AXIM® Biotech Advances IBS Program After Successful Dosing Study
January 5, 2017 12:42 pm ET
AXIM® Biotechnologies Inc. (OTCQB: AXIM), a leader in cannabinoid research and development, recently announced the successful completion of a pharmacokinetic (PK) study of its CanChew Plus® CBD Gum. The single-dose study on 10 mg and 30 mg concentrations of cannabidiol (CBD) measured blood concentrations after chewing a single piece of gum for 30 minutes. The 30 mg dosage showed excellent bioavailability and will be used in the upcoming AX-1601 clinical trial.
“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 via an easy-to-use solution,” said AXIM® Biotech CEO George E. Anastassov, MD, DDS, MBA. “We believe that we can match or improve the bioavailability profile for CBD compared to other delivery systems such as smoking or oral intake.”
The company will use the dosing data to determine the most optimal dosing for patients involved in its clinical trial, which will evaluate the safety and efficacy of CBD in treating the symptoms of IBS. In pre-clinical studies, CBD has been shown to modulate inflammation by interacting at extra-cannabinoid system receptor sites, such as peroxisome proliferator-activated receptor-gamma and other important targets.
According to Global Data, a research and consulting firm, the global therapeutics market for IBS is set to grow at a 9.9% annual rate from $589.6 million in 2013 to $1.5 billion by 2023. Allergan plc’s (NYSE: AGN) Linzess is expected to contribute the highest revenue at $307.2 million by 2023, as a second-line treatment in patients suffering from constipation-predominant IBS (IBS-C), although there’s growing competition from companies like Abbott Laboratories (NYSE: ABT).
AXIM® Biotech appears to be the only company pursuing clinical trials that evaluate CBD for the treatment of IBS. If pre-clinical data translates to clinical results, the company could become a significant player in a billion-dollar market over the coming years. The company intends to move into Phase IIA and Phase III clinical studies this year and file a New Drug Application (NDA) by 2019, with the potential for partnerships in the interim.
The company’s upcoming Phase IIA clinical trial will give participants a maximum of six chewing gums per day that contain either 50 mg of CBD per chewing gum or placebo over a three-week period. After that time, the participants will undergo a one-week wash-out and then switch intervention to either placebo or CanChew® for another three weeks. The main endpoint is a change in pain reduction perception experienced using VAS-scale.
In addition to its IBS clinical trial, the company has developed a robust clinical pipeline consisting of nine upcoming clinical programs as well as development of five nutraceutical products. As clinical data is generated, the company could also partner with third parties to advance clinical trials into Phase III and NDA approvals.
Investors interested in the cannabinoid space may want to take a closer look at AXIM® Biotech (OTCQB: AXIM) given its unique chewing gum-based delivery system, robust clinical pipeline, and near-term catalysts from clinical studies.
For more information, visit the company’s website at www.aximbiotech.com.