Advanced Biosynthesis Setting New Standards for Cannabinoid-based Pain Management

NEW YORK, December 6, 2017 /PRNewswire/ --

Cannabis derivatives have been used medicinally around the world for millennia. However, concerns surrounding potential dangers and abuse of marijuana's psychoactive component THC (tetrahydrocannabinol) led to the banning of medicinal cannabis early in the 20th Century. Recent scientific studies, however, have given new credence to the wisdom from millennia ago and have scientifically proven the medical efficacy of certain cannabinoids for developing new approaches to treating diseases with high unmet medical needs. Global scientists, researchers and biopharmaceutical companies are now focused on cannabinoids that have therapeutic potential. One pioneering biopharmaceutical company, InMed Pharmaceuticals, Inc. (CSE: IN) (OTC: IMLFF) (IMLFF profile), has triggered a paradigm shift in discovering potential breakthrough cannabinoid-based therapies. InMed Pharmaceuticals utilizes its robust, proprietary biosynthesis process to isolate and create pharmaceutical grade, bio-identical cannabinoids in the laboratory where it can cost-effectively manufacture any of the 90+ cannabinoid compounds at pharmaceutical-grade (greater than 95 percent) purity. InMed also employs its proprietary bioinformatics assessment tool to determine therapeutic approaches for specific diseases by analyzing pharmaceutical and cannabinoid structures to identify associations between approved pharmaceuticals and particular cannabinoids to attain parallel biological responses. The company's combination of comprehensive proprietary processes sets it apart from others trying to compete in this arena. Other companies on the trail of new cannabinoid medicines and drug classes include GW Pharmaceuticals (NASDAQ: GWPH), Zynerba Pharmaceuticals (NASDAQ: ZYNE), Cara Therapeutics, Inc. (NASDAQ: CARA) and Axim Biotechnologies (OTC: AXIM).

Other biopharmaceutical companies may produce cannabinoids in the laboratory using chemical synthesis, but there's a litany of drug development efforts with synthetic molecules that have failed. The proprietary biosynthesis process used by InMed Pharmaceuticals, Inc.'s (CSE: IN) (OTCQB: IMLFF) is unique. Producing cannabinoids that are identical to naturally occurring compounds is transformative for drug development. By using its proprietary process, InMed is able to manufacture exact cannabinoid replicas for use in research. This novel breakthrough gives InMed scientists the ability to manufacture all 90+ cannabinoid compounds identical to those found in nature and the ability to consistently, reliably and accurately test efficacy and safety. In addition, InMed's cost-effective biosynthesis process enhances production, purification, and quality control as opposed to other chemical manufacturing methods. InMed's biopharmaceutical approach to the production of pharmaceutical grade, bio-identical cannabinoids is disruptive in the development of pharmaceutical cannabinoids for research and drug creation. The company's high-yield manufacturing process also provides simpler scale-up and systems optimization, as well as the production of minor cannabinoids that are economically impractical to extract from plant sources.

To protect this invaluable asset, InMed has filed a provisional patent for the biosynthesis of cannabinoids (http://nnw.fm/RPTj0 ), and the company continues to use the technology to expand its pipeline for treating a variety of medical conditions.

InMed's cannabinoid biosynthesis process is complemented by its bioinformatics drug and disease targeting tool. Bioinformatics is a high-efficiency, computer-assisted approach to predicting the therapeutic potential and medicinal properties of individual cannabinoids against particular medical conditions. InMed's proprietary approach applies comprehensive algorithms to integrate the data from various bioinformatics databases, including a vast database of the chemical structures of approved pharmaceuticals, with InMed's proprietary cannabinoid database and know-how.

Study results published earlier this year by InMed in the European Journal of Pain (NR July 27, 2017) highlighted the topical application of cannabinoids to successfully treat peripheral pain, and on October 17, 2017 the company issued an update on its cannabinoid-based pain drug program (http://nnw.fm/o8rPL ) to include the potential of non-THC cannabinoids for pain management.

Pre-clinical results in the development of the company's INM-405 candidate for the treatment of pain suggest that peripheral application of certain cannabinoid compounds, alone or in combination, is effective in the treatment of craniofacial muscle pain disorders such as temporomandibular disorders (TMD) and trigeminal neuralgia (TN) - without any observed central nervous system side effects.

TN in particular is known for symptoms involving intense and uncontrollable face and jaw spasms, causing pain that is so severe it has been nicknamed "the suicide disease ." It is estimated that 12 new cases of TN occur per 100,000 persons every year, according to the National Institute of Neurological Disorders and Stroke.  Sufferers have found some relief smoking marijuana, but must do so frequently and are subject to protracted psycho-activity caused by THC. InMed recognizes the need and market opportunity for non-opioid alternatives to treat chronic and severe pain with limited side effects.

InMed has since filed a provisional patent application for INM-405 and other unique compositions as cannabinoid-based topical therapies for the treatment of pain (http://nnw.fm/K0MRo ), noting the need for therapies centered on specific non-psychoactive cannