Vitality Biopharma is still one of the top three companies in the cannabis sector positioned to benefit tremendously from the continued passage of legislation legalizing marijuana-based compounds for medical use. Despite a share price that is showing a clear disconnect from competitors like GW Pharma (GWPH) and Arena Pharmaceuticals (ARNA), Vitality Biopharma (VBIO) continues to position itself for substantial growth opportunity in the next several quarters. As VBIO’s studies continue, the company is encouraged by both pre-clinical and case study data which suggest that Vitality Biopharma is well on track to create meaningful THC prodrug treatments for Inflammatory Bowel Disease (IBD) and Narcotic Bowel Syndrome (NBS).
Since 2014, retail investors continue to concentrate on stocks within the cannabis sector that are hoping to create shareholder value through the cultivation and sale of marijuana-based products. However, smart investors stay focused on more realistic value creation opportunities by focusing attention on stocks that are building an impressive intellectual property (IP) portfolio that will serve to protect their market position for the next two decades. Not only is VBIO creating value through the patent approval process, but they are also securing a dominant treatment position in treating severe inflammatory diseases that plague both pediatric and adult patients.
While two other companies, GW Pharma and Arena Pharmaceuticals are also well entrenched into delivering their unique cannabinoid compounds to treat various medical conditions, VBIO’s concentration is more tightly focused on bringing to market specialized cannabinoid products that target inflammatory diseases. Specifically, VBIO’s attention gets centered on treatments that demonstrate tangible and remission inducing responses in a market that is in need of curative treatment, instead of a symptom-only therapeutic drug. Thus, in addressing IBD and NBS specifically, VBIO will benefit not only from the significant barriers to entry for new competitors but will further enjoy product and market exclusivity in treating these diseases for the foreseeable future.
The IBD And NBS Market Is Complicated
To date, current front-line therapies of both IBD and NBS often fail to produce a meaningful or sustained effect for patients. Most treatments are only addressing symptoms, which often include excruciating abdominal pain, infection, bloody diarrhea, and joint pain. Patients with these ailments often receive opiate and steroid treatments, which are ineffective for many, cause severe long-term side effects, and in the case of NBS, actually represent the root cause of the disease, where opioid treatment causes excruciating and persistent abdominal pain
To address these treatment deficiencies, VBIO is developing THC based prodrug treatments to combat both IBD and NBS effectively, targeting the estimated 81% of opiate users with functional bowel disorders, and the over 58% of patients who report chronic abdominal pain. Thus, while the patient population remains starved for a treatment that can induce disease remission, the current standard of care is simply failing for many people with either illness. But, don’t expect big pharma to relinquish its stronghold on treating just the symptoms. The real pressure to create change must come from the patient population, sector advocates, and from companies like VBIO that are demonstrating the value in alternative cannabinoid treatment to curb both symptoms and disease progression.
A strong example of what VBIO may be able to offer patients may get exemplified through clinical study. Vitality Biopharma’s VITA-100 and VITA-210 trials, expected to initiate in 2017, are targeting treatment applications for both IBD and NBS in its separate Phase 1a/1b trials. This first-in-man clinical study of proprietary cannabinoid glycosides (cannabosides) is intended to measure and evaluate the pharmacokinetics and tolerability of cannabosides, and to provide preliminary efficacy data in treating abdominal pain, cramping, and other symptoms associated with each condition. In addition to targeting IBD and NBS, the company’s gut-targeted cannabinoids will also be investigated for the treatment of neuropathic pain, opiate-induced bowel dysfunction, colorectal cancer, and C. difficile indications.
Potential benefits of these low-cost and relatively quick clinical studies, which historically cost less than $2 million and take less than six months to complete, will likely serve as a means to generate both safety data and also proof-of-concept data relevant to several large market gastrointestinal disease indications. Not only is VBIO positioned to advance these trials quickly and cost-effectively, but the internally produced proprietary molecules and use of enzyme biosynthesis processes to create cannabinoid treatments also allow VBIO development independence and the ability to control the pace and conduct of the trial.
Case Study Benefits Pediatric Crohn’s Disease Patient
Being self-sufficient from pre-clinical study to manufacturing processes, VBIO is well positioned to take quick advantage of research results and apply them toward additional medical applications. Within the subset of current IBD and NBS patients, for instance, VBIO published a case study for a pediatric Crohn’s disease patient that produced encouraging results. Data from the study demonstrated success with cannabinoids when all front-line treatments were ineffective. Although preliminary results are promising, VBIO does suggest that additional studies will be required to substantiate its proof-of-concept and therapeutic value in using cannabinoid compounds to treat the disease. But, keeping in mind that additive studies are both quick and inexpensive compared to the alternative drug approval process, the additional studies do not pose a serious drag on potential cannabinoid and THC modeled prodrug approvals.
