CBDWire Editorial Coverage: America is in an opioid epidemic. On an average day, 91 Americans will die from an opioid-related overdose. That’s according to the CDC, which also reports that the number of prescription opioids sold in the U.S. has nearly quadrupled since 1999 despite no overall change in the amount of pain reported. The result is more than half a million deaths by opioid overdose from 2000 to 2015. These sobering figures reveal the desperate need for opioid substitutes, and cannabis-based therapies for pain treatment are emerging as viable alternatives. The potential rewards are significant for companies that can develop these therapies, and among those growing in recognition are India Globalization Capital, Inc. (IGC) (IGC Profile), Vitality Biopharma, Inc. (VBIO), Cara Therapeutics, Inc. (CARA), Zynerba Pharmaceuticals, Inc. (ZYNE) and AXIM Biotechnologies, Inc. (AXIM).
According to a 2016 report published by Transparency Market Research, analysts surmise that almost 20 percent of the world’s population currently suffers from chronic pain (1). As such, the global pain management therapeutics market is expected to exhibit a 3.7 percent CAGR through 2024, with market valuation increasing to US $83.0 billion by the same year.
A closer look at chronic pain explains this growth. Terminal illness, for one, is frequently accompanied by pain so agonizing, severe, and difficult to treat that death can seem like a preferable option to the patient. A key disadvantage of currently available drug therapies for chronic severe pain is that opioid-based drugs can create various side effects, including hallucinations, sedation, nausea, respiratory depression, constipation and dysphoria. Pain treatment also poses a significant challenge to health care professionals because it frequently debilitates patients in ways that hamper their day-to-day functionality, which, by extension, poses a huge productivity problem among U.S. citizens. In 2012, the annual cost of pain in the United States was estimated at between $560 billion and $635 billion—eclipsing the costs of national priority health conditions.
In light of this information, imagine for a moment the inconceivable potential of a cannabis-based combination therapy that could effectively address a large market indication. An achievement of this sort would propel an undiscovered stock straight into the spotlight. Such is the case and possibility with India Globalization Capital (IGC).
IGC aims to formulate and commercialize cannabinoid compounds as an alternative to addictive long-term opioid treatments, endeavoring to do so through a focus on combination therapy. The company is developing a portfolio of phytocannabinoid-based therapies to treat a broad range of therapeutic indications, including neuropathic and cancer pain. IGC has applied for a U.S. patent to treat pain based on a novel therapy that utilizes cannabinoid extracts. This therapy employs a cream that is applied through the use of various delivery technologies and has indications in both humans and other mammals, including dogs and cats. The company plans to conduct metabolic profiling and to run trials in the near term. IGC’s patent filing (IGC-501) is a cannabis-based formulation that addresses neuropathic and arthritic pain via various delivery techniques.
IGC’s innovative and exciting strategy is to leverage its “first mover” position to become a leader within the phytocannabinoid-based combination therapy specialty pharmaceutical sector. Developing cannabis-based combination therapies represents a huge and unique opportunity in this emerging specialty pharmaceutical sector. Obtaining FDA approval for combination therapy is typically significantly quicker and less costly than new drug applications, which means IGC can potentially bring its cannabis-based pharmaceutical products to market in a timely and thus cost-effective manner. With a market cap of approximately $11.0 million, a fraction of that of its peer group, IGC is poised to explode once its cannabis-based pain therapies obtain approval and can be brought to the market.
Another company taking aim at bringing cannabis-based therapies to market is Vitality Biopharma (VBIO), which has a market cap of approximately $51.7 million. A cure development company, Vitality Biopharma is focused on utilizing cannabinoid “prodrugs” to treat serious neurological and inflammatory disorders and to provide targeted therapies with the potential to offer long-term or durable relief and possibly help patients recover lost function.
Prodrugs are compounds or medications that, upon administration, are converted inside the body into a pharmacologically active drug that may already have a lengthy history of clinical investigation and use. As reference drugs may already have independent verification of their safety and effectiveness, some prodrugs can potentially be quickly approved by demonstrating comparable bioavailability or bioequivalence. A prodrug can simultaneously be much more marketable because of its ability to eradicate undesirable side effects or commercial aspects.
