Israeli-based biopharmaceutical firm Intec Pharma has begun a Phase I clinical trial of AP-CBD / THC for the treatment of multiple indications such as low back pain and fibromyalgia.
AP-CBD / THC is the firm's Accordion Pill platform, containing two primary cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC) derived from the Cannabis sativa plant.
Used for the treatment of indications such as chronic pain, the plant's previous clinical trials provided evidence for its analgesic activity.
The single-centre, single-dose, randomised, three-way crossover Phase I trial will evaluate the pharmacokinetics, safety and tolerability of two formulations of AP-CBD / THC compared to Buccal Sativex in 21 healthy subjects.
Sativex is a commercially available oral buccal spray made up of CBD and THC.
Intec Pharma chief executive officer Zeev Weiss said: "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."
AP-CBD / THC is reported to possess the potential to address major drawbacks such as short-effect duration, delayed onset, variability of exposure and the administered dose, and adverse events of the existing treatments.
It is expected that the top-line results from the trial will be reported in the third quarter of this year.
Image: THC-filled trichomes on a Cannabis sativa leaf. Photo: courtesy of Indirectantagonist/Wikipedia.