The recent case study published by VBIO describes a 13-year-old boy with Crohn’s Disease who achieved clinical and biochemical remission after oral administration of cannabinoids. Elements of the case study showed that after years of disease, the patient suffered from a poor appetite, consistent weight loss, incurred stunted growth, and most important from a treatment perspective, failed to achieve remission with conventional therapies, including the markets most promising TNF-alpha inhibitor infliximab.
According to VBIO’s case study presentation, the 13-year-old patient received a formal diagnosis as having Crohn’s disease at the age of 9, whereby mild-to-moderate distal colitis and aphthous ileal ulcerations were acknowledged. During the next four years, the patient was hospitalized on numerous occasions and placed on a treatment that included the use of alpha inhibitors and a morphine drip. After being treated for roughly five years (in five-week intervals) with the most advanced conventional therapies, the patient failed to enter any state of disease remission. Even after introducing additional medicines, including sulfasalazine, Lialda, CANASA, and azathioprine, the patient showed no significant response to treatment. The most aggressive attempt to control the patient’s disease included the introduction of Methotrexate, but caused severe side effects that forced the treating physician to stop the treatment. The only shown benefit the patient experienced was for a brief period when infliximab was the predominant treating compound. However, that result quickly dissipated, and the calproctectin levels in the patient increased to more than 2000 μg/g during the next four months of treatment.
During the four years of disease progression, the patient was unresponsive to conventional therapies, and symptoms continued to worsen causing poor appetite, weight loss, anemia, and continued stunted growth. Additionally, the patient missed 25 days of school per year on average and was hospitalized on a regular basis for Crohn’s symptoms that included intense stomach cramps, anemia, and bloody diarrhea frequency between 10-20 times per day. Inclusive to those debilitating effects, the boy also suffered from five consecutive infections with C. difficile which required hospitalization. Unfortunately, even the most prominent antibacterial medications, including vancomycin were ineffective, leading to the need for treatment with fecal transplants, which ultimately resolved the infection and achieved temporary remission of his IBD. But, the road to a short-lived reprieve was intense and not without extreme cost and patient discomfort. Watching the deterioration and treatment setbacks, his parents decided to seek alternative treatment after learning of the success of Coltyn Turner, a pioneering cannabinoid patient who reported complete clinical remission of similar drug-resistant Crohn’s Disease after using cannabis-based compounds. The results, produced by treatment after all conventional therapies were tried and failed at the Mayo Clinic, demonstrated the value in cannabinoid treatment of the disease for a drug-resistant pediatric patient.
Following the lead from these encouraging results, the VBIO case-study patient received approval for treatment with cannabis under the California Compassionate Use Act, and in mid-February 2016, began cannabinoid therapy with three daily doses of chocolate bar edibles that were each infused with 3mg of THC and 3mg of cannabinoid. Within thirty days, the patient, who had never responded to conventional treatment, had achieved disease remission, and both his calproctectin scores and calproctectin serum levels decreased significantly. After sixty days of cannabinoid therapy, the calproctectin levels decreased to 0mg/L. Of additional significance, the associated serum erythrocyte sedimentation rate declined by 88%, from 25 mm/hr to 3 mm/hr.
Eliminating Infliximab Infusions
The case study also produced additional benefits, including the reduction of infliximab infusions from every five weeks to nine weeks. Despite the objections made by the patient’s attending gastroenterologist, the patient stopped all infliximab treatments during January of 2017, whereby the patient was diagnosed to be in complete remission, with no Crohn’s disease symptoms.Fast forward to the date of publication, and the patient remained in disease remission for more than one-year since starting cannabinoid therapy, gained height and weight, had a healthy appetite, and had not missed a single day of school. Importantly, from a regulatory perspective, the cannabinoid treatment created no adverse reactions or side effects.
Particular to the case study, the results of the cannabinoid therapy prove to be of substantial importance to an illness that avails itself to mostly ineffective treatment options that also fail to deliver measurable long-term results. The study findings are significant to VBIO, whose THC prodrug is specifically aiming to address the symptoms as well as the inflammatory aspects of the disease. Although this is the first documented report of cannabinoid therapy inducing clinical remission in a pediatric IBD patient, the results and outcome presented used objective measures of disease activity and scale rating. Certainly, patient response is more reflective of actual disease progression and symptom relief, but both retrospective and prospective studies of the analysis demonstrate that the use of cannabinoid provided a significant improvement in the quality of life for the patient. No doubt, the results produced serve to reinforce the promise of cannabinoid therapy to provide far more than symptomatic relief.
