JERUSALEM, Feb. 19, 2019 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces the
preliminary results from a pharmacokinetic (PK) study comparing the
Company's Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) 50/500mg
dosed three times daily (TID) to 1.5 tablets of CD/LD
immediate release (Sinemet™) 25/100 dosed five times per day in
Parkinson's disease (PD) patients. The Company plans to submit the
full data set for potential presentation and publication at a major
medical meeting and in a peer review journal,
respectively.
"We are very excited by the results of this PK study of AP-CD/LD
50/500 TID, the most common dose used in our on-going Phase 3
ACCORDANCE study, which showed that the AP platform technology
provides a significantly more stable plasma levodopa level when
compared with routine oral administration of CD/LD," stated R.
Michael Gendreau, M.D., Ph.D., Chief
Medical Officer of Intec Pharma.
The object of this open-label, crossover PK study was to compare
the plasma levodopa variability in 12 PD patients treated with
standard levodopa therapy and with AP-CD/LD 50/500 mg TID. On
Day one, all participants received 1.5 tablets of standard Sinemet
25/100 mg five times at approximately three-hour intervals.
Advanced Parkinson's patients often receive more than three doses
per day of standard levodopa therapy such as
Sinemet. Plasma was collected for PK determination at
30-minute intervals for 16 hours in the clinic. This period
provided the reference PK profile for Sinemet. On Days two through
seven, PD patients were treated at home with AP-CD/LD 50/500 mg
capsules dosed TID, at approximately five-hour intervals. On Day
eight, participants returned to the clinic and PK assessments were
repeated as described above.
The primary outcome measure in this study was the fluctuation
index [(Cmax-Cmin)/Cavg] in plasma
levodopa concentration at steady state (between hours four and
16.) The key secondary endpoint was the levodopa coefficient
of variation.
AP-CD/LD 50/500 mg TID met its primary endpoint demonstrating
significantly less variability than standard oral CD/LD when dosed
5x/ day in the levodopa fluctuation index (p<0.005). These
results were supported by the findings of significant outcomes on
each of the prespecified sensitivity analyses. Similar
results were observed for the key secondary endpoint of coefficient
of variation of plasma levodopa levels (p<0.047). AP-CD/LD
was very well tolerated with no reported adverse events. (See
Table 1.)
Table 1
|
Primary
Endpoint:
Levodopa
Fluctuation Index at Steady State (4-16 Hours)
|
Treatment/
Difference
|
Mean
Value
|
95% Confidence
Interval
|
p-Value
|
Sinemet
(IR-CD/LD)
|
2.22
|
1.82 –
2.62
|
--
|
Accordion
AP-CD/LD
|
1.59
|
1.23 –
1.95
|
--
|
Difference
|
0.63
|
0.24 –
1.03
|
0.005
|
"Clinical studies have consistently demonstrated that reduced
variability in plasma levodopa concentration is associated with
reduced motor complications. Based on the PK results from
this study, it is reasonable to consider that treatment with
AP-CD/LD capsules should be associated with reduced motor
complications in PD patients in comparison to treatment with
standard oral levodopa. We are looking forward to the results
of the Phase 3 ACCORDANCE trial testing this hypothesis," noted C.
Warren Olanow, M.D., Professor and
Chair Emeritus, Department of Neurology Mt. Sinai School of
Medicine, New York.
"We are delighted with these PK results as they confirm our
expectations that AP-CD/LD 50/500 TID would reduce levodopa
variability in PD patients, which should potentially reduce motor
fluctuations in these patients. These fluctuation data are
consistent with the results from an earlier eight-patient PK study
evaluating AP-CD/LD 50/375 mg dosed twice a day. That
previous study gave a fluctuation index difference of approximately
0.8, largely due to greater variance with the immediate release
treatment," said Jeffrey A. Meckler,
Vice Chairman and Chief Executive Officer of Intec Pharma.
"We are enthusiastically awaiting our Phase 3 ACCORDANCE results
in mid-2019 and hope to bring AP-CD/LD treatment to Parkinson's
patients as a new baseline therapy with the potential to reduce
motor complications," added Mr. Meckler.
Sinemet™ is a trademark of Merck & Co., Inc.
About Accordion Pill Platform Technology
The
Accordion Pill is a drug delivery system that uses biodegradable
polymeric films, which combine and load drugs and inactive
ingredients onto these films, folds them into an undulated shape
and then places them inside a capsule. This innovative drug
delivery system has a number of unique advantages based on its
gastric retentive properties. With the Accordion Pill, drug is
released slowly in the stomach over hours, allowing the body to
absorb it more steadily. When the Accordion Pill is evacuated from
the stomach, it simply dissolves in the GI tract.
The Accordion Pill's drug release mechanism is independent of
its gastric retention mechanism and the Accordion Pill can combine
immediate and controlled-release profiles, thus allowing
considerable flexibility in developing and/or optimizing a variety
of therapies.
This novel drug delivery system can improve PK, allows for high
drug loading and is ideally suited for compounds with narrow
absorption windows, poor solubility or that act locally in the
stomach or upper gastrointestinal area. Importantly, the
Accordion Pill's safety and efficacy have been tested in more than
30 clinical studies since Intec's inception.
About Intec Pharma Ltd.
Intec Pharma is a
clinical-stage biopharmaceutical company focused on developing
drugs based on its proprietary Accordion Pill platform technology.
The Company's Accordion Pill is an oral drug delivery system that
is designed to improve the efficacy and safety of existing drugs
and drugs in development by utilizing an efficient gastric
retention and specific release mechanism. The Company's product
pipeline includes two product candidates in clinical trial stages:
Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in
late-stage Phase 3 development for the treatment of Parkinson's
disease symptoms in advanced Parkinson's disease patients, and
AP-cannabinoids, an Accordion Pill to deliver either or both of the
primary cannabinoids contained in Cannabis sativa, cannabidiol
(CBD) and tetrahydrocannabinol (THC) for various pain
indications.
For more information, visit www.intecpharma.com. We routinely
post information that may be important to investors in the Investor
Relations section of our website.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward
looking statements about our expectations, beliefs and intentions.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe", "expect", "intend",
"plan", "may", "should", "could", "might", "seek", "target",
"will", "project", "forecast", "continue" or "anticipate" or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. These forward-looking statements are based on
assumptions and assessments made in light of management's
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties, many of which are outside of our control. Many
factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements, including, but not limited to, the
following: our limited operating history and history of operating
losses, our ability to continue as a going concern, our ability to
obtain additional financing, our ability to successfully operate
our business or execute our business plan, the timing and cost of
our clinical trials, the completion and receiving favorable results
in our clinical trials, our ability to obtain and maintain
regulatory approval of our product candidates, our ability to
protect and maintain our intellectual property and licensing
arrangements, our ability to develop, manufacture and commercialize
our product candidates, the risk of product liability claims, the
availability of reimbursement, and the influence of extensive and
costly government regulation. More detailed information about the
risks and uncertainties affecting us is contained under the heading
"Risk Factors" included in our most recent Annual Report on Form
20-F filed with the SEC on March 9, 2018, and in
other filings that we have made and may make with
the Securities and Exchange Commission in the future.
Intec Pharma Investor Contact:
Anne Marie
Fields
VP-Corporate Communications & Investor Relations
+1-646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.