Intec Pharma Ltd., a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill™ platform technology, announces the initiation of a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC), which is being developed by Intec for various indications, including low back pain and Fibromyalgia.
The Cannabis sativa plant is used in 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 promising treatments for painful conditions that do not respond properly to currently available treatments, such as chronic, neuropathic, and inflammatory pain.[1],[2]
AP-CBD/THC holds 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, variability of the administered dose and adverse events that correlate with peak levels. AP-CBD/THC is designed to extend the absorption phase of CBD and THC, resulting-in more consistent levels, for an improved therapeutic effect.
This Phase I trial is a single-center, single-dose, randomized, three-way crossover study to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC, with Buccal Sativex®, in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC[3] . The Company expects to have topline results from this trial in the third quarter of 2017.
“The progression of AP-CBD/THC into the clinic is a significant achievement for Intec and marks a major step forward in developing a potential new therapy for pain management. It is also our first demonstration of the Accordion Pill platform for cannabinoid therapies. Moving forward, we plan to evaluate the Accordion Pill platform in several other indications where a safe, effective, prolonged and consistent cannabinoid therapy may be able to provide therapeutic benefit where other treatments have failed. We are very pleased to have initiated our Phase I trial with AP-CBD/THC,” stated Zeev Weiss, Chief Executive Officer of Intec Pharma.
The cannabis market has significant commercial potential and is projected to represent approximately 10% of the specialty pharmaceutical market over the next five years, or a market of at least $20 billion[4]. According to Global Data, in 2016 the global low back pain drug market was $6.2 Billion and the global Fibromyalgia drug market was $1.8 Billion.
Sativex® is a registered trademark of GW Pharmaceuticals.