As public interest in medical marijuana applications continues to increase, clinical trials sponsored by academic investigators for using cannabinoids in the treatment of profitable, large-market disease indications is also increasing. Vitality Biopharma’s ability to quickly create proprietary prodrug versions of CBD, THC, CBVD and others positions the company to benefit from emerging data and increasing medical community recognition of the potential pain relief and anti-inflammatory effects of cannabinoids. It has become a well-established fact that cannabis has the potential to provide relief of pain and inflammation in certain disease indications, and Vitality Biopharma’s prodrugs have the potential to exert the same positive therapeutic effects as current therapies, with noteworthy improvements. Vitality Biopharma has filed intellectual property applications and is seeking global patent protection through 2035 with strong composition matter claims for prodrugs of THC, CBD and CBDV, as well as for the company’s proprietary prodrug biosynthesis platform that utilizes enzymatic glycosylation.
Another company applying the medical properties of cannabis for the treatment of pain is Cara Therapeutics (CARA), with a market cap of approximately $539.6 million. Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities, which are designed to lessen pain and pruritus by selectively targeting peripheral kappa opioid receptors. The company is developing a novel and proprietary class of product candidates designed to target the peripheral nervous system of the body and that have shown initial efficacy in patients suffering with moderate-to-severe pain. This has been demonstrated without creating many of the unwanted side effects that are normally associated with current pain therapeutics.
Studies conducted to assess the effects of cannabis have led to a recent discovery of an endogenous system of ligands within humans that are involved in various physiological processes, including pain and inflammation. The primary naturally occurring ligands for this system activate numerous cannabinoid receptors, including CB1 and CB2 receptors. CB1 receptors and associated ligands are primarily localized in the brain, while CB2 receptors are chiefly found in peripheral tissues—in particular immune cells like leukocytes and mast cells, which have been shown to have involvement in pain and inflammatory responses. Cara Therapeutics is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. The company will initially develop peripheral CB receptor modulators as a novel therapeutic approach for neuropathic pain. CR701, the company’s most advanced CB compound, is currently in preclinical development.
Zynerba Pharmaceuticals (ZYNE), with a market cap of approximately $255.8 million, is also seeking to treat a variety of severe health conditions, including peripheral neuropathic pain—in this case by applying synthetic cannabinoid therapeutics that are formulated for transdermal delivery. A clinical-stage pharmaceutical company, Zynerba Pharmaceuticals currently has two lead product candidates in its development pipeline: ZYN002 and ZYN001. These product candidates are being evaluated in five therapeutic indications. ZYN002 is the first and, currently, the only synthetic CBD, which is a non-psychoactive cannabinoid. It has been formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin into the body’s circulatory system and is in phase 2 clinical development. ZYN001 is a prodrug of THC that facilitates transdermal delivery through the skin and into the circulatory system through a patch. A phase 1 clinical trial of ZYN001 is planned to commence in 2017.
AXIM Biotechnologies (AXIM), with a market cap of approximately $410.5 million, is focused on the research, development and production of cannabinoid-based pharmaceutical products and supplements. The company owns the patent for the use of chewing gum as a cannabinoid delivery method, and its MedChew RX gum will soon commence phase 3 clinical trials for the treatment of pain and spasticity related to multiple sclerosis. This pharmaceutical, functional chewing gum contains equal portions of THC and CBD. Thanks to the company’s proprietary technology, various problems related to the water insolubility of cannabinoids have been addressed and resolved. Based on AXIM’s proprietary intellectual property, a new direct and controlled slow-release nano-technology delivery method is planned to be investigated. Various other R&D projects are also being considered that involve AXIM’s proprietary intellectual property.
There is no denying the power and potential of cannabis-based therapies for pain management, and investors have the opportunity to scout the playing field of this market to identify the most promising companies. This growing segment of the health care field increasingly demonstrates favorability by addressing key health issues that affect people in the United States and around the world.
(1) Transparency Market Research http://nnw.fm/uL54B
For more information on India Globalization Capital visit India Globalization Capital (IGC)
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