JERUSALEM, June 25, 2019 /PRNewswire/ --- Intec
Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today
announces that results from an earlier Phase 2 clinical study of
the Accordion Pill®-Carbidopa/Levodopa (AP-CD/LD) in
Parkinson's disease (PD) patients were published in the
peer-reviewed journal, Parkinsonism and Related
Disorders. The article titled, "Pharmacokinetics and
efficacy of a novel formulation of carbidopa-levodopa (Accordion
Pill®) in Parkinson's disease" is now available online
as an e-publication ahead of print. The article can be
accessed here.
The article reviews pharmacokinetic and efficacy data from the
Company's phase 2, multicenter, open-label, two-way randomized
crossover study that evaluated multiple dose strengths of the
AP-CD/LD (50/250 mg, 50/375 mg or 50/500 mg) twice daily in one
treatment period and an active comparator in the other treatment
period. The article presents results from cohorts 1-4 out of
the 6 cohorts of PD patients who participated in the study.
Pharmacokinetics (PK) and efficacy were evaluated for
AP-CD/LD compared with immediate release Carbidopa/Levodopa
(IR-CD/LD). Treatment-emergent adverse events (TEAEs) and patient-
and investigator-reported measures were also evaluated.
The PK results showed that compared with IR-CD/LD, treatment
with either AP-CD/LD dose demonstrated more stable LD plasma
concentrations in both fluctuating and non-fluctuating PD patients,
and significantly decreased the LD Cmax (57.1% and 66.8%
decreases among fluctuating and non-fluctuating patients,
respectively).
According to the study's authors, "Overall, the PK profile of
AP-CD/LD 50/375 is similar to the PK of intestinal CD/LD infusion
and better than PK parameters reported for other orally
administered LD products developed for extended dopaminergic
effect."[1] [2]
Treatment with either AP-CD/LD 50/375 dosed twice per day
(Cohort 3) or AP-CD/LD 50/500 dosed twice per day (Cohort 4)
significantly improved motor fluctuations compared with
participants' current treatment. Cohort 3 significantly reduced
mean daily OFF time by 44% (p< 0.001) and Cohort 4 significantly
reduced mean daily OFF time by 45% (p< 0.001) compared with
IR-CD/LD. In Cohorts 3 and 4, total ON time (ON state without
dyskinesia), good ON time (ON state or ON with non-troublesome
dyskinesia), the proportion of total ON time during waking hours,
and the proportion of good ON time during waking hours
significantly increased with both AP-CD/LD 50/375 and
AP-CD/LD 50/500, while both bad times (OFF state and/or ON with
troublesome dyskinesia) significantly decreased with both AP doses
compared with IR-CD/LD.
The results also showed that treatment with either AP-CD/LD
50/375 (Cohort 3) or AP-CD/LD 50/500 (Cohort 4) significantly
improved both patient and investigator ratings on the Global
Clinical Impression compared with current treatment (p<
0.01).
TEAEs 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 study.
"In addition to more consistent LD plasma concentrations with
AP-CD/LD regardless of whether patients were experiencing motor
fluctuations, this new delivery platform resulted in decreased OFF
time compared with the IR form. Given the high correlation of
clinical effect with LD pharmacokinetics, the efficacy of the
AP-CD/LD 50/500 dose in Cohort 4 was not unexpected," concluded
study author, Peter A. LeWitt, M.D.,
Departments of Neurology, Henry Ford Hospital and Wayne State University School of Medicine in
Bloomington, Michigan.
"Importantly, the substantially improved ON time for the AP versus
IR was attained without an emergence of troublesome
dyskinesia."
"The valuable information gathered in this pilot study has
informed and guided the further development of the AP for PD in an
ongoing phase 3 multicenter, randomized, placebo-controlled study.
In the phase 3 study, both 2x and 3x per day regimens of AP-50/400
and AP-50/500 mg doses are being tested. As these doses are the
same or similar to those used in the pilot study reported here,
similar stable LD and CD plasma levels within the therapeutic range
necessary for PD symptom control are expected from the phase 3
study," added Dr. LeWitt, who is also the Principal Investigator of
the global Phase 3 ACCORDANCE clinical study evaluating the AP in
PD patients.
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.
[1] P.A. LeWitt, D. Jennings,
K.E. Lyons, R. Pahwa, A.L.
Rabinowicz, J. Wang, et al., Pharmacokinetic-pharmacodynamic
crossover comparison of two levodopa extension strategies, Mov.
Disord. 24 (9) (2009) 1319–1324.
[2] H.M. Yao, A. Hsu, S. Gupta, N.B. Modi, Clinical
pharmacokinetics of IPX066: evaluation of dose proportionality and
effect of food in healthy volunteers, Clin. Neuropharmacol. 39 (1)
(2016) 10–17.
Intec Pharma Investor Contact:
Anne Marie
Fields
VP-Corporate Communications & Investor Relations
646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.