- Results suggests APL-130277 rapidly and effectively converts patients from the OFF to full ON state -
- Manuscript published online ahead of print -

TORONTO, Aug. 12, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that data from its CTH-105 Phase 2 trial of APL-130277 for the treatment of OFF episodes in patients with Parkinson’s disease was published in the peer-reviewed journal Movement Disorders. The paper, titled “Sublingual Apomorphine (APL-130277) for the Acute Conversion of OFF to ON in Parkinson’s Disease” by Robert A. Hauser, M.D., et al., was published electronically ahead of print. The company had previously announced top-line data from the CTH-105 trial in November of 2014.

Key findings from the manuscript include:

  • A full ON response was achieved by 15 of 19 patients dosed (78.9%) with a mean dose of 18.4 mg

  • All 15 responders (100.0%) achieved a full ON response within 30 minutes from the time of administration, and 6 of 15 (40.0%) achieved a full ON response within 15 minutes of administration

  • The mean duration of ON time was 50 (SD 19.4) minutes with 9 of 15 (60.0%) patients remaining fully ON for 90 minutes

  • A significant improvement in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS) from baseline was observed at all time points with a mean maximum change of 18.9 points

  • APL-130277 was safe and generally well-tolerated with no discontinuations because of adverse events

CTH-105 was a Phase 2 multicenter, open-label, clinical trial assessing APL-130277 in patients with Parkinson’s disease who experience OFF episodes, with a total duration of OFF of at least two hours daily. OFF episodes were achieved by having patients take their last dose of levodopa the night before coming into the clinic. Patients were not allowed to take their first dose of levodopa or other PD medications in the morning, resulting in a morning OFF state. Patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until ON was achieved, as documented by study staff, the patient and a clinician assessment of MDS-UPDRS. The MDS-UPDRS score was measured at 15, 30, 45, 60 and 90 minutes.

Albert Agro, Ph.D., author and chief medical officer of Cynapsus, said “The Phase 2 results published in this manuscript confirm the preliminary findings announced in 2014 that APL-130277 was highly effective at rapidly and safely converting patients from OFF to full ON. We look forward to continued validation of our approach to treating patients suffering with OFF episodes with top-line data from our Phase 3 efficacy study expected late in the third quarter or early fourth quarter of this year. We also intend to share longer-term safety data and file our new drug application in the first half of 2017.”

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA in the first half of 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/ 

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; and beliefs related to potential benefits and effectiveness of and demand for the Company’s product candidate. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

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