A new form of cannabinoid prodrugs called “cannabosides”, which were discovered using innovative biosynthesis methods originally developed for improving the taste of stevia, are now set to be recognized around the world, and could revolutionize treatment for serious conditions such as Crohn’s disease.
Currently dominated by TNF-alpha inhibitor treatments, the inflammatory bowel disease (Crohn’s disease and colitis) market is quite large, representing a $10 billion annual market for FDA-approved treatments.
The drugs’ developers, Vitality Biopharma, Inc. (OTC: VBIO), just announced the filing of their cannabosides intellectual property in all major international pharmaceutical markets, through a submission with the Patent Cooperation Treaty (PCT)—unifying the filing process for 151 countries.
Vitality’s filings include “composition of matter” patent claims that cover the company’s THC-based prodrugs, including their current flagship candidate VBX-100, a gut-targeted cannabinoid pharmaceutical.
“We are excited to initiate patent prosecution in the U.S. and global pharmaceutical markets, where we are seeking broad patent coverage for VBX-100 and the entire portfolio of cannabosides,” said Dr. Brandon Zipp, Director of R&D, and Scientific Co-founder of Vitality Biopharma in the company’s press release.
MOVING FORWARD WITH THE PATENTS
Once granted, the coverage of the underlying patent claims for cannabosides would extend at least until 2035, and could enable protection of Vitality’s intellectual property in all major pharmaceutical markets worldwide.
The company has already moved forward with its submissions for patent applications in the USA, Europe, Japan, and other additional key regions.
VBX-100 AND CANNABOSIDES: NON-INTOXICATING TREATMENT
VBX-100 and the cannaboside prodrug technology enables large concentrations of cannabinoids to be selectively delivered to the intestinal tract with limited entry into the bloodstream or brain—virtually eliminating all drug psycho-activity or intoxication.
Comprised not only of CBD, which is not intoxicating, but also with THC, which is the principal compound that is psychoactive within cannabis, Vitality Biopharma has truly developed a novel prodrug technology. Cannaboside technology enables the targeting of THC, CBD, and other cannabinoids to the colon, where it can be restricted to that region, provide local relief of pain and inflammation, and avoid systemic delivery.
The proposed safety of the cannabosides drug portfolio presents a healthy benefit for Vitality and for patients—especially for parents of pediatric patients, looking to ensure that their children are relieved of symptoms, without the intoxicating effects attributed to THC and other cannabinoids. The promise of these prodrugs is heightened quality-of-life for patients, and more novel cannabinoid drug formulations from Vitality using the same approach.
Vitality Biopharma CEO, Robert Brooke, said in the latest press release: “Today, Vitality is positioned very well for growth, as we have a highly differentiated and proprietary set of compounds that could dramatically alter the quality-of-life for patients.”
HISTORY OF CANNABOSIDES
Originally, Brooke’s company was developing a bioprocessing technique to improve the taste of the natural, high-potency, zero-calorie sweetener called stevia.
Vitality was targeting the way the stevia plant was processed, through the enzymatic glycosylation process.
Through a discovery made in late 2015, Vitality found that an enzyme derived from the stevia plant ended up being a lot more useful than anyone had ever realized—Not only could the company now modify or glycosylate stevia products, but they could also modify cannabinoids, and many other compounds. As one of the only companies that had expertise in bio-synthetic production of these compounds, Vitality’s brain trust discovered they could produce a novel class of cannabinoid glycoside compounds, which eventually became the cannabosides IP that is now in the process of patenting.
Where the company has an advantage, is its ability to overcome the very difficult process of obtaining significant IP protection for cannabinoids—which because THC and CBD are natural products, typically no company can own those compounds. So by developing a novel prodrug using its proprietary stevia biosynthesis methods, Vitality has positioned itself to achieve what many other companies could not.
“IP is really at the core of any successful drug development or biotech company. And so we were very fortunate in late 2015, that we discovered this novel class of cannabinoid prodrugs,” said Robert Brooke.
Moving forward, the company will look to apply their composition of matter IP towards GI tract conditions, including severe autoimmune conditions like Crohn’s disease and ulcerative colitis.
Robert Brooke added: “There have already been independent clinical trials that showed that just an eight-week course of treatment with cannabinoids was able to induce remission in almost half of Crohn’s disease patients that were drug-resistant. What we’re doing is enabling them to use those through gut-restricted compounds that avoid psychoactivity. That way you can avoid any of the issues or remove the principal obstacle that you have when pediatric gastroenterologists are asked about cannabinoids.”
The company expects its major focus in 2018 to be the initiation of Phase II trials, and obtaining clinical proof-of-concept data with its compounds.
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