According to the CDC, Inflammatory Bowel Disease (IBD) is a broad term that describes conditions characterized by chronic inflammation of the gastrointestinal (GI) tract. Inflammatory bowel diseases cause long term chronic, as well as severe, inflammation in the GI Tract without any known cause. The two most common forms of IBD are ulcerative colitis (UC) and Crohn’s disease. Both illnesses are caused by an abnormal response to the body’s immune system.
An estimated 3.1 million people (1.3% of entire population) in the US were diagnosed either with Crohn’s disease or Ulcerative Colitis in 2015. It is projected that 70,000 new cases of IBD are diagnosed in the US each year. Canada has the highest IBD prevalence in the world. This rising incidence of IBD is fueling demand in North America for viable treatments.
The Global IBD drug market is predicted to rise from $8.5 billion in 2016 to $9.5 billion by 2020. Biologic therapies held 57% share of the IBD market in 2017.
There is no permanent cure and current treatments only relieve the symptoms of these diseases. The goal of inflammatory bowel disease treatment is to reduce the inflammation that triggers the sufferer’s signs and symptoms.
Often times the best case scenario is symptom relief. Current treatments include Anti-Inflammatory drugs, Immune system suppressors, Antibiotics, and Surgery. Up to one-half of people with Crohn’s disease will require at least one surgery, in which a large portion of your digestive tract will be removed. Even then, the benefits are only temporary as the disease often reoccurs.
Perhaps the Biotech companies and FDA aren’t looking in the right spot. Many feel the drug companies want us to stay sick so they can keep profiting. Imagine there was a natural solution to these dreaded diseases. Picture a world where one compound could treat this and multiple diseases with minimal side effects. Wouldn’t that be amazing?
With its unique products in the pipeline and novel class of cannabinoid glycoside prodrugs – Vitality Biopharma, Inc. (OTC: VBIO)– is in a highly attractive spot to become a leader in this industry.
Vitality Biopharma focuses on the development of cannabinoids for the treatment of neurological and inflammatory disorders, such as inflammatory bowel disease and multiple sclerosis in the United States. The company is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders.
- The pharmacology of cannabinoids provides significant potential for therapeutics across several diseases that form the core of specialty pharmaceutical drugs.
- Cannabinoid-based pharmaceuticals will emerge as part of the $60 Billion market for pain management in part by displacement of opioid painkillers. By 2024, the market for pain management therapeutics is projected to grow to $83.0 billion.
- Cannabinoids are a class of more than 60 molecules found within Cannabis sativa, and they are the active ingredients in medical marijuana.
- Due to federal restrictions, there traditionally has been a lack of pharmaceutical research dedicated to exploring their medical claims, which has led some to describe cannabinoid research as ‘a neglected pharmacological treasure trove’.
- Cannabis exerts pleiotropic (producing more than one influence; exhibiting multiple expressions) effects on the brain, and medical marijuana has been prescribed for applications ranging from chronic pain, nausea/vomiting, severe anorexia, and muscle spasticity.
- Clinical studies have evaluated effects on chronic pain, neuropathic pain, multiple sclerosis, and many other neurological disorders, with success.
VBIO’s mission is to improve the lives of patients afflicted with devastating neurological and inflammatory conditions, such as inflammatory bowel disease. They have developed a new class of cannabinoid prodrugs, known as cannabosides.Cannabosides are cannabinoids that have been glycosylated (bound to glucose) via proprietary enzymatic biosynthesis methods.
Products in the pipeline include VBX-100 for gastrointestinal disorders, including inflammatory bowel disease, irritable bowel syndrome, and narcotic bowel syndrome, a severe form of opiate-induced abdominal pain; VBX-210 is for treatment of chronic conditionsand additional cannabinoid formulations are being developed for treatment of refractory pain and autism spectrum disorder.
VBIO believes that its prodrug VBX-100 could enable targeted delivery of THC molecules into the gut, which would enable higher local concentrations for pain and inflammation in the gastrointestinal tract. The company plans to begin Phase 1 studies this year in order to pave the way for shorter Phase 2 trials that use acute dosing regimens.
Simply put, prodrugs are medications or compounds that are converted within the body into a pharmacologically active drug and exert the same beneficial therapeutic reactions without the side-effects. Prodrugs overcome well-known drawbacks of current therapies. Vitality’s prodrug technology enables targeted delivery to the GI tract, harnessing the therapeutic effects of THC locally while avoiding psychoactivity. Colon-targeting also avoids the adverse systemic effects of immunosuppressive IBD therapies (such as TNF-alpha inhibitors, corticosteroids, etc.)
Because the reference drug already has independent verification of its safety and efficacy, the prodrug may be approved rapidly through demonstrating similar bioavailability or bioequivalence, and at the same time a prodrug can be far more marketable due to its ability to eliminate unwanted side effects or undesirable commercial aspects.
There is one prodrug you’ve been using your entire life: ASPIRIN.
