Clinically meaningful improvement in motor
control occurred in as early as 10 minutes after administration of
APL-130277 and lasted longer than 90 minutes
Conference call begins at 8:00 a.m. Eastern
time today
Cynapsus Therapeutics Inc. (CTH:TSX-V) (CYNAF:OTCQX), a
specialty pharmaceutical company focused on Parkinson’s disease,
today announced positive top-line results from its CTH-105 Phase 2
clinical trial of APL-130277 for the management of OFF motor
symptoms of Parkinson’s disease.
APL-130277 is the Company’s fast-acting, sublingual, thin
filmstrip formulation of apomorphine. OFF episodes are a
complication of Parkinson’s disease that leave patients rigid and
unable to move and communicate. 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.
Highlights of the CTH-105 study results include:
- Out of 16 patients treated with
APL-130277, 14 converted from OFF to ON, suggesting that APL-130277
may effectively manage OFF episodes in patients with Parkinson’s
disease
- Preliminary data show that several
subjects converted to ON with the 10mg low dose, and 14 of 16
subjects converted ON with all available doses (i.e. 10, 15, 20, 25
and 30mg)
- Clinically meaningful improvement in
motor control occurred in as early as 10 minutes after
administration of APL-130277 and lasted longer than 90 minutes
- The maximum mean change from baseline
UPDRS III was 18.4, which is a large clinically important
difference
- APL-130277 treatment was safe and well
tolerated, with no local irritation, no postural hypotension and a
low number of nausea events
“The purpose of the CTH-105 study was to better understand the
APL-130277 dose range that produced efficacy as measured by the
change in the Unified Parkinson’s Disease Rating Scale (UPDRS) part
III, a scale used by neurologists to measure the severity of
Parkinson’s disease OFF and motor symptoms, compared with baseline.
We are encouraged that APL-130277 provided clinical benefit at all
five doses used in this study,” said Dr. Albert Agro, Chief Medical
Officer of Cynapsus. “These preliminary data show that APL-130277
was able to convert patients from a severe OFF state in the morning
to ON. In addition, treatment was associated with a 45% improvement
in motor function based on the change in UPDRS part III from
baseline. The mean dose needed to terminate the OFF episode was
18.4mg. In addition, those patients achieving a response at higher
doses appeared to adapt to the treatment, as seen by the lack of
nausea at higher doses.”
Phase 2 Study Design
In the CTH-105 multicenter open-label study, APL-130277 was
assessed in 16 patients with Parkinson’s disease who experience the
debilitating effects of OFF episodes, with a total duration of OFF
of at least two hours daily. To date, 16 patients have completed
the dosing regimen, which was the planned sample size for the
study. Due to over enrollment, an additional three patients are
still in dosing. OFF episodes were achieved by having patients take
their last dose of levodopa the night before they came into the
clinic. Patients were not allowed to take their first dose of
levodopa in the morning, resulting in a severe OFF state that is
one of the most difficult to convert and maintain in an ON state.
Patients were then given escalating doses of APL-130277 (at a
minimum of three hours between doses) until ON was achieved, as
documented by study staff, the patient, and a clinician assessment
of UPDRS part III. The UPDRS III part score was measured at 15, 30,
45, 60 and 90 minutes.
Phase 2 Study Results
All five doses of APL-130277 used in the study (10, 15, 20, 25
and 30mg) resulted in patients moving from OFF to ON. The mean
baseline UPDRS part III in an OFF state was 41.4, and the maximum
mean change from baseline UPDRS part III was 18.4. The mean dose
required to convert patients to ON was 18.4mg. The onset of a
clinically meaningful improvement was seen in as early as 10
minutes and lasted up to 90 minutes, the last time point measured
in this study. The mean time to ON as reported by study staff was
22 minutes. Cynapsus believes that these data strongly support the
conclusion that APL-130277 is associated with the robust and rapid
management of OFF episodes.
The graph below (click the multimedia link) shows the mean
change from baseline in UPDRS part III for the 14 subjects who
converted to ON. Two patients dosed at the highest available dose
(30mg) did not achieve a full ON as assessed by the investigator,
suggesting that higher doses may be required for some patients.
Treatment with APL-130277 was safe and well tolerated. Nausea
was reported by three subjects at doses of 10, 15 and 20mg. One of
these patients also experienced a mild episode of emesis. There
were no reports of nausea at higher doses. There were no reports of
local irritation or hypotension in any subject treated. A total of
60 doses of APL-130277 were administered to the 16 patients who
completed dosing in the CTH-105 study.
