This morning, Intec Pharma Ltd. (TASE:NTEC)(NASDAQ:NTEC) announced the results from its phase one clinical trial of AP-CBD/THC, its Accordion Pill containing cannabidiol (CBD) and tetrahydrocannabinol (THC).
Related: Inside Intec Pharma's Accordion Pill Technology
The phase 1 trial tested compared the pharmacokinetics, safety and tolerability of two formulations of Intec's AP-CBD/THC with GW Pharmaceutials' Sativex in 21 healthy volunteers.
The results found that AP-CBD/THC increased exposure of CBD by between 290% and 330% and THC by between 25% and 50% versus Sativex. The median time of peak concentration for AP-CBD/THC was 2 to 3 times longer than Sativex and absorption was significantly higher. AP-CBD/THC was found to be safe and well tolerated.
Additionally, the formation of THC metabolites was meaningfully reduced (>25%) compared to Sativex. This shows that Intec's Accordion Pill technology helped to avoid the "first pass effect". The "first pass effect" describes the phenomenon where the concentration of a drug is significantly reduced (through initial metabolism in the liver) before it reaches the bloodstream.
In conclusion, these results demonstrate that AP-CBD/THC shows significant potential to reduce the drawbacks of cannabinoid treatments that relate to how they are absorbed by the body. These drawbacks include short duration of effect, delayed onset, variability of dose and exposure and adverse events that are correlated to peak levels of cannabinoids in the body.
Related: Intec Pharma Granted Patent in Hong Kong for Accordion Pill
Intec Pharma's Chief Operating Officer, Nadav Navon, Ph.D.
"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®. "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."
Intec Pharma's Chief Executive Officer, Jeffrey A. Meckler
"This study further affirms the value of our Accordion Pill platform as a safe and effective drug delivery platform. 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."
In early trading Thursday, shares of Intec Pharma are falling roughly 1%. We're also watching shares of GW Pharmaceutcals on this announcement given that AP-CBD/THC demonstrated some significant improvements over GW's Sativex in this early-stage trial. In early trading, shares of GWPH are gaining roughly 2%.
Be sure to check out Intec Pharma's marijuana stock profile in order to view a custom stock chart and more recent news from the company. Remember, shares of Intec Pharma can be traded commission-free using the Robinhood app.
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