Sublingual Apomorphine successful with treating off episodes
 

Cynapsus Therapeutics' APL-130277 Improved Parkinson's Symptoms and Rapidly Turned Patients from OFF to ON

Data Presented at the International Congress of Parkinson's Disease and Movement Disorders APL-130277, Sublingual Apomorphine, for On-Demand Treatment of OFF Episodes Associated with Parkinson's Disease
TORONTO, ONTARIO--(Marketwired - Jun 25, 2015) - Cynapsus Therapeutics Inc. (CYNA)(CTH.TO) (the "Company") today announced that it presented data from clinical trials of APL-130277, a sublingual apomorphine thin film under development for the on-demand treatment of OFF episodes associated with Parkinson's disease (PD). Data from the Company's CTH-105, CTH-104 and CTH-103 clinical studies, presented at the 19th International Congress of Parkinson's Disease and Movement Disorders (MDS) in San Diego, California, showed APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), rapidly turned patients from the OFF to ON state and was generally safe and well tolerated.

"Phase 1 and Phase 2 data presented at the Congress demonstrated that APL-130277 can achieve the appropriate apomorphine plasma levels needed to rapidly and reliably convert a patient from the OFF to the ON state. In addition, APL-130277 was safe and effective for the acute treatment of OFF episodes in PD patients," said Jordan Dubow, M.D., Vice President, Medical Affairs, Cynapsus Therapeutics. "These data lead in to our Phase 3 pivotal studies to assess the efficacy, safety and tolerability of APL-130277 for the acute, on-demand management of OFF episodes."

Presentations at MDS included:

Efficacy of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson's disease; Hauser et al.
CTH-105 was a Phase 2 open-label multicenter study in which APL-130277 was assessed in 19 patients with PD who experienced OFF episodes, with a total duration of at least two hours of OFF episodes daily.
Of the 19 total patients dosed, 15 achieved a full ON response. Of the four non-responders, two were dosed incorrectly and two were dosed up to the maximum available dose (30mg).
Sublingually administered APL-130277 rapidly converted PD patients from the morning OFF state to the full ON state with 100% of responders turning fully ON within 30 minutes and 40% within 15 minutes.
APL-130277 provided, rapid, clinically meaningful and statistically significant improvement in motor function as assessed by MDS-UPDRS Part III score at all time points assessed (i.e. 15, 30, 45, 60 and 90 minutes) with a mean maximal improvement of 18.9 points in the intent to treat population.
Thirteen of the 15 patients that turned ON remained ON for at least 30 minutes, nine of whom remained ON for at least 60 minutes, with a mean duration of ON of over 50 minutes.
The percentage change in MDS-UPDRS Part III was approximately 30% or greater at all time points measured, with a maximum mean percentage change at any time point of 45.6% for the intent to treat population. Mean percentage change of approximately 30% is generally considered a clinically meaningful level at which point patients turn ON.

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