-- Webcast with
accompanying slides to discuss these findings tomorrow at 7:30 a.m.
Eastern time
Top-line CTH-300 results expected in late Q3 or early Q4 --
TORONTO, July 18, 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 positive
open-label dose titration phase (DTP) results from the ongoing
CTH-300 pivotal Phase 3 efficacy and safety trial (CTH-300).
CTH-300 enrollment was completed on June 30, 2016
with 102 PD patients entering open-label DTP. The DTP
part of CTH-300 is now complete, with data available from the first
92 patients. Remaining patient data will be entered upon
completion of their first post-randomization visit.
Preliminary CTH-300 open-label DTP highlights
include:
-
The mean change in Movement Disorder Society's
Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part
III) from baseline to 30 minutes was 22 points
-
In 60% of patients, improvement in motor
function was reported between 5 and 12 minutes after dosing.
-
Improvement in motor function was maintained
beyond 90 minutes with a mean improvement of the MDS UPDRS Part III
of 16 points at that time point
-
83% of patients entering the open-label
dose titration phase turned from OFF to fully ON
-
78% of patients entering the open-label dose
titration phase turned fully ON within 30 minutes; approximately
38% were fully ON at 15 minutes
-
The median dose of APL-130277 turning patients
to fully ON was 20mg
-
APL-130277 was well tolerated. During the dose
titration period: 16% of patients reported nausea that was mostly
mild in intensity; 8% of patients reported dizziness; 4% of
patients reported somnolence; 2% of patients reported vomiting; and
1% of patients reported symptomatic hypotension
-
There were no reports of local irritation during
the open-label DTP of the CTH-300 study
-
A total of 16 patients were dosed and did not
complete the DTP of the study; five (5) of such patients
discontinued due to an adverse event, nine (9) of such patients
discontinued because the highest dose in this study was not
sufficient to turn them from OFF to ON within 45 minutes and two
(2) of such patients discontinued for administrative reasons.
"Top-line results from the DTP of CTH-300
corroborate our Phase 2 findings supporting the potential benefit
of APL-130277 as an on-demand therapy for the management of OFF
episodes in patients with Parkinson's disease who suffer motor
fluctuations," said Dr. Albert Agro, Chief Medical Officer of
Cynapsus. "The robustness of this preliminary clinical data,
particularly the 22-point improvement in MDS-UPDRS Part III, gives
us confidence that our sample size of 80 patients randomized, is
more than sufficient to show statistical and clinical meaningful
changes at 90% power in our primary and key secondary clinical
endpoints."
Figure 1 (below)
demonstrates the change from baseline of the MDS-UPDRS Part III
score at 15, 30, 45, 60 and 90 minutes post-dosing^
An infographic accompanying this release is
available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/8519ce7b-088c-4b6c-8337-d404024044ea
^Data captured is based on patients existing in
the database as of July 15, 2016
Table 1
Illustrates the most common dopaminergic Adverse Events (AE) seen
in CTH-300 Dose Titration Phase (n=92)*
N=92 |
Number of Patients with an Adverse Event |
Any
AE |
Mild
AE |
Moderate AE |
Severe AE |
N
(%) |
N
(%) |
N
(%) |
N
(%) |
Nausea |
15 (16) |
12 (13) |
2 (2) |
1 (1) |
Dizziness |
7 (8) |
4 (4) |
3 (3) |
0 (0) |
Somnolence |
4 (4) |
3 (3) |
1 (1) |
0 (0) |
Yawning |
3 (3) |
3 (3) |
0 (0) |
0 (0) |
Vomiting |
2 (2) |
1 (1) |
1 (1) |
0 (0) |
Symptomatic
Hypotension |
1 (1) |
1 (1) |
0 (0) |
0 (0) |
Stomatitis/
Irritation |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
* Data not
final and subject to change
"The results seen in the open label dose titration
period of CTH-300 are an important step in confirming earlier data
that demonstrated that APL-130277 can provide PD patients with a
safe, tolerable and rapid improvement in motor function during OFF
episodes," said Anthony Giovinazzo, President and CEO of Cynapsus.