Aspirin, also known as acetylsalicylic acid, was first made by Felix Hoffmann at Bayer in 1897 and is a synthetic prodrug of salicylic acid.
As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having achievedannual sales in excess of $1 billion.
VBIO has intellectual property covering more than 20 cannabinoid prodrugs including modifications of non-psychotropic THC (VBX-100), CBD, and CBDV, a new class of cannabinoid pharmaceuticals known as cannabosides.
Vitality Biopharma’s VBX-100 is a non-psychotropic derivative of THC, which has demonstrated therapeutic effects for inflammatory bowel disease (Crohn’s disease and colitis) in preclinical tests, and THC has independently been tested already in clinical trials with patients where all currently FDA-approved medications were ineffective.
“Our team first pioneered a novel biosynthesis process for our cannabinoid prodrugs, and now they’ve successfully scaled it in a way that could enable widespread supply for clinical trials and even commercialization. This puts us in an enviable position within our industry, and we look forward to seeing what else can be achieved in the months and year ahead.”
~Robert Brooke, CEO and Co-founder of Vitality Biopharma
See for yourself!
VBX-100 has been proven to limit THC’s psychoactivity with targeted delivery. When ingested orally, the THC prodrug moves through the digestive tract before decoupling to release the THC STRICTLY within the intestines. Since the THC is not absorbed, there is no entry of THC into the bloodstream and brain. This opens the pathway for multiple uses of the delivery mechanism, and may enable widespread use of THC in sensitive populations including pediatric and elderly.
THC has been approved as a pharmaceutical in the U.S. for over 30 years.In pill form, it’s known as MarinolTM or dronabinol. Because of this, there is a tremendous amount of safety data already available on file at the FDA. There is also independent clinical trial data showing preliminary signs of THC’s effectiveness.
Independent clinical trial results suggest that cannabinoids will help induce remission in Crohn’s disease patients, even in severe patients where all conventional therapies have been ineffective.
The vast majority of inflammatory bowel disease patients using cannabinoids also experience symptomatic relief, including more than 75% of patients who have reported improvement in visceral pain and abdominal cramping in an independent study.
VBIO blew everyone away recently with approval from the U.S. Drug Enforcement Administration (DEA) and the State of California Research Advisory Panel permitting the Company to continue development of its novel cannabinoid pharmaceutical prodrugs. This comes on the heels of explosive news that they discovered new antimicrobial activity of cannabinoids and its application for treatment of C. difficile-associated diarrhea and colitis.
The CDC estimates there are more than 2 million illnesses annually due to antibiotic resistance. Many of these severe infections are hospital-acquired and now known to be attributed to C. difficile, a pathogen that colonizes the gastrointestinal tract. C. difficile infections cause diarrhea and colitis and contributed to 29,000 deaths in the U.S. in 2015, primarily in sensitive elderly populations.
Recent studies show that cannabinoids may be useful for both addressing the inflammatory state of the colon, as well as confronting the microbial dysbiosis at the root of the problem. This represents a new possible mechanism for cannabinoids, yet is very much in-line with the current scientific understanding that cannabinoids play a prominent role in promoting intestinal homeostasis and long-term healing.
VBIO’s VBX-100 is also showing promise as a treatment of Narcotic Bowel Syndrome, a severe form of opiate-induced abdominal pain. Opiate-induced abdominal pain is often misdiagnosed today, which can lead escalating dosages of opiate painkillers and severe drug dependence.
Cannabinoids could reduce peripheral neuroinflammation within the spinal cord and enteric nervous system.
The Bottom Line
VBIO has a number of things going for it. In addition to everything we’ve read, Vitality is one of a few companies that has obtained DEA approval to develop cannabinoid pharmaceuticals within the U.S. This allows the company to operate with stability for many years to come. Emerging data is showing how powerful cannabinoids could be as an alternative to opioids, with potential to help millions of American safely wean or taper off the use of narcotic painkillers. By being proactive with the FDA, VBIO can gain expedited FDA approval through entry into its Breakthrough Therapy, Fast Track, or Accelerated Approval programs.
By comparison, the cannabinoid drug Sativex from GW Pharmaceuticals (GWPH) and Marinol from AbbVie (ABBV) cannot prevent the side effects of these types of therapies. Vitality Biopharma’s (VBIO) drugs do. It stands to note that while GWPH (approx. $4.0 Billion Market Cap) and ABBV ($143 Billion Market Cap) have already experienced historic runs, VBIO still remains relatively unnoticed with a market cap still under $50.0 Million.
Another reason to consider VBIO: Vitality isn’t trying to reinvent the wheel.
The industry is already proving cannabis-based therapeutics can be effective, particularly for inflammatory bowel disease, muscle spasticity in multiple sclerosis, neuropathic pain, and control of seizures. VBIO is simply building on proven research with an even better version of existing therapeutic approaches. That reality lowers the risk of an investment by upping the odds of success.
If VBIO can penetrate even a fraction of these markets, we will see some monster numbers come out – especially when compared to the miniscule market cap of the company.
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