Financial Press: Robert, could you give us a little bit of a rundown of your company? An elevator pitch, so to speak.
RB: Sure, Vitality Biopharma is an early-stage, drug-development company that’s developed a novel class of cannabinoid pharmaceuticals. Our class of cannabinoid pharmaceuticals are prodrugs that release cannabinoids in a targeted fashion within the GI tract, and they do this in a way that eliminates all drug psycho-activity or intoxication.
FP: Are you talking about CBD? The derivative of cannabis that seems to be taking the nutraceutical markets by storm?
RB: Our compounds are prodrugs of not only CBD, which is not intoxicating, but also THC, which is the principal compound that is psychoactive within cannabis. But we have developed a novel, prodrug technology that enables 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. So, it avoids the intoxication that occurs when THC is delivered into the bloodstream and brain.
FP: That’s very impressive. So, how does your company go about actually targeting the gut and targeting those areas of the body without going throughout the blood system?
RB: Vitality is one of the few groups in the world that has pioneered a process of enzymatic glycosylation. So, we can take any cannabinoid and effectively tack on a glucose moiety or sugar moiety to that compound. And what that enables us to do is create this new class of compounds that are very water soluble and stable and that they can be formulated as oral pharmaceuticals. So you can deliver them just through a simple pill or capsule.
And 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.
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.
FP: Well that sounds fantastic. So, tell me a little bit more about the background and history of Vitality.
I understand your company used to mainly deal with glucose or stevia as a primary target before. Has that sort of led us to the story as to where we are today?
RB: Exactly. So Vitality Biopharma (is a) company that originally was developing a bioprocessing technique to make stevia taste better. And stevia is a high-potency, zero calorie sweetener that’s derived from the stevia plant and the way that product is made within the plant is through this enzymatic glycosylation process.
And a discovery that we made in late 2015 was that this enzyme derived from the stevia plant ended up being a lot more promiscuous and a lot more useful than anyone had ever realized. And so, it not only could modify or glycosylate stevia products, but it could modify cannabinoids, and many other compounds.
It was around late 2015, when we’re one of the only companies that has expertise in bio-synthetic production of these compounds that we discover this stevia enzyme could produce a novel class of cannabinoid glycoside compounds.
FP: So what are some of the main advantages that Vitality has over other companies in the same space?
RB: You know, there are very few companies operating as cannabinoid pharmaceutical companies. A reason for that is that it’s generally very difficult for them to obtain significant IP protection.
That’s because THC and CBD are natural products after all. And nobody owns those compounds. There are companies like GW Pharmaceuticals who has filed and obtained patents on a relatively narrow applications or formulations of cannabinoids. But nobody owns THC or CBD. And so as a result, it’s very difficult for new entrants to enter this market without any significant IP.
You know that 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 that are called cannabosides.
It’s not only that you have something that you own, where you can obtain composition of matter intellectual property on it. 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.
It’s very well established that cannabinoids can have effects on GI conditions including severe autoimmune conditions like Crohn’s disease and ulcerative colitis. 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. So, these patients had failed all FDA-approved treatments. They were not responding to TNF-alpha inhibitors or corticosteroids. And then an eight-week course of treatment with cannabinoids put about half of them into remission.
RB: And so, many patients and patient advocates like parents of kids with pediatric Crohn’s disease; they’re really clamouring for cannabinoids.
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.
FP: What is the size and potential of that Crohn’s disease market?
RB: The Crohn’s disease market is (you know) a large one. And it’s dominated by TNF-alpha inhibitors and it’s about a 10 billion dollar annual market for FDA-approved treatments.
FP: Wow. OK. So any kind of major breakthrough in there is gonna get quite the response from the market. What are some of the next big things that are on deck for Vitality going forward?
RB: So the company over the past year has really been focused on our pre-clinical package that we’re preparing for the FDA and for other regulators around the world to support entry into clinical trials and support the proof-of-concept trials where we intend to demonstrate efficacy based compounds in conditions like inflammatory bowel disease, irritable bowel syndrome, and narcotic bowel syndrome, which is a severe form of opiate-induced abdominal pain. So, next year in 2018, a major focus will be initiation of Phase II trials and obtaining clinical proof-of-concept data with our compounds.
FP: So, to our listeners: If you want to find Vitality Biopharma, you can find them at Vitality dot bio (www.vitality.bio) and their ticker symbol is VBIO and that’s on the OTC, is that correct, Robert?
RB: That’s correct.
FP: Awesome. Thanks again Robert. And we’ll talk to you soon.
RB: My pleasure, thanks a lot.