TORONTO, April 15, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ: CYNA ) (TSX: CTH ), a specialty central nervous system (“CNS”) 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 Parkinson’s disease (“PD”), today announced that three clinical posters will be presented on Sunday, April 17, 2016 at the 68th American Academy of Neurology (AAN) Annual Meeting, in Vancouver, British Columbia, Canada.
The first of three presentations highlights efficacy data from Cynapsus’ CTH-105 Phase 2 trial utilizing a sublingual thin film of apomorphine, APL-130277, to treat OFF episodes in adult patients with PD. Results demonstrated patients’ mean time to full ON of 24 minutes and mean duration of ON of 50 minutes. In addition, there was a statistically significant and clinically meaningful improvement in motor function at all time-points as measured by Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS Part III). The second poster presentation discusses safety data from the same trial. The safety conclusions of this study indicated that APL-130277 was generally well-tolerated. Most adverse events (“AE”s) were mild to moderate in severity, there were no discontinuations due to an AE, and there was no apparent dose-response relationship with AEs observed. The third poster looks at the effects of sublingual apomorphine by disease severity on the acute management of OFF episodes in PD. Results from this study showed that APL-130277 rapidly converts PD patients of various disease severity from OFF to the full ON state. The posters will be accessible from Cynapsus’ corporate website at www.cynapsus.ca .
“The clinical data for APL-130277 in treating OFF episodes in Parkinson’s disease continue to be encouraging. The efficacy and safety data across a range of patients provide important insights on how our product candidate could be used to improve patient care,” said Albert Agro, Ph.D., Cynapsus’ chief medical officer. “Solid results from our Phase 2 study provide us confidence and optimism as we look forward to reporting clinical data from our Pivotal Phase 3 efficacy trial over the next several months. We anticipate that these data will be used to file our new drug application (“NDA”) near the end of 2016 or in early 2017.”
The following data will be presented Sunday, April 17, 2016 at AAN from 4:00-5:30 p.m. PDT.
Poster Presentations
- Safety of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson’s Disease (Poster #337) Presenter: Stuart Isaacson, M.D., Parkinson's and Movement Disorders Specialist, Boca Raton Regional Hospital, Director, Clinical Research Center, Parkinson’s Disease and Movement Disorders Center, Boca Raton, Florida
- The Effects of Sublingual Apomorphine (APL-130277) by Disease Severity on the Acute Management of OFF Episodes in Parkinson’s Disease (Poster #336) Presenter: Holly Shill, M.D., Neurologist, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, Director, Muhammad Ali Parkinson Center at Barrow Neurological Institute, Phoenix
- Efficacy of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson’s Disease (Poster #335) Presenter: Robert Hauser, M.D., M.B.A., Professor, Director College of Medicine - Neurology, Director, Parkinson’s Disease and Movement Disorders Center, University of Southern Florida, Tampa, Florida
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 near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca . For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here 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 near the end of 2016 or in early 2017; and expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies. 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-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 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.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.
Contact Information
Company Contact: Kristen Galfetti Vice President, Investor Relations (416) 703-2499 x246 kgalfetti@cynapsus.ca
Media Contact: Russo Partners LLC Matt Middleman (212) 845-4272 matt.middleman@russopartnersllc.com
