JERUSALEM, July 1, 2019 /PRNewswire/ -- Intec
Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today
announced that a review highlighting the benefits of the Accordion
Pill® (AP) oral drug delivery platform was published in
the peer-reviewed journal, Therapeutic Delivery. The
article titled, "The Accordion Pill®: unique oral
delivery to enhance pharmacokinetics and therapeutic benefit of
challenging drugs," highlights the technical and clinical
achievements of the AP platform in a variety of
applications. The article is now available online as an
e-publication ahead of print and can be accessed here.
The AP is an oral drug delivery system that uses biodegradable
polymeric films, which combine and load drugs and inactive
ingredients onto the films, folds the films 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 retention properties. With the AP, drug is released slowly
in the stomach over hours, allowing the body to absorb it more
steadily. The unique gastric retention performance of the platform
is due to the size, shape and mechanical properties of the physical
multilayer structure which unfolds to a planar structure once it
reaches the stomach.
A variety of Phase 2 clinical studies of AP have demonstrated
gastric retention and improved pharmacokinetic (PK) properties for
several drugs including those with a narrow absorption window,
narrow therapeutic window and/or poor solubility.
"The AP facilitates the development of molecules with poor
solubility and permeability and the enhancement of drugs that
suffer from a narrow absorption window and short half-life, leading
to the possibility of better dosage forms, new indications and
potentially better safety profiles," stated Nadav Navon, Ph.D., Chief Operating Officer of
Intec Pharma and author of the journal article. "Based on the
performance characteristics of the AP, we have advanced
AP-Carbidopa/Levodopa (AP-CD/LD) to a late-stage Phase 3 clinical
study in Parkinson's disease (PD). We also have engaged in a
feasibility agreement for the development of a custom-designed AP
for a proprietary compound with Novartis Pharmaceuticals and a
similar type of research collaboration with Merck & Co."
In Phase 2 studies in PD patients, AP-CD/LD produced stable LD
plasma concentrations and provided daily coverage of LD therapeutic
plasma levels that resulted in significantly less total daily OFF
time in comparison with those receiving an active control or their
current treatment. In addition, AP formulation of a poorly soluble
drug demonstrated an extended absorption phase and greater exposure
compared with the commercial formulation of the drug.
"We are pleased to have this review of the AP platform's
capabilities published in a peer-reviewed journal article as it
enhances awareness of the flexibility and versatility of AP to
address a number of challenges in the delivery of poorly soluble
drugs and/or drugs with a narrow absorption window," commented
Jeffrey A. Meckler, Vice Chairman
and Chief Executive Officer of Intec Pharma. "We are
well-positioned to build upon our AP drug delivery technology
platform with partner-sponsored R&D programs, such as the
Novartis and Merck collaborations, as well as with internally-led
drug reformulation programs. Our AP platform offers multiple
opportunities to enhance the characteristics of a wide variety of
proprietary compounds and develop innovative approaches for the
treatment of diseases with its unique gastric retention
platform."
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
+1-646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.