JERUSALEM, July 22, 2019 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces top-line
data from 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 company announced that the ACCORDANCE study did not
achieve statistical superiority to Sinemet on the primary endpoint
of reduction in daily OFF time.
Levodopa is the most widely used and most effective drug for the
symptomatic therapy of PD. However, chronic levodopa therapy is
problematic due to the development of motor complications, which
can be disabling, difficult to treat, and may limit the usefulness
of the drug. OFF periods and dyskinesia are some of the most
prevalent motor complications for advanced PD patients and they
have a significant impact on quality-of-life and healthcare
costs.
Key Findings of the ACCORDANCE Trial
- AP-CD/LD provided treatment for Parkinson's disease symptoms
but did not demonstrate a statistically significant reduction in
OFF time over that obtained with IR-CD/LD under the conditions
established in the protocol.
- Treatment-emergent adverse effects (TEAEs) observed with
AP-CD/LD were generally consistent with the known safety profile of
CD/LD formulations and no new safety issues were observed
throughout the double-blinded study, during the gastroscopy safety
sub-study or the 12-month open-label extension (OLE) study.
"We are disappointed that the ACCORDANCE study didn't meet its
target endpoints with statistical significance. While the data
suggests that the AP CD/LD did achieve an acceptable safety profile
and did treat Parkinson's disease symptoms, it did not achieve a
statistically significant superiority to standard immediate release
levodopa therapy. We are pleased with the good safety profile
of the AP-CD/LD, as it demonstrates for the first time the
long-term safety of the Accordion Pill, which is important for
future potential applications and partnerships," stated
Jeffrey A. Meckler, Vice Chairman
and Chief Executive Officer of Intec Pharma.
"We sincerely thank the patients, families and clinical trial
sites involved in this study for their commitment to advancing
research in Parkinson's disease. We hope the body of clinical data
we have gathered can ultimately be used to benefit PD patients,"
stated R. Michael Gendreau, Chief
Medical Officer of Intec Pharma. "Upon our on-going preliminary
review of the data, we have noted that certain subsets of patients
performed particularly well. In those patients, we see a
meaningful reduction in OFF time. We will continue to analyze
the full data set and expect that such findings will help inform
our strategy for AP-CD/LD moving forward."
The ACCORDANCE Phase 3 Clinical Trial
Study Design
The Phase 3 ACCORDANCE study is a multi-center, global,
randomized, double-blind, double-dummy, active-controlled,
parallel-group study in adult subjects with advanced PD. The study
was conducted at over 90 clinical sites throughout the U.S.,
Europe and Israel. Prior to the 13-week randomized and
double-blinded 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 then optimized
on the active comparator, Sinemet, and then on AP-CD/LD. The study
enrolled 462 patients in the Sinemet titration period to provide
for the 320 patients that were randomized into the 13-week,
double-blinded portion of the study.
All patients completing the 13-week randomized period were
eligible to continue in an open-label extension study in which they
receive treatment with AP-CD/LD for an additional 12 months. More
than 90% of eligible patients elected to enter the OLE study.
Primary and Secondary Endpoints
The primary efficacy endpoint of the study was the change from
baseline to endpoint in the percent of daily OFF time during waking
hours based on Hauser home diaries. The study was 90% powered to
detect a one-hour difference in OFF time between Sinemet and
AP-CD/LD. Under the protocol and conditions of the ACCORDANCE
study, AP CD/LD did not demonstrate statistical superiority to
Sinemet on daily OFF time.
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. AP-CD/LD also did not
achieve statistical superiority on these endpoints.
Safety and Tolerability
Treatment-emergent adverse effects observed with AP-CD/LD were
generally consistent with the known safety profile of CD/LD
formulations. No new safety issues were observed throughout the
double-blinded study, during the gastroscopy safety sub-study or
the 12-month open-label extension (OLE) study.
Conference Call Information
Intec Pharma will hold a conference call and live audio webcast
on Monday, July 22, 2019 at
8:30 a.m. Eastern Time to discuss the
top-line results of this trial. To participate, please dial
877-552-1225 (domestic) or 270-215-9857 (international) and refer
to conference ID 1575693. To access the webcast, please click
here.
The live webcast can also be accessed under "Events and
Presentations" in the Investors section of Intec Pharma's website
at www.intecpharma.com. The archived webcast will be available
on the website beginning approximately two hours after the event
for 90 days.
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 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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