AXIM® Biotechnologies Brings Their Patented CanChew® Plus Delayed-Release CBD Chewing Gum to Clinical Trials for IBS, a $1.5B market opportunity.
AXIM® Biotechnologies announced this week that the company has entered clinical trials for irritable bowel syndrome or IBS with their CanChew® Plus CBD-infused chewing gum. CanChew® Plus is AXIM®’s patented delayed release delivery system for cannabinoids like CBD.
In discussing the clinical trials, Medical Marijuana, Inc. CEO Dr. Stuart Titus stated, “We are thrilled to have a cannabinoid based application that may treat many disorders, including IBS which is now under clinical development. We are certainly excited to announce that we are in such clinical trials and attempting to put the science on top of the anecdotal evidence supporting efficacy in these conditions.”
Research will be completed at the Wageningen University in the Netherlands. The company received approval in December from the Medical Ethical Committee (METC) of Wageningen University, located in The Netherlands, to begin a study on patients suffering from irritable bowel syndrome (IBS) featuring its CanChew® Plus CBD gum.
“We are pleased to have reached another milestone in the development of AXIM products to treat challenging health conditions,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM® Biotech.
Dr. Anastassov continued, “IBS is the most common functional gastrointestinal disorder affecting 9-23% of the worldwide population, and it has no sustainable cure. The clinical trial at Wageningen University is the first of its kind to treat IBS symptoms by cannabinoid-containing chewing gum, and we look forward to sharing updates from the trial with you. With positive outcome from the IBS clinical trial, we are ready to proceed immediately with further trials on our pharmaceutical grade CanChew Rx™ products to treat inflammatory bowel disease (IBD); Ulcerative colitis and Crohn’s disease. We are committed to finding research based cannabinoid solutions to help people suffering from gastrointestinal disorders and other health conditions with no effective remedies.”
The METC at Wageningen University, an institutional approval board that is compliant with the Ethical Principles for Medical Research, is responsible for reviewing and approving applications for clinical studies to be performed at the school. According to the Times Higher Education World University Rankings, Wageningen is the top university in The Netherlands.
Following successful PK/PD trials to test possible effective dosing, AXIM® Biotechnologies will be testing a 50 mg dose of CBD per piece of chewing gum in the Phase II clinical trial.
In discussing the data collected during these PK/PD trials, Dr. Anastassov remarked, “These results show that excellent bioavailability for CBD may be achieved via our proprietary chewing gum delivery system, so that patients suffering from IBS may have symptomatic relief using an easy-to-use solution. We believe that we can match or improve the bioavailability profile for CBD compared to other delivery systems such as smoking or oral intake. We look forward to entering clinical trials and making available our cannabis-based medicinal solutions to patients suffering from IBS and other gastrointestinal disorders as soon as possible.”
The terms of the clinical trial allows patients up to 6 doses of 50 mg a day to control their symptoms of IBS, such as stomach cramps, bloating, and pain. The clinical trial will include 40 patients, aged from 18-65, who have been diagnosed with IBS according to ROME III criteria, which includes abdominal pain that occurs at least three times a month for three months and a change in stool frequency or consistency.
IBS is a chronic condition that requires long-term management. The condition’s impact on a patient’s overall quality of life may be the most significant complication, leading to a demand for effective treatments to ease the suffering of affected patients.
“IBS is a very common and often painful disorder which is still difficult to manage. People often experience sudden flare-ups and for many it has a negative impact on their quality of life. 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” said Renger Witkamp, Professor and Chair in Nutrition and Pharmacology of Wageningen University.
It is unknown what exactly causes IBS. Some experts believe it is linked to issues with communication between the brain and the digestive tract, speeding up or slowing down the movement of stool through the intestine. Symptoms can be triggered by factors like diet, stress, hormonal changes, some medicines, and infections of the digestive tract.
An estimated 15% of the population worldwide suffers from IBS. In developed countries, that number jumps up to 25% of the population, with women under 50 being affected at higher rates than any other group.
It is difficult, however, to determine exact incidence rates since the IBS diagnosis rate is estimated to be less than 50% in major markets. Approximately 40% of all visits to gastroenterologists are due to IBS symptoms.
Currently, IBS affects anywhere between 25 and 45 million people in the United States. Already a significant segment of the healthcare market, the IBS market value in the United States is expected to continue to rise from $589.6 million in 2013 to $1.5 billion by 2023.
The company’s IBS study is just one of several clinical studies AXIM® Biotechnologies is looking to undertake. Earlier in the year, AXIM® announced that it had secured the necessary funding to move forward with a group of cannabinoid-based clinical trials, including trials on its MedChew® RX, CanChew® Plus, and AX-1602 topically applied cannabinoid ointment. The company also published a development pipeline chart to reveal their new drug schedule for the coming months and years.
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