Vitality Biopharma Applies for Orphan Drug Status

Vitality Biopharma, Inc. (OTCQB: VBIO) announced it submitted an orphan drug designation request for VITA-100 to the U.S. Food & Drug Administration (FDA).

Vitality hopes to gain VITA-100’s approval as an orphan drug for the treatment of pediatric ulcerative colitis (UC), a form of pediatric inflammatory bowel disease. The U.S. Orphan Drug Act (ODA) of January 1983 is meant to encourage the development of drugs for rare diseases. Review by the FDA’s Office of Orphan Products Development can expedite the evaluation and eventual market approval of products that demonstrate significant promise for the treatment of these conditions. Orphan Drug status offers additional incentives, including tax credits for clinical testing, seven years of market exclusivity, fast-tracking for regulatory proceedings, and exemption from prescription drug user fees.

Vitality Biopharma’s gut-targeted cannabosides enable delivery of THC without psychoactivity or intoxication. The delivery system creates the potential for widespread use of cannabinoids to treat pediatric digestive disorders. The Company has already completed studies that demonstrate the efficacy of cannabosides for treating preclinical models of colitis. Cannabosides were able to improve gastrointestinal health, reduce weight loss, decrease damage to the colon compared to the placebo controls.

“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” said Robert Brooke, CEO and Co-Founder of Vitality Biopharma. “Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries.”

What Is a Pro-Drug

Pro-drugs are compounds which, after ingesting, convert within the body into a pharmacologically active drug. A pro-drug based on a drug that already has FDA approval may be approved rapidly through demonstrating similar therapeutic.  Aspirin, acetylsalicylic acid, first made by Felix Hoffmann at Bayer in 1897 is a synthetic pro-drug of salicylic acid. 

The pro-drug is often highly marketable as it can reduce undesirable side effects.  VITA-100’s targeted delivery could deliver therapeutic benefits while eliminating delivery of THC to the bloodstream.  Estimates are that 15 pro-drugs in development are blockbusters with potential annual sales of more than $1 billion.

Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) is another company developing pro-drugs. Its ZYN001 is a patch to deliver a time-release synthetic THC. The delivery systems are different but, Zynerba and Vitality help prove each others concept.

Vitality has filed intellectual property applications and is seeking worldwide patent protection through 2035 with strong composition of matter claims for pro-drugs of CBDV, CBD, and THC as well as for its proprietary pro-drug biosynthesis platform utilizing enzymatic glycosylation.

What Is Glycosylation

Glycosylation is an enzymatic reaction that binds a carbohydrate to another molecule. In biology, glycosylation refers to the enzymatic process that attaches glycans to lipids, proteins or other organic molecules.

Glycosylation is not a new concept. High-end vitamin supplements have thirty years of experience using the process to increase the bioavailability of specific supplements.

What is novel, is Vitality’s use of glycosylation to bond sugars to CBD, THC and other cannabinoids. Studies of cannabinoid compounds show situations where the compounds are more effective against neuropathic pain than morphine and other opioids. Test show that cannabinoids are sometimes more effective than NSAIDs or corticosteroids in treating some types of inflammation.

Vitality designs pro-drugs for targeted delivery to provide greater bioavailability. Greater bioavailability allows for better dosing control and the ability to address symptoms in a specific area of the body. It is hard to root against a company seeking to provide people, especially children, with a safer form of pain-relief.

Investability

Vitality Biopharma, Inc. (OTCQB: VBIO) is an over-the-counter stock with a market cap of slightly more than $45 million. The company has an operating income loss of approximately $1 million per quarter. VBIO will need to be continually raising cash for the 3 to 7 years it takes to get a product to market.

There is some upside. The stock has an average daily volume of 250,000 shares providing good liquidity for a small investment. The shares are in a sideways upward trend after a long steady downward trend.

The company does an excellent job of telling its story. The announcement of an Orphan Drug Designation or positive clinical results might result in occasional run-ups. Conversely, negative news could send the stock into a nose dive.

VBIO is a coulda, woulda, shoulda stock. It is a high-risk equal high-reward play.

You might lose all your money, or you might turn a considerable profit over five years.

If you like the story, this could be a place to put a portion of your high-risk investment dollars. The money you invest for fun and profit, but you will shed no tears if it disappears.

 

The author has no direct stake in VBIO or ZYNE. The author might have an indirect stake in either company through ownership of shares in the Horizons Marijuana Life Sciences Index ETF (TSX: HMMJ).

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