JERUSALEM, March 22, 2017 /PRNewswire/ --
Expects Phase I
Results in the Third Quarter of 2017
Intec Pharma Ltd. (Nasdaq; TASE: NTEC), a clinical stage
biopharmaceutical company focused on developing drugs based on its
proprietary Accordion Pill™ platform technology, announces the
initiation of a Phase I clinical trial of AP-CBD/THC, its Accordion
Pill platform with the two primary cannabinoids contained in
Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol
(THC), which is being developed by Intec for various indications,
including low back pain and Fibromyalgia.
The Cannabis sativa plant is used in treatment of chronic
pain and a variety of other indications. Previous clinical studies
conducted using the whole plant or specific extracts generated
evidence of the cannabis analgesic activity. Furthermore, extracts
containing known amounts of the active plant driven compounds
(mainly THC and CBD) or diverse synthetic THC derivatives are
promising treatments for painful conditions that do not respond
properly to currently available treatments, such as chronic,
neuropathic, and inflammatory
pain.[1],[2]
AP-CBD/THC holds the potential to address several major
drawbacks of current methods of use and treatment with cannabis and
cannabinoids, such as short duration of effect, delayed onset,
variability of exposure, variability of the administered dose and
adverse events that correlate with peak levels. AP-CBD/THC is
designed to extend the absorption phase of CBD and THC,
resulting-in more consistent levels, for an improved therapeutic
effect.
This Phase I trial is a single-center, single-dose, randomized,
three-way crossover study to compare the pharmacokinetics, safety
and tolerability of two formulations of AP-CBD/THC, with Buccal
Sativex®, in 21 normal healthy volunteers. Sativex is a
commercially available oral buccal spray containing CBD and
THC[3] . The Company expects to
have topline results from this trial in the third quarter of
2017.
"The progression of AP-CBD/THC into the clinic is a significant
achievement for Intec and marks a major step forward in developing
a potential new therapy for pain management. It is also our first
demonstration of the Accordion Pill platform for cannabinoid
therapies. Moving forward, we plan to evaluate the Accordion
Pill platform in several other indications where a safe, effective,
prolonged and consistent cannabinoid therapy may be able to provide
therapeutic benefit where other treatments have failed. We are very
pleased to have initiated our Phase I trial with AP-CBD/THC,"
stated Zeev Weiss, Chief Executive
Officer of Intec Pharma.
The cannabis market has significant commercial potential and is
projected to represent approximately 10% of the specialty
pharmaceutical market over the next five years, or a market of at
least $20 billion[4].
According to Global Data, in 2016 the global low back pain
drug market was $6.2 Billion and the
global Fibromyalgia drug market was $1.8
Billion.
Sativex® is a registered trademark of GW Pharmaceuticals.
About Intec Pharma Ltd.
Intec Pharma Ltd. 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 currently includes three product
candidates in clinical trial stages: Accordion Pill
Carbidopa/Levodopa, or AP-CDLD, which is being developed for the
indication of treatment of Parkinson's disease symptoms in advanced
Parkinson's disease patients, Accordion Pill Zaleplon, or AP-ZP,
which is being developed for the indication of treatment of
insomnia, including sleep induction and the improvement of sleep
maintenance, and an Accordion Pill that is being developed for the
prevention and treatment of gastroduodenal and small bowel
Nonsteroidal Anti-Inflammatory Drug (NSAID) induced ulcers.
About Low Back Pain
Approximately 80% of adults experience low back pain at some
point in their lifetimes. It is the most common cause of
job-related disability and a leading contributor to missed work
days. Men and women are equally affected by low back pain, which
can range in intensity from a dull, constant ache to severe pain
that causes incapacitation. Chronic back pain is defined as pain
that persists for 12 weeks or longer, even after an initial injury
or underlying cause of acute low back pain has been treated.
Approximately 20% of people affected by acute low back pain develop
chronic low back pain with persistent symptoms at one year. Low
back pain is ranked the third most burdensome conditions in the
U.S. in terms of mortality or poor health with only ischemic heart
disease and chronic obstructive pulmonary disease ranking higher.
Chronic low back pain requires extensive analgesic treatment
ranging from NSAIDs, anticonvulsants, antidepressants such as
tricyclics and serotonin and norepinephrine reuptake inhibitors
(SNRIs) up to opioids. Severe cases can require repeated nerve
blocks and surgery.
About Fibromyalgia
Fibromyalgia is a chronic musculoskeletal pain disorder that is
most prevalent in women. Fibromyalgia is thought to result from
amplified sensory and pain signaling. Fibromyalgia affects two to
5% of the adult U.S. population. Common symptoms of fibromyalgia
include chronic widespread pain, nonrestorative sleep, fatigue and
morning stiffness. Other associated symptoms include cognitive
dysfunction and mood disturbances, including anxiety and
depression. Individuals suffering from fibromyalgia often struggle
with their daily activities and have impaired quality of life and
frequently are disabled. Physicians and patients report
dissatisfaction with the current available treatment options for
fibromyalgia[5] .
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking statements about the
Company's 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 the company undertakes 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 the company's control.
Important factors that could cause actual results, developments and
business decisions to differ materially from forward-looking
statements are described in the sections titled "Risk Factors" in
the company's filings with the Securities and Exchange Commission,
and include the following: the company's ability to develop and
commercialize its product candidates and obtain additional
financing necessary therefor; the length, cost and uncertain
results of the company's clinical trials; the potential of adverse
side effects, other safety risks, or legal prohibitions on the use
of certain products in certain jurisdictions that could preclude
the approval of the company's drug candidates; the availability of
reimbursement from government authorities and health insurance
companies for the company's products; the impact of product
liability lawsuits; and the influence of extensive and costly
government regulation.
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1. J. Menzanares, Role of the Cannabinoid System in Pain Control
and Therapeutic Implications for the Management of Acute and
Chronic Pain Episodes, Curr Neuropharmacol. 2006 Jul; 4(3):
239-257.
2 Kevin P. Hill, Medical Marijuana for Treatment of Chronic Pain
and Other Medical and Psychiatric Problems A Clinical Review JAMA.
2015;313(24):2474-2483
3 Product information for Sativex. Bayer Healthcare:
Toronto, ON. April 13, 2005: http://www.bayer.ca.
4. Source: Viridian Capital Advisors. (2015, December
2). REPORT: The Cannabis biotech/Pharma market could surpass
$20 Billion by 2020. Retrieved
September 1, 2016, from Equities,
https://www.equities.com/news/report-the-cannabis-biotech-pharma-market-could-surpass-20-billion-by-2020.
5. Global Drug Forecast; 2015
Contacts:
Zeev Weiss
Chief Executive Officer
Intec Pharma
+972-(2)586-4657
zeev@intecpharma.com
Anne Marie Fields
Senior Vice President
LHA
212-838-3777
afields@lhai.com
SOURCE Intec Pharma Ltd.