Vitality Biopharma’s Unique Applications
VBIO’s prodrug technology may alter the landscape of how both IBD and NBS gets treated and is building a platform based off of reliable data that is showing the benefit of cannabinoid treatment. Vitality’s use of glycoside prodrugs, for instance, can selectively target different tissues, including the gut through oral delivery and the brain through intravenous administration. Utilization of the glycoside prodrugs with cannabinoid compounds has already demonstrated reliable targeting to the colon, and data indicates glycoside technology can also enable higher permeation of brain tissue upon intravenous delivery.
Specifically relevant to VBIO’s cannabinoid platform, the glycosylation technology has reliably led to improvements in drug solubility and stability and has set the stage for a novel set of cannaboside compounds. For investors looking for comparison potential, GW Pharma’s more than $2.75 billion market cap lay mostly in its IP portfolio, and the expectations from its IND and NDA drug applications. It’s easy to point out, after all, that with only $3.1 million in most recent quarterly revenues, and a cash burn of almost $34 million, much of GWPH’s market cap is built on the belief that investors have in the blue sky potential of the cannabinoid industry.
VBIO is setting itself up for similar appreciation. The trials that are scheduled to start later this year, coupled with the growing IP portfolio and over 20 submitted patent applications, likely positions the company for an uptick in shareholder value. Similar to GWPH, Vitality Biopharma may quickly take advantage of its clinical data to expedite its therapies and seek FDA approvals through IND, NDA and accelerated approval pathways through 505(b)1 and 505(b)2 filings.
The ultimate promise for VBIO lay in the fact that the company has indeed developed a novel class of cannabinoid compounds that, when used in prodrug form, may lead to potentially revolutionary developments in how inflammatory diseases get treated. By providing a site-specific method of delivery, the VBIO prodrugs can effectually offer local therapeutic benefit, and at the same time eliminate systematic delivery of cannabinoid and THC based drugs into the bloodstream and brain, removing the psychoactive response in users. And, don’t underestimate the value VBIO’s method of delivery, because while competitors may eventually progress toward both pre-clinical and clinical trials, they will be limited to the amount of cannabinoid and THC used due to the psychoactive effects of not using the prodrug technology. That limitation alone establishes significant disadvantages to any potential competitor and fortifies the market leading position that VBIO may enjoy in the IBD and NBS markets.
The Promise For VBIO
From a market perspective, investors should embrace the substantial revenue opportunity at hand, with a current IBD treatment market alone expected to generate more than $9.6 billion in 2017. And, while this aggregate number represents a total treatment market that includes anti-inflammatories, immune-suppressants, and antibiotics, none of the current treatments have demonstrated the ability to cure the disease. VBIO, however, is banking on the compounding data that its treatments will indeed cause substantial and improved patient benefit. Thus, while large pharma and potential competitors may look to control and manage symptoms, VBIO is engaged to in methods intended to place the disease into a long-term state of remission.
For investors, the VBIO prodrug technology offers dual benefit. First, it may provide almost immediate systematic relief in patient symptoms. Second, it may allow for patients to eliminate the need for opioid-based drugs that often lead to misdiagnosis, drug addiction, and additional complications that contribute to the progression of disease symptoms. Now that two key trials are set to begin, VBIO investors are sitting on at least two potential catalyst events for the remainder of the year. Not only are those trials expected to commence soon, but VBIO may also leverage the recent Crohn’s disease case study results to maximize FDA attention to offer expedited pathways for treatment approval. Although VBIO may sometimes get lumped into the micro-cap world of marijuana stocks, the reality exists that VBIO is far from the typical cannabis stock, and is rightfully deserving of a higher market cap than is presently provided. Even with a cursory comparison between GWPH and VBIO, investors can see stark similarities, making the difference in market cap valuation confusing.
In some respects, VBIO’s position in getting treatments to market is similar to GWPH, but at the same time, VBIO will not burn more than $120 million per year to advance its pipeline. What GWPH serves to show investors is that while the big money brokerage houses may make investment bubbles for companies that are yet to prove themselves worthy of multi-billion dollar market caps, they continually ignore investment opportunities that have not relied on their investment roadshows or equity interest to drive exposure. With VBIO trading at less than $2 per share, and with trials set to begin that may elicit expedited FDA review, the better investment opportunity in the small set of cannabinoid developers may lean toward VBIO’s favor, making the stock a worthy consideration for investors.
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