ISRAEL: Intec Pharma, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the results from a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform with cannabidiol (CBD) and tetrahydrocannabinol (THC), the two primary cannabinoids contained in Cannabis sativa.
“We’re excited about these encouraging results from our Phase 1 study of AP-CBD/THC as it shows the Accordion Pill platform is well suited to safely deliver CBD and THC with significant improvements in exposure compared with Sativex,” said Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma. “We are particularly pleased to see the reduction in THC metabolite, which tells us that the AP-CBD/THC avoided some of the hepatic first-pass metabolism of THC.”
The Phase I trial was 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 Sativex in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC.
The study results showed that AP-CBD/THC had significant improvements in exposure of CBD (290% – 330%) and THC (25% – 50%) compared with Sativex. The median time of peak concentration was 2-3 times longer than Sativex and absorption was significantly higher. Importantly, the formation of THC metabolites were meaningfully reduced (>25%) and AP-CBD/THC was found to be safe and well tolerated with no serious adverse events reported.
“This study further affirms the value of our Accordion Pill platform as a safe and effective drug delivery platform,” said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma. “We plan to review these data in the coming weeks to determine the next steps in developing our AP-CBD/THC program and plan to announce the next steps in the clinical development of this exciting program by year end.”
The Cannabis sativa plant is 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 properly to currently available treatments, such as chronic, neuropathic and inflammatory pain,.
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.
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. 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.