-- Poster presentations include clinical data on efficacy, safety
and disease severity --
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