(FinancialPress.com) / November 7, 2017 / Improvements upon previously established pharmaceutical treatments is often a way that a junior pharma company can get itself onto the map. For California-based Vitality Biopharma (OTC: VBIO), strategy is to seek a foothold in the prodrug market.
Already with DEA approval to develop pharmaceutical cannabinoids (including extracts from highly regulated cannabis plants), Vitality is ahead of many of its peers, with multiple flagship worthy cannabinoid drug candidates on deck, and a proprietary production process developed from its past life researching stevia.
And it’s through that relationship with stevia that Vitality believes it can unlock the true healing power of cannabinoids—in the form of gut- and brain-targeting prodrugs.
WHAT ARE PRODRUGS?
Prodrugs are an effective way to snap up a significant market share, is through the development of prodrugs—medications or compounds that are converted within the body into a pharmacologically active drug.
So when a 1.0 version of a drug is approved by the FDA or other regulatory body, it’s easier and more economic for a junior company to take the ball and run with it, by improving the drug’s targeting ability, and reducing side effects.
Thus, by developing a prodrug, a company can bypass side effects by optimizing the drug’s delivery, often times by modifying the compound to better target the affected area.
The result has been a boom of prodrugs on the market since 2015, as there have been approximately 15 prodrugs classified as blockbusters in that time—each one having achieved annual sales in excess of $1 billion.
SUGAR-COATING A CURE
When Vitality Biopharma was originally developing a bioprocessing technique designed to make the high-potency, zero-calorie sweetener stevia taste better, they made what would be a company-changing discovery.
Through the use of a proprietary enzymatic glycosylation process, Vitality was able to successfully isolate an important stevia-based enzyme that was a lot more promiscuous, and therefore a more useful catalyst than its developers initially realized.
The result was a piece of the puzzle that let Vitality modify cannabinoids (and many other compounds), essentially sugar-coating them to enable a targeted delivery method for the medicine.
“It was around late 2015, when we were one of the only companies with this expertise in bio-synthetic production of these compounds when we discovered that this stevia enzyme could produce a novel class of cannabinoid glycoside compounds,” says Robert Brooke, CEO of Vitality Biopharma.
AN INTELLECTUAL PROPERTY ADVANTAGE
The two main cannabinoids with notable medicinal attributes are known best by their three-letter abbreviations: THC and CBD.
But since cannabinoids in their basic form cannot be patented, no company can own the exclusive rights to these compounds. While some patent seekers are trying to nail down certain strains or delivery methods, from a pharmaceutical standpoint THC and CBD are going to remain like that of open source software.
However, when Vitality went on to develop from their stevia-based enzyme the company’s main flagship IP, called cannabosides, they created an entirely new class of compounds that is indeed available for patent protection.
Companies such as GW Pharmaceuticals (OTC: GWPH) have already successfully filed and obtained patents on relatively narrow applications or formulations of cannabinoids. But nobody owns THC nor CBD, and as a result, it’s very difficult for new entrants to enter this market without any significant IP.
“We were very fortunate in late 2015 to discover this novel class of cannabinoid prodrugs,” says Brooke.
“Having cannabosides as our IP has been very advantageous for a company of our size, and at our stage. When it comes to IP, it’s not only that you have something that you own and that you can obtain composition of matter intellectual property on—But it’s also important for that product to do something that’s really differentiated or distinguished within the market and that’s really in high demand.”
GUT-TARGETING TO GREATNESS
Where these cannabosides will first be unleashed upon is in the gut, as a method of relieving painful symptoms from gastrointestinal conditions such as Crohn’s disease, and ulcerative colitis.
The Crohn’s Disease market alone is quite large, currently dominated by TNF-alpha inhibitors, representing an estimated $10 billion dollar market annually for FDA-approved treatments.
There have already been independent clinical trials showing 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.
When these patients had failed all FDA-approved treatments—meaning they weren’t responding to TNF-alpha inhibitors or corticosteroids—it was through an eight-week course of treatment with cannabinoids that put nearly half of the patients into remission.
A truly remarkable success result.
By attaching glucose-like compounds to the cannabinoids, Vitality is able to better bypass any of the psychoactive side effects associated with THC, and deliver medicine directly to the inner linings of the intestines that have been inflamed.
“The glycosylation process enables us to take a cannabinoid after it’s been formulated within a capsule and it transits all the way through the GI tract to the colon or large intestine and that’s where your gut microbes secrete enzymes that cleave off the sugar,” says Brooke.
“They want to grab that sugar as energy or fuel, and then they release the cannabinoids. That’s where compounds like THC can coat and cool the intestines, providing relief of pain and inflammation and do it without entry into the bloodstream or brain.”
Over the past year, Vitality has been focused on its pre-clinical package they’re preparing for the FDA, and for all other relevant regulators around the world.
The aim is to support entry into clinical trials, and to support the required proof-of-concept trials, with the intent to demonstrate efficacy based compounds in conditions such as: Crohn’s; inflammatory bowel disease; irritable bowel syndrome; and narcotic bowel syndrome (a severe form of opiate-induced abdominal pain).
Going into 2018, the company’s major focus will be on the initiation of Phase II trials, and obtaining clinical proof of concept data with their compounds.