Cynapsus Therapeutics Inc. on Wednesday announced enrollment of the first patient in the CTH-301 clinical trial.
CTH-301 is a pivotal Phase 3 study examining the safety and tolerability of APL-130277 for the acute treatment of off episodes in patients with Parkinson's disease.
"Approximately 400,000 people with (Parkinson's disease) in the U.S. experience debilitating OFF episodes,” Cynapsus CEO and President Anthony Giovinazzo said. “When (Parkinson's disease) patients experience an off episode, they are often unable to perform simple daily tasks such as eating, bathing and dressing, thus becoming increasingly dependent on caregivers. We believe that APL-130277 can, if approved, change the way a large number of patients around the world manage off episodes.
"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."
CTH-300, a pivotal Phase 3 efficacy study, is also continuing. Data is expected from both trials in 2016.
"Enrolling the first patient in the CTH-301 safety study is a significant milestone for Cynapsus,” Albert Agro, chief medical officer of Cynapsus, said. “The design and endpoints for this study were based on an end-of-Phase 2 meeting with the (Food and Drug Administration) earlier this year. The CTH-301 study, together with the CTH-300 efficacy study, will form the basis for our expected (new drug application) submission near the end of 2016.”