JERUSALEM, March 29, 2017 /PRNewswire/ --
Intec Pharma Ltd. (Nasdaq; TASE: NTEC), a clinical-stage
biopharmaceutical company focused on developing drugs based on its
proprietary Accordion Pill™ platform technology, today provided an
update on the ACCORDANCE study, the Company's global Phase III
clinical trial of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)
as a treatment for Parkinson's disease (PD) symptoms in advanced PD
patients.
The Company announced that the current pace of recruitment of
patients into the ACCORDANCE study, together with the reduction in
the sample size of the study from 460 patients to 328 patients that
was announced previously, has enabled the Company to reduce the
expected number of clinical sites for the study. To date, 72 sites
have been activated in the U.S., Europe and Israel and the Company expects to complete
enrollment in the ACCORDANCE study in the fourth quarter of
2017.
Intec also reported that patients who have completed the
ACCORDANCE study have continued into the open-label extension
portion of the trial. Enrollment to the open label extension trial
is open only for patients who complete the 25 weeks phase III trial
and are interested in continuing to a 12 month treatment period on
AP-CD/LD.
"We are very pleased with the recruitment rate of the ACCORDANCE
Phase III clinical trial and look forward to our anticipated
completion of enrollment into this important study in the fourth
quarter of 2017," stated Zeev Weiss,
Chief Executive Officer of Intec Pharma. "OFF episodes are
debilitating events for people with Parkinson's disease. We believe
that our AP-CD/LD has a significant potential to make a substantial
difference in the treatment of Parkinson's disease."
About the Accordance Phase III Clinical
Trial
The ACCORDANCE study is a multicenter, randomized, double-blind,
double-dummy, parallel, active-controlled Phase III clinical trial
in the United States, Europe and Israel. The study is expected to enroll
approximately 328 participants across the two original arms:
AP-CD/LD or Sinemet® IR, an immediate-release carbidopa
levodopa medication that is currently on the market. The primary
efficacy endpoint of the study is change from baseline to end of
treatment in the percentage of daily OFF time during waking hours.
Secondary endpoints include safety, daily OFF time (hours), ON time
with and without troublesome dyskinesia (hours), number of daily LD
doses and quality-of-life measurements as evaluated by the
Parkinson's Disease Questionnaires: CG1-1, Parkinson's Disease
Sleep Scale and the Unified Parkinson's Disease Rating Scale
(UPDRS).
The total treatment period for each patient is 25 weeks,
comprised of a six-week, open-label titration on Sinemet IR for all
patients, followed by a six-week open-label titration on two
AP-CD/LD doses (two or three-times daily) and a 13-week
double-blind, double-dummy active comparator period, in which half
of the patients are randomized to Sinemet IR.
All patients completing the ACCORDANCE study are eligible to
enter a 12-month open-label extension study.
Sinemet® is a registered trademark of Merck &
Co., Inc.
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 includes four product candidates in
clinical trial stages: Accordion Pill Carbidopa/Levodopa, or
AP-CDLD, which is being developed for the treatment of Parkinson's
disease symptoms in advanced Parkinson's disease patients;
Accordion Pill Zaleplon, or AP-ZP, which is being developed for the
treatment of insomnia, including sleep induction and the
improvement of sleep maintenance; an Accordion Pill that is being
developed for the prevention and treatment of gastroduodenal and
small bowel Nonsteroidal Anti-Inflammatory Drug (NSAID)-induced
ulcers; and AP-CBD/THC, an Accordion Pill with the two primary
cannabinoids contained in Cannabis sativa, cannabidiol (CBD)
and tetrahydrocannabinol (THC), which is being developed for
various indications including low back pain and Fibromyalgia.
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, including uncertainty
regarding the Company's ability to enroll the required number of
patients therein; 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.
Contacts:
Zeev Weiss
Chief Executive Officer
Intec Pharma
+972-(2)586-4657
zeev@intecpharma.com
Anne Marie Fields
Senior Vice President
LHA
+1-212-838-3777
afields@lhai.com
SOURCE Intec Pharma Ltd