TORONTO, June 30, 2016 (GLOBE
NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a
specialty central nervous system (CNS) pharmaceutical company
developing and preparing to commercialize APL-130277, a
fast-acting, easy-to-use, sublingual thin film for the on-demand
management of debilitating OFF episodes associated with Parkinson's
disease (PD), announced today that the last patient has been
enrolled in its pivotal Phase 3 efficacy study, CTH-300. Dose
titration phase results from this study are expected in mid to late
July and top-line data are expected to be released near the end of
the third quarter of 2016.
The CTH-300 trial is a double-blind,
placebo-controlled, parallel-design study with PD patients who have
at least one OFF episode every 24 hours, with total OFF time of at
least two hours per day. The study objective is to evaluate the
efficacy and safety of APL-130277 versus placebo in patients with
PD. Patients will each be observed for 12 weeks, with dosing at
home and in clinic. The primary endpoint is mean change in the
Movement Disorder Society's Unified Parkinson's Disease Rating
Scale Part III score at 30 minutes after dosing in the clinic at
week 12. The key secondary endpoint will be the percentage of
patients who convert from the OFF to the ON state at or before 30
minutes of dosing with APL-130277 at the week 12 visit.
About
Parkinson's Disease and OFF Episodes
More than 1 million people in the
U.S. and an estimated 4 to 6 million people worldwide suffer from
Parkinson's disease. Parkinson's disease is a chronic,
progressive neurodegenerative disease that impacts motor activity,
and its prevalence is increasing with the aging of the
population. OFF episodes are a complication of Parkinson's
disease characterized by motor symptoms, including tremor at rest,
rigidity and impaired movement, as well as significant non-motor
symptoms such as cognitive impairment and mood disorders. An
estimated one quarter to one half of all people with Parkinson's
disease whose symptoms are otherwise managed with ongoing drug
therapy experience OFF episodes at least once daily and up to six
times daily, with each episode lasting between 30 and 120
minutes.
About
Cynapsus
Cynapsus is a specialty 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 PD. The
Company 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' Phase 3 clinical program for APL-130277 plans
to rely 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 please visit the
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 anticipated
timing, completion and results of Phase 3 and other clinical
studies; the Company's expectation for filing an NDA near the end
of 2016 or in early 2017; and beliefs related to potential benefits
and effectiveness of Cynapsus' 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-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.