AXIM Biotech has initiated a Phase 2 clinical trial evaluating the effectiveness of its CanChew Plus cannabinoid (CBD)-based chewing gum for alleviating symptoms of irritable bowel syndrome (IBS).
In the case of positive results, the company will “proceed immediately with further trials on our pharmaceutical grade CanChew Rx products to treat inflammatory bowel disease (IBD), ulcerative colitis and Crohn’s disease,” AXIM CEO George E. Anastassov, MD, said in a press release.
The randomized, double-blind, placebo-controlled Phase 2 clinical trial (NCT03003260) aims to evaluate whether the use of a CBD-containing preparation in the form of CanChew chewing gum (50 mg of CBD per piece of gum) can improve symptoms in 40 adult patients with IBS.
Patients can use up to six pieces of gum a day to control their stomach cramps, bloating, pain, and other IBS symptoms. The primary endpoint of the study is patient-perceived pain reduction. General relief and change in stool frequency will also be evaluated as efficacy measures.
AXIM told IBD News Today that the trial, to be conducted at Wageningen University in the Netherlands, will last 10 weeks, with final data collection indicating primary endpoint measure planned for April 2017. The overall completion date is scheduled for June 2017.
This clinical trial was approved by the Medical Ethical Committee (METC) of Wageningen University.
AXIM recently reported positive results from a single-dose study that evaluated 10 mg and 30 mg doses of CBD in healthy volunteers to determine the concentration of CBD in the blood after chewing one piece of CanChew Plus gum for 30 minutes. In the study, the 30 mg dose showed excellent results. These results were used to determine the optimal concentration of CBD for the current IBS patient trial.
“We are pleased to have reached another milestone in the development of AXIM products to treat challenging health conditions,” Anastassov said. “IBS is the most common functional gastrointestinal disorder, affecting 9 to 15 percent of the worldwide population, and it has no sustainable cure.”
“We are committed to finding research-based cannabinoid solutions to help people suffering from gastrointestinal disorders and other health conditions with no effective remedies,” he added.
Renger Witkamp, professor and chair in nutrition and pharmacology at Wageningen University, said IBS is a common and painful disorder which is difficult to manage.
“People often experience sudden flare-ups and for many it has a negative impact on their quality of life,” he said. “CBD has shown to have promising effects, but there has been a clear need for practical and effective formulations. Providing it via a chewing gum results in sustained release of the compound and better bio-availability.”
CanChew Gum is a patented chewing gum containing naturally occurring cannabidiol from the hemp plant. According to AXIM, CanChew is doctor-recommended with no need for a prescription, and is available in all U.S. states. It is non-habit forming and the natural hemp oil is rich in Omega 3. It contains no artificial sweeteners or preservatives.
AXIM is also evaluating the potential therapeutic properties of its CBD-based products in relieving pain and/or spasticity in patients with multiple sclerosis (MS). More information can be found in Multiple Sclerosis News Today.