TORONTO, May 30, 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 today
at the 2nd Congress of the European Academy of Neurology (EAN)
Annual Meeting, in Copenhagen.
The following data will be
presented by Eric J. Pappert, M.D., Vice President Global Medical
Affairs, Cynapsus Therapeutics, today from 12:30-13:15 p.m.
CET.
Poster Presentations
- Apomorphine Film (APL-130277)
Produces No Buccal Mucosal Irritation: Results from a 28-Day
Toxicology Study in Hamsters (Poster #31123)
- 28-day toxicology study in 16
hamsters
- APL-130277, Cynapsus' apomorphine
film, produced no irritation of the cheek pouch buccal mucosal of
male and female hamsters when administered at a dose of 2.08 mg (15
times higher than a 30 mg dose in a 60 kg human) three times daily
for 28 consecutive days
- Treatments of OFF Episodes in
Parkinson's Disease: An Evaluation of Physician Practices (Poster
#31122)
- Responses from 120 caregivers and
patients on the impact of OFF episodes on quality of life (QoL) and
satisfaction with current patient treatment
- 32.6% of patients and caregivers
indicated that they had OFF episodes in the first year post
diagnosis
- 53.3% of patients and caregivers
indicating that OFF episodes started 2-3 years post diagnosis
- Patients and caregivers reported
that OFF episodes had a negative impact on QoL
- The Treatment of OFF Episodes in
Parkinson's Disease: An Evaluation of Patient and Caregiver
Insights (Poster #31121)
- 102 physicians who treat patients
with PD were queried on their practices and attitudes regarding the
treatment of OFF episodes
- Physicians are concerned about OFF
episodes and feel that their patients are aware of OFF
episodes
- Physicians feel that there is a
fairly high level of unmet need regarding treatment options for OFF
episodes
The posters will be accessible from Cynapsus'
corporate website at www.cynapsus.ca.
"We are pleased to share data demonstrating that
the APL-130277 sublingual thin film produced no signs of mucosal
irritation in hamsters at doses significantly higher than the
highest dose planned for patients," said Albert Agro, Ph.D., chief
medical officer of Cynapsus. "These data, in addition to prior
positive results shared at medical meetings, provide evidence of
the potential safety of APL-130277 in treating OFF episodes. In
addition, information gathered through extensive surveys we
conducted supports our beliefs that physicians are concerned about
OFF episodes and that there exists a high unmet need. Most
importantly, survey results showed patients are open to new
treatments that would result in an improved quality-of-life.
We look forward to sharing clinical data from our pivotal Phase 3
efficacy trial over the next several months and anticipate using
these data to file our new drug application (NDA) near the end of
2016 or in early 2017."
Cynapsus also hosted a satellite symposium at EAN.
Additional information can be found below and at the website
link:https://www.eaneurology.org.
Cynapsus Sponsored
Symposium
From OFF to ON - New approaches to the treatment
of OFF episodes in Parkinson's Disease
The symposium was held on Saturday, May 28, 2016,
and included discussions on Levodopa-induced OFF episodes,
approaches to the treatment of OFF episodes and rescue therapies.
Participants included C. Warren Olanow, Fabrizio Stocchi and
Anthony H.V. Scharpira.
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 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; expectations
regarding the Company's clinical and regulatory activities,
including without limitation, the anticipated timing and completion
of clinical studies; and beliefs related to potential demand for
our 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.