JERUSALEM, June 19, 2019 /PRNewswire/ -- Intec Pharma
Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announced
that results from a pharmacokinetics (PK) study of the Accordion
Pill™-Carbidopa/Levodopa (AP-CD/LD) 50/500 mg dosed three times per
day (TID) were highlighted yesterday in a poster presentation
at the XXIV World Congress on Parkinson's Disease and
Related Disorders taking place June 16-19,
2019 in Montreal,
Canada.
C. Warren Olanow, M.D., Professor
and Chair Emeritus, Department of Neurology at Mount
Sinai School of Medicine, New York, was the Senior Author of
the Poster which is titled, "Pharmacokinetics of multiple doses of
Accordion Pill Carbidopa/Levodopa in patients with Parkinson's
disease." The poster can be accessed here.
The presentation highlighted data collected during a cross-over
PK study comparing AP-CD/LD 50/500 mg TID and standard immediate
release (IR) CD/LD 37.5/150 mg 5x daily in patients with PD. PK
samples were collected pre-dose and at 30-minute intervals
post-dose over 16 hours and again at 24 hours post-dose.
The primary endpoint of the study was the variability in plasma
LD concentration in steady state (between four and 16 hours) as
assessed by the LD fluctuation index
[(Cmax-Cmin)/Cavg)]. The key
secondary endpoint was the coefficient of variation (standard
deviation of plasma LD concentrations divided by the average
concentration). In addition, multiple sensitivity analyses were
performed.
The results showed that AP-CD/LD 50/500 mg TID met the study's
primary endpoint of reducing plasma levodopa variability compared
to standard IR-CD/LD when dosed five times per day
(p=0.0048). Less variability was also observed for the
coefficient of variation of plasma levodopa levels (key secondary
endpoint; p=0.047). These results were supported by the
findings of significant outcomes on each of the prespecified
sensitivity analyses. AP-CD/LD was well tolerated with no
serious adverse events.
The study authors noted that motor complications are associated
with variability in plasma levodopa concentration seen with IR
levodopa, and concluded that the results of the present study
"suggest that treatment with AP-CD/LD may reduce motor
complications in patients with advanced PD as compared to standard
IR-CD/LD treatment."
"We are delighted to have these positive PK results presented by
Dr. Olanow, a world-leading Parkinson's disease expert, at this
prestigious medical meeting. These PK results are important as
they confirm our expectations that AP-CD/LD 50/500 TID reduces
levodopa variability in PD patients, which we expect will translate
to a reduction in motor fluctuations in these patients,"
noted Jeffrey A. Meckler, Vice Chairman and Chief Executive
Officer of Intec Pharma. "We are eagerly awaiting the top-line
results from our Phase 3 ACCORDANCE trial in the July/August time
frame and these positive PK data support our belief that AP-CD/LD
treatment could provide Parkinson's disease patients with a better
baseline LD therapy to reduce motor complications."
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. In addition, the Company has a
feasibility agreement for the development of a custom-designed
Accordion Pill for a proprietary compound with Novartis
Pharmaceuticals and a research collaboration with Merck &
Co.
For more information, visit www.intecpharma.com. Intec Pharma
routinely posts information that may be important to investors in
the Investor Relations section of its 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 10-K
filed with the SEC on February 27, 2019, 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
646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.