Based on the findings of this study, Cynapsus is planning to
conduct pivotal studies of longer duration and with larger patient
numbers to confirm these results. These pivotal studies are
expected to form the registration package necessary for a 505(b)(2)
New Drug Application with the U.S. Food and Drug Administration
expected to be submitted in 2016.
“The results of this Phase 2 trial are important as the data
show that APL-130277 provided Parkinson’s patients with a rapid
improvement in motor function during OFF episodes,” said Anthony
Giovinazzo, President and CEO of Cynapsus. “APL-130277 is being
developed to address a significant unmet need facing people with
Parkinson’s disease today. The CTH-105 trial results lead us
to maintain that APL-130277 may be able to serve the majority of
Parkinson’s patients seeking to restore movement rapidly, on
demand, with an easy to retrieve and to administer form of
apomorphine, the only approved and most efficacious drug for this
purpose.”
“OFF episodes are debilitating events for people with
Parkinson’s disease. A recent survey by The Michael J. Fox
Foundation of 3,000 Parkinson’s patients revealed that nearly half
said their OFF time was moderate or severe, causing them to avoid
or stop activities," said Dr. Todd Sherer, CEO of The Michael J.
Fox Foundation for Parkinson's Research, which provided $500,000 in
funding for this study. “A rapid and reliable therapy that can
address OFF episodes would be a major advancement in treatment.
These results suggest that APL-130277 could provide patients with
improved quality of life, and as supporters of this program from
its early days, we look forward to continued success in Phase 3
trials.”
About Parkinson’s Disease and OFF Episodes
More than 1 million people in the U.S. and an estimated 4 to 6
million people globally suffer from 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. OFF
episodes are a complication of Parkinson’s disease that leave
patients rigid and unable to move and communicate. 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.
OFF and motor symptoms of Parkinson’s disease are measured by
UPDRS part III. The UPDRS is used by neurologists to measure the
severity of Parkinson’s disease.
About Apomorphine
Apomorphine is the only drug that can rapidly convert a patient
from OFF (unable to move) to ON (fully functional). Unfortunately
for Parkinson’s patients, apomorphine is currently only available
only as an injection, which can be painful and difficult to
administer, particularly while suffering an OFF episode.
Cynapsus’ APL-130277 drug candidate is the only oral formulation
of apomorphine for the treatment of OFF episodes. APL-130277 is a
strip that a Parkinson’s patient can place under his or her tongue
when an OFF episode is starting. If approved, APL‐130277 will
provide patients with a convenient and easy alternative to multiple
daily injections.
Conference Call and Webcast
Cynapsus management will host a conference call with
accompanying slides to discuss these findings and answer questions
today at 8:00 a.m. Eastern time. Shareholders and other interested
parties can participate in the call by dialing 888-883-4599
(domestic) or 484-653-6821 (international) and referencing
conference ID number 37666252. The call and slides will also be
webcast live on the Company's website at www.cynapsus.ca on the
Calendar and Alerts page under Investor Relations.
A replay of the conference call will be accessible beginning two
hours after its completion through November 26, 2014 by dialing
855-859-2056 (domestic) or 404-537-3406 (international) and
referencing conference ID number 37666252. The call and slides will
also be archived for 90 days on the Company's website at
www.cynapsus.ca on the Calendar and Alerts page under Investor
Relations.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a
sublingual thin filmstrip for the acute rescue of OFF motor
symptoms of Parkinson’s disease. Cynapsus’ drug candidate,
APL-130277, is an easy-to-use, fast-acting formulation of
apomorphine, which is the only approved drug (in the United States,
Europe, Japan and other countries) to rescue patients from OFF
episodes. Cynapsus is focused on maximizing the value of
APL-130277 by completing pivotal studies in advance of a 505(b)(2)
New Drug Application (NDA) expected to be submitted in 2016.
More information about Cynapsus is available at www.cynapsus.ca
and at the System for Electronic Document Analysis and Retrieval
(SEDAR) at www.sedar.com.
Forward Looking Statements
This announcement contains "forward-looking statements" within
the meaning of applicable securities laws. 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 its March 26, 2014, 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.
Neither the TSX Venture Exchange nor the OTCQX International has
approved or disapproved of the contents of this press release.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20141119005236/en/
Cynapsus TherapeuticsAnthony Giovinazzo, 416-703-2449
x225President and CEOajg@cynapsus.caorAndrew Williams, 416-703-2449
x253COO & CFOawilliams@cynapsus.ca
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