Medical Marijuana, Inc. investment company AXIM® Biotechnologies has announced it has completed enrollment of the required 40 patients for its Phase II clinical trial for CanChew Plus® CBD gum for the treatment of irritable bowel syndrome (IBS) and has commenced the start of the research with an anticipated return of the results this spring.
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, 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.”
AXIM®’s Phase II trial will be completed at the Wageningen University in the Netherlands. The company received approval last December from the Medical Ethical Committee (METC) of Wageningen University to begin its study on IBS patients featuring its CanChew® Plus CBD gum. The METC at Wageningen University is an institutional approval board that is compliant with the Ethical Principles for Medical Research responsible for reviewing and approving applications for clinical studies to be performed at the school.
The study is being conducted by Renger Witkamp, Professor and Chair in Nutrition and Pharmacology, at Wageningen University. “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,” said Professor Witkamp. “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.”
Selected from a pool of over 400 patients, the 40 trial patients, aged 18-65, will be subject to a randomized, double-blind, cross-over trial of 8 weeks. All patients in the study 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. Patients will receive a maximum of six pieces of gum per day, either containing 50 mg of cannabidiol per piece, in the case of the CanChew® Plus chewing gum, or a placebo chewing gum. Final data collection for the study is estimated to be complete in April 2017. The full results of the study should be released in June 2017.
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. It is unknown what exactly causes IBS. Some experts believe it is linked to issues with communication between the brain and the digestive tract that results in the speeding up or slowing down of 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.
“We are pleased to have enrolled all patients needed and are fully ready to move ahead with the IBS clinical trial,” said George E. Anastassov, MD, DDS, MBA and CEO of AXIM® Biotechnologies. “CanChew® Plus is underway to be the first cannabinoid treatments with pharmaceutical application for the IBS indication, and we anticipate further trials with our pharmaceutical grade chewing gum products to treat indications such as inflammatory bowel disease, ulcerative colitis and Crohn’s disease.”
The company’s current IBS study is just one of several clinical studies AXIM® Biotechnologies is looking to undertake. Late last 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.
Keep up to date with news from AXIM® Biotechnologies and other Medical Marijuana, Inc. investments by following our news feed.