Intec Pharma Presented Phase 1 PK and Safety Data From Accordion Pill Carbidopa/Levodopa at American Academy of Neurology Annual Meeting
JERUSALEM, April 24, 2018 /PRNewswire/ --
Intec Pharma LTD (NASDAQ, TASE:NTEC) ("Intec" or "the Company") today announces that data collected from two Phase 1 studies of its proprietary Accordion Pill Carbidopa/Levodopa (AP-CD/LD) for Parkinson's disease were highlighted in a poster presentation at the American Academy of Neurology 2018 Annual Meeting (AAN 2018) underway in Los Angeles. The poster titled, "Optimizing Delivery of Carbidopa/Levodopa via the Accordion Pill: Comparative PK and Safety From 2 Randomized Crossover Studies in Healthy Volunteers," was delivered by R. Michael Gendreau, M.D., Ph.D. Chief Medical Officer of Intec Pharma, last evening at AAN. The complete poster can be accessed in the Publications section of the Company's website at http://www.intecpharma.com .
The Phase 1 studies evaluated the pharmacokinetics (PK) and safety of AP-CD/LD versus immediate-release (IR) CD/LD (Sinemet®) and under different meal conditions in healthy adults. IN 11 005 was a randomized, two‑way crossover study in which healthy adults received a single dose of AP-CD/LD 50mg/500mg and two consecutive doses of IR-CD/LD 25mg/250mg (0 h and 4 h) following an overnight fast, with a 7-day washout between treatments. IN 14 001 was a randomized, three-way crossover food-effect PK study in which healthy adults received a single dose of AP-CD/LD 50mg/500mg following
high-calorie, low/medium calorie, or fasting conditions. A total of 18 and 30 healthy volunteers were enrolled in IN 11 005 and IN 14 001, respectively.
In study IN 11 005, AP-CD/LD produced more consistent mean LD plasma concentrations overtime, with attenuated peak-trough differences compared with IR-CD/LD, and the mean plasma concentration of CD was similar between IR-CD/LD and AP-CD/LD. Apparent half-life (t1/2) was increased from 1.8 hours with IR-CD/LD to 5.2 hours with AP-CD/LD, while Cmax was decreased from 4,062 ng/mL to 1,951 ng/mL.
In study IN 14 001, LD plasma Cmax concentrations were similar following either a low/medium calorie or high-calorie meal; under fasting conditions, more variability was seen, including significantly shorter retention time versus either fed condition. Likewise, mean CD plasma Cmax concentrations were comparable between the low/medium and high-calorie meals, but significantly greater at nearly all collection times with fasting.
"These data are supportive of our clinical development program for AP-CD/LD and demonstrated that our technology provided more consistent LD plasma levels and less peak‑trough fluctuation when compared to IR‑CD/LD. In addition, these data suggest that AP-CD/LD should be taken with meals, which is consistent with the current dosing regimen in our ongoing Phase 3 clinical trial of AP-CD/LD to treat advanced Parkinson's disease patients," said Dr. Gendreau. "The poster generated considerable interest among neurologists in attendance, which is key to enhancing awareness of our AP-CD/LD as we expect to complete enrollment of the Phase 3 program later this year."
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 being developed 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 indications including low back neuropathic pain and fibromyalgia.
For more information, visit http://www.intecpharma.com.
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Intec Pharma Investor Contact:
Anne Marie Fields
VP-Corporate Communications & Investor Relations
SOURCE Intec Pharma Ltd.