Intec Pharma Advances Medical Cannabinoid Development Program With Dosing of First Patient in a Phase 1 Pharmacokinetic Study of Accordion Pill-THC
The Phase 1 PK study is a single-center, single-dose, randomized, open-label three-way crossover study to investigate the PK, safety and tolerability of AP-THC in up to 18 normal healthy volunteers.
"We are very pleased to be advancing our medical cannabinoid development program as we believe the Accordion Pill's gastric retentive technology is ideally suited to extend the absorption phase of THC, with the goal of a slower rate of rise and more consistent drug plasma levels after oral delivery. The combination of the slower rate of rise with sustained and consistent plasma levels is expected to lead to an improved therapeutic effect and reduce the adverse events that are correlated with rate of rise and peak THC plasma levels," said
"Following this PK study, we plan to initiate a PK study of AP-cannabidiol (CBD) in the first half of 2019. Both our THC and CBD programs utilize pharmaceutically-pure synthetic cannabinoids as starting materials. This allows us to provide a pure and reproducible drug delivery profile with the AP platform that we believe fits under existing regulatory approval mechanisms. We continue to be enthusiastic about the potential for this program, especially as the
The Accordion Pill has the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variable potency batch to batch, variability of the administered dose and adverse events that correlate with rate of rise and peak levels.
An earlier Phase I trial of the Accordion pill formulated with plant derived THC and CBD together in a 1:1 ratio (AP-CBD/THC) compared the PK, safety and tolerability of two different AP formulations of AP-CBD/THC with Sativex® in 21 normal healthy volunteers. The results showed that patients in the AP- CBD/THC arm demonstrated significant improvements in the bioavailability of CBD (290% - 330%) and THC (25% - 50%) when compared with Sativex sublingual spray. The median time to reach peak THC concentration was 2-3 times longer with AP-CBD/THC as compared to Sativex. Importantly, the formation of THC metabolites was meaningfully reduced (>25%) and AP-CBD/THC was well tolerated with no serious adverse events reported.
The Cannabis plant has traditionally been used for the treatment of chronic pain and a variety of other indications. Previous clinical studies conducted using the whole plant or specific extracts generated evidence of the cannabis analgesic activity. Furthermore, extracts containing known amounts of the active plant driven compounds (mainly THC and CBD) or diverse synthetic THC derivatives are thought to be promising treatments for painful conditions that do not respond well to currently available treatments, such as chronic, neuropathic and inflammatory pain.,
Sativex® is a registered trademark of
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.
For more information, visit www.intecpharma.com. We routinely post information that may be important to investors in the Investor Relations section of our website.
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 Boehnke KF, Litinas E, Clauw DJ, Medical Cannabis Use Is Associated With Decreased Opiate Medication Use in a
 Kevin P. Hill,
Intec Pharma Investor Contact:
Anne Marie Fields
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