JERUSALEM, April 30, 2019 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces that the
last patient has completed their final visit in the Company's
pivotal Phase 3 trial (the ACCORDANCE trial) evaluating the safety
and efficacy of the Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD)
compared with immediate release CD/LD (IR-CD/LD;
Sinemet®) as a treatment for the symptoms of advanced
Parkinson's disease (PD). The study enrolled 462 patients
into the Sinemet titration and optimization period and randomized
320 patients into the double-blinded portion of the study. The
clinical data and patient diaries are currently in the process of
being validated and top-line results are expected to be announced
in the July/August time frame, subject to successful database lock
and results validation.
"We are excited to announce that the last patient's last visit
has taken place as it is an important milestone in the development
of our Accordion Pill platform. Completion of the ACCORDANCE study
brings us closer to potentially providing an enhanced baseline
levodopa treatment to advanced PD patients," stated R. Michael Gendreau, M.D., Ph.D., Chief Medical
Officer of Intec Pharma. "By delivering more uniform levodopa
plasma concentrations than those provided by currently available
orally-administered levodopa products, we expect to improve
the duration and consistency of symptom relief provided by
levodopa. Assuming successful ACCORDANCE study outcomes, we
believe the AP-CD/LD will result in improved motor fluctuation
control, reduced symptomology, a simpler dosing regimen and
enhanced compliance."
"With topline results expected this summer, we are actively
making plans for our regulatory submissions. Toward that end,
we are encouraged that more than 90% of eligible patients elected
to enroll in the AP-CD/LD long-term open-label extension (OLE)
study as these data will provide the long-term safety required as
part of the registration package. In addition, we have made
significant progress with our commercial scale manufacturing plans
and expect to initiate the validation, bridging and stability
studies in the coming months," said Jeffrey
A. Meckler, Vice Chairman and Chief Executive Officer of
Intec Pharma.
"The positive readout from our pharmacokinetic (PK) study of
AP-CD/LD 50/500 mg dosed three times daily (TID), which
demonstrated a statistically significant reduction in the
variability of plasma LD concentration compared with IR-CD/LD dosed
five times daily, continues to build on our body of data in support
of AP-CD/LD as a potentially better baseline levodopa
therapy. We look forward to receiving the results from the
ACCORDANCE trial and, if successful, having them confirm that
treatment with AP-CD/LD reduces motor complications in advanced PD
patients in comparison to treatment with standard oral levodopa,"
added Mr. Meckler.
About the Phase 3 ACCORDANCE Clinical Trial
The Phase 3 ACCORDANCE clinical trial of AP-CD/LD is a
multi-center, global, randomized, double-blind, double-dummy,
active-controlled, parallel-group study in adult subjects with
advanced PD. The study is being conducted at approximately 90
clinical sites throughout the U.S., Europe and Israel.
Prior to the 13-week randomized portion of the study, the
ACCORDANCE study had two open label periods of 6 weeks each during
which all patients in these open label periods were first
stabilized and optimized on the active comparator, Sinemet, and
then on AP-CD/LD.
The primary efficacy endpoint of the study is the change from
baseline to endpoint in the percent of daily OFF time during waking
hours based on Hauser home diaries. The study is 90% powered to be
statistically significant for a one-hour difference in OFF time
between Sinemet and AP-CD/LD.
Secondary endpoints include change from baseline to endpoint in
ON time without troublesome dyskinesia during waking hours, CGI-I
at endpoint as recorded by physician and patient, and change from
baseline through endpoint in the Unified Parkinson's Disease Rating
Scale (UPDRS) Score Parts 2 and 3.
Preliminary analysis of the baseline data for the patient
population shows:
- Average age at study enrollment was 63 and 66% of enrolled
patients were male;
- Patients enrolled had a diagnosis of PD for 8.7 years on
average;
- Average daily OFF time for patients following the Sinemet
titration/optimization period was approximately 5.0 hours;
- More than 70% of patients completing the open label Sinemet
titration/optimization period were optimized on 800 mg daily of
levodopa or greater;
- More than 85% of patients completing the open label Accordion
Pill titration/ optimization period were optimized on AP-CD/LD
TID;
- Approximately 31% of patients were enrolled in the
U.S.
All patients completing the 13-week randomized period are
eligible to continue in an OLE study in which they will receive
treatment with AP-CD/LD for an additional 12 months. To date, more
than 90% of eligible patients have elected to enter the OLE
study.
About the Accordion Pill Technology
The Accordion Pill is a drug delivery system that uses
biodegradable polymeric films, which combine and load drugs and
actives 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 pill is done, it simply dissolves
in the GI tract.
About AP-CD/LD
The Accordion Pill Carbidopa/Levodopa (AP-CD/LD) is a
gastric-retentive drug delivery system containing carbidopa and
levodopa in both immediate and extended-release modes. The
innovative gastric retentive qualities of AP-CD/LD provide
extended-release levodopa to be discharged slowly in the stomach
over 8–12 hours, allowing the active ingredients to be absorbed
more steadily in the upper GI tract, where levodopa is
absorbed. This results in a more stable and predictable PK
profile.
About Parkinson's Disease
Parkinson's disease is the second most common neurodegenerative
disorder in the elderly, and it is estimated to affect more than
two million people in the U.S. and Europe. There are estimated to be more than
600,000 Parkinson's disease patients in the U.S. who experience
motor fluctuations, a condition where with disease progression
patients experience both "wearing off" (where they have trouble
with movement), and "dyskinesias" or uncontrolled movements. More
than 400,000 of these patients in the U.S. experience in excess of
one hour per day of motor fluctuations.
The majority of Parkinson's disease patients are treated with
LD. However, LD treatment is often associated with motor
complications, mainly wearing "OFF" periods and LD-induced
dyskinesia.
The efficacy and adverse effects of LD are directly related to
plasma levels of the drug. Current formulations of LD provide
only limited efficacy as LD has a very short half-life of
approximately 90 minutes and its absorption is confined to the
upper part of the gastrointestinal tract (narrow absorption
window). Consequently, stabilizing LD plasma levels remains a
major factor for improving anti-parkinsonian control in advanced
Parkinson's disease patients.
Sinemet® is a registered trademark of Merck & Co.,
Inc.
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.
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.