CTH-301 safety study will provide a much more robust assessment of safety,” he added.
