Marketwire, January 10, 2012
- Sublingual Thin Film Strips of Apomorphine are for
the Treatment of Motor Fluctuations in Advanced
Parkinson's Disease.
- A confirmatory Phase 1 Bioequivalence Study followed
by a Safety Study, are expected to lead to a New Drug
Application by late 2013 or early 2014.
TORONTO, CANADA - (Marketwire) - Cynapsus Therapeutics Inc.
(CTH: TSX-V), a specialty pharmaceutical company, today
announced positive headline data from its recently
completed human volunteer pilot proof-of-concept trial for
APL 130277, a sublingual thin film strip formulation of
apomorphine. The study showed a pharmacokinetic (PK)
profile that compared favorably to injected apomorphine
with a mean T-max of 25 minutes and good tolerability, and
therefore confirms that APL-130277 has the potential to
treat motor fluctuations or "off episodes" in
Parkinson's disease.
"The successful completion of this first in man study is an
important derisking event for APL-130277 and sets the stage
for completing the clinical requirements over the next two
years to qualify for an accelerated New Drug Application.
This significant achievement, combined with the recent
announcement of our 500 neurologist survey (December 8,
2011) that confirmed a potentially expanded market for this
acute rescue treatment of the debilitating daily freezing
episodes, sets a firm foundation of credibility and
potential value," said Anthony Giovinazzo, President and
CEO of Cynapsus.
Dr. Albert Agro, Chief Medical Officer at Cynapsus,
commented: "We are encouraged by the safety and
pharmacokinetic results obtained in this pilot study. The
results confirm our hypothesis that a sublingual thin-film
strip delivery of apomorphine is safe, well-tolerated and
produces a rapid absorption profile that, after dose
adjustment, mirrors that of a subcutaneous injection of
apomorphine. Most importantly, the T-max of less than 25
minutes confirms that the sublingual delivery system is
well equipped to provide therapeutic benefit to patients
suffering from Parkinson's disease who have 'off episodes'.
Planning is now underway for the final configuration of the
film strip system, for the full bioequivalence study, and a
subsequent safety study in patients, with Parkinson's
disease as vetted by the FDA."
The pharmacokinetics and safety/tolerability of sublingual
APL-130277 formulation (3 mg dose) were demonstrated in a
Phase I pilot study in 15 healthy volunteers with 12 of 15
subjects receiving drug product and 3 of 15 receiving
placebo. Following washout, patients were dosed in a second
period with APL-130277 placing the drug in a different
orientation under the tongue. The study determined that the
sublingual orientation does impact the T-max and PK of
APL-130277. In the majority of subjects, maximum blood
levels were reached within 20 minutes of administration. A
detailed analysis of the data is expected to be available
within the next 30 days. Other pharmacokinetic parameters
mirrored those seen with a subcutaneous injection of
apomorphine after an expected dose adjustment.
APL-130277 product showed good tolerability. APL-130277 was
safe and well-tolerated. Adverse events were mild in
intensity with one subject having moderate nausea and
dizziness post dosing. In placebo treated subjects, 33% had
at least one adverse event during the treatment period,
with 17% of subjects having at least one adverse event in
the APL-130277 treatment group. The systemic adverse
effects were typical of adverse effects that are commonly
observed with apomorphine injection.
Apomorphine, a potent dopamine agonist, is currently the
only drug approved specifically for the treatment of acute
motor fluctuations/hypomobility (freezing or
"off" episodes) in patients with advanced
Parkinson's disease. Presently, apomorphine is
administered by intermittent sc injection usually via a
pre-filled injection pen, or by continuous (waking day or
round the clock) infusion pump outside the US. Drawbacks
associated with subcutaneous injection therapy for patients
and care givers include the need for multiple injections,
which can be painful and are often associated with the
development of nodules at the injection site, and the
requirement for a degree of manual dexterity that some PD
patients find difficult.
APL-130277 is a solid dosage form of apomorphine
hydrochloride that dissolves rapidly under the tongue
(typically, 1-2min), is absorbed directly into the blood
stream from the mouth and reproduces the blood levels
typically obtained by injection. APL-130277 allows for easy
self-administration without the injection site side
effects. The results of this Phase 1 pilot study are
consistent with the use of APl-130277 as an acute rescue
treatment of hypomobility in advanced PD and illustrate the
product's potential to replace apomorphine injections.
Cynapsus is a specialty pharmaceutical company developing
an improved dosing formulation of an approved drug used to
treat the symptoms of Parkinson's disease. Parkinson's
disease is a chronic and progressive neurodegenerative
disease that impacts motor activity, and its prevalence is
increasing with the aging of the population. It is
estimated that between 25 percent and 50 percent of
patients experience "off episodes" in which they have
impaired movement or speaking capabilities. Current
medications only control the disease's symptoms, and most
drugs become less effective over time as the disease
progresses.
Cynapsus' lead drug candidate, APL-130277, is an
easy-to-administer, fast-acting and oral reformulation of
an approved drug, apomorphine, used to rescue patients from
off episodes. Cynapsus is focused on rapidly maximizing the
value of APL-130277 by completing pivotal studies in
advance of a New Drug Application expected to be submitted
in 2013 or 2014. Cynapsus anticipates out-licensing to an
appropriate pharmaceutical partner before such an
application is submitted.
More information about Cynapsus (CTH: TSX-V) is available
at www.cynapsus.ca and at the System for Electronic
Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca
Andrew Williams
COO & CFO
(416) 703-2449 x253
awilliams@cynapsus.ca
Media contacts:
Russo Partners LLC
Ian Stone
(619) 528-2220
Ian.Stone@russopartnersllc.com
Robert E. Flamm, Ph.D.
(212)-845-4226
Robert.flamm@russopartnersllc.com
This press release contains "forward-looking
statements" within the meaning of applicable Canadian
securities legislation. Generally, these forward-looking
statements can be identified by the use of forward-looking
terminology such as "plans", "expects"
or "does not expect", "is expected",
"budget", "scheduled",
"estimates", "forecasts",
"intends", "anticipates" or "does
not anticipate", or "believes" or variations
of such words and phrases or state that certain actions,
events or results "may", "could",
"would", "might" or "will be
taken", "occur" or "be achieved".
Forward-looking statements are subject to known and unknown
risks, uncertainties and other factors that may cause the
actual results, level of activity, performance or
achievements of Cynapsus to be materially different from
those expressed or implied by such forward-looking
statements, including but not limited to those risks and
uncertainties relating to Cynapsus' business disclosed
under the heading "Risk Factors" in Cynapsus' current
Annual Information Form and its other filings with the
various Canadian securities regulators which are available
online at www.sedar.com. Although Cynapsus has attempted to
identify important factors that could cause actual results
to differ materially from those contained in
forward-looking statements, there may be other factors that
cause results not to be as anticipated, estimated or
intended. There can be no assurance that such statements
will prove to be accurate, as actual results and future
events could differ materially from those anticipated in
such statements. Accordingly, readers should not place
undue reliance on forward-looking statements. Cynapsus does
not undertake to update any forward-looking statements,
except in accordance with applicable securities laws.
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