JERUSALEM, Sept. 25, 2019 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces that two
posters highlighting data from the Company's Phase 3 clinical
development program for the Accordion Pill®
Carbidopa/Levodopa (AP-CD/LD), were presented yesterday at
the International Congress of Parkinson's and Movement
Disorder Society (MDS 2019) that was held from September
22-26, 2019 in Nice, France.
"We were delighted to present these two posters highlighting
AP-CD/LD at this leading Parkinson's disease (PD) medical meeting.
There was considerable interest in our work and we believe the data
underscored the potential of AP-CD/LD in PD while highlighting its
long-term safety data. We have initiated a formal process for
partnering AP-CD/LD in PD and this enhanced exposure will be
important as we seek to partner AP-CD/LD for continued late-stage
clinical development and commercialization in PD
patients," stated Jeffrey A.
Meckler, Vice Chairman and Chief Executive Officer of Intec
Pharma.
R. Michael Gendreau, M.D., Ph.D.,
Intec Pharma's Chief Medical Officer, presented a poster titled,
'Patients Experiencing Motor Fluctuations with Parkinson's
Disease: Participant Characteristics in the ACCORDANCE Phase 3
Efficacy and Safety Trial
of Accordion Pill®-Carbidopa/Levodopa,'
which provided baseline demographic and disease characteristics for
participants in the Company's Phase 3 ACCORDANCE study of AP-CD/LD
compared with immediate release carbidopa/levodopa (IR-CD/LD) in PD
patients. The poster also included discussion of key top-line
findings from the study.
The data showed that the demographic characteristics were well
matched between treatment groups, with most participants being
white and male, with a mean age of 62.8 years for those receiving
AP-CD/LD and 64.9 years for those receiving IR-CD/LD. The
baseline percentage of daily OFF time and daily OFF time in hours
were similar between treatment groups. Overall, participants
taking AP-CD/LD were optimized to and tolerated higher daily doses
of LD than those taking IR-CD/LD, with 86.2 percent of AP-CD/LD
participants optimized to ≥1200 mg LD compared with only 19.7
percent of IR-CD/LD participants optimized to ≥1200 mg
LD.
"The top-line results from the ACCORDANCE study showed that
AP-CD/LD was numerically superior in reducing daily OFF time but
was not statistically superior to IR-CD/LD. We believe the
double-blind results may have been confounded by data from
participants who titrated to the maximum available dose of AP-CD/LD
(50/500 mg TID) and, consequently, may not have achieved optimal
efficacy. We performed an ad hoc analysis of those
participants who had been titrated to AP doses less than the
maximum allowable dose (approximately 39% of the intention-to-treat
population) and those results showed a greater difference in mean
daily OFF time between AP-CD/LD and IR-CD/LD in participants who
were not dose limited during the AP titration process. This
suggests that for many participants, AP doses higher than those
available in this study may have been necessary to achieve optimal
efficacy," noted Dr. Gendreau.
Mr. Meckler presented a poster titled, "Pharmacokinetics of
Accordion Pill®-Carbidopa/Levodopa Following
Multiple Doses in Patients with Parkinson's
Disease," which reviewed the results of an open label,
cross-over, pharmacokinetic (PK) study comparing AP-CD/LD 50/500 mg
three times daily (TID) and IR-CD/LD 37.5/150 mg five times daily
in patients with PD.
The results of that PK study 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.
The two posters can be accessed on the Company's website
here.
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.