"We look forward to the completion of CTH-300 and preparing the
overall study results for our NDA submission. APL-130277 is
being developed to address a significant unmet need facing people
with Parkinson's disease. The preliminary results from CTH-300
DTP lead us to believe that APL-130277 may be able to fulfill the
unmet needs of Parkinson's patients seeking to better manage their
motor fluctuations."
These Phase 3 dose titration results are only a
snap shot and the final data and results from the Phase 3 study,
when released, could differ from such results.
Phase 3 Program Study
Design
The CTH-300 study is a double-blind,
placebo-controlled, parallel-design, two-part study. The
study enrolled eligible PD patients and 102 patients entered the
Open Label DTP. In the DTP, patients arrived to the clinic in the
practically defined OFF state (withholding their morning dose of PD
medications) and received the lowest dose of APL-130277 (10mg).
Patients were assessed to determine if successful conversion from
OFF to full ON occurred. If a full ON was not achieved, patients
returned to the clinic on subsequent visits and received a higher
dose of APL-130277 (at 5mg increments, up to 35mg) until the
effective conversion dose was identified. Those patients that
turned fully ON with a dose of APL-130277 during the DTP proceeded
to the dose randomization part of the study where they were
randomized to receive either the effective dose or placebo. The
objective of the second part of CTH-300 is to evaluate the
efficacy, safety and tolerability of APL-130277 versus placebo in
patients with PD over a 12-week period. CTH-300 is well
powered to demonstrate statistical significant reduction in
MDS-UPDRS Part III with 80 patients randomized. A sample size of 80
randomized patients allows for greater than 90% power to achieve
statistical significance at the primary and key secondary
endpoint. The primary endpoint is mean change in the
MDS-UPDRS Part III score at 30 minutes after 12 weeks of at-home
dosing.
The CTH-301 Phase 3 Safety Study (CTH-301) is a
long-term open-label, single arm safety study in PD patients who
have at least one OFF episode per day, with total OFF time of at
least two hours per day. The objective is to evaluate the safety
and tolerability of APL-130277 in up to 200 patients with PD over a
six-month period. Patients completing CTH-300 are eligible to
enter CTH-301. In addition, de novo patients from approximately 65
sites in North America and Europe will be enrolled in CTH-301.
Data from CTH-300 and CTH-301 are expected to form
the basis for the registration package necessary for a 505(b)(2)
New Drug Application (NDA) with the U.S. Food and Drug
Administration expected to be submitted in the first half of
2017.
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 PD. It
is a chronic, progressive neurodegenerative disease characterized
by motor symptoms, including tremor at rest, rigidity and impaired
movement, as well as significant non-motor symptoms, including
cognitive impairment and mood disorders. PD's prevalence is
increasing with the aging of the population. OFF episodes are
a complication of the disease. An estimated one quarter to one half
of all people with PD 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 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, which can be painful and difficult
to administer, particularly while suffering an OFF episode.
Cynapsus' APL-130277 product candidate is a
sublingual formulation of apomorphine for the treatment of OFF
episodes. 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 an analyst meeting
and live webcast with accompanying slides to discuss these findings
tomorrow at 7:30 a.m. Eastern time. To view the live webcast, visit
the Investor Relations section of the Company's website
at www.cynapsus.ca.
A replay of the webcast will be available 2 hours
after completion of the meeting, and archived for 90 days on the
Company's website at www.cynapsus.ca in the Investor
Relations section.
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 drug
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 in the first half of 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 in the first half of 2017; expectations regarding the
Company's clinical and regulatory activities, including without
limitation, the anticipated timing, completion and results of Phase
3 and other clinical studies; and beliefs related to potential
benefits, effectiveness and demand for, the Company's 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-Q for the
quarter ended March 31, 2016 filed with the United States
Securities and Exchange Commission (the "SEC") on May 11, 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) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Cynapsus Therapeutics Inc. via Globenewswire
HUG#2029263
Citigroup Fdg (AMEX:CTH)
過去 株価チャート
から 5 2024 まで 6 2024
Citigroup Fdg (AMEX:CTH)
過去 株価チャート
から 6 2023 まで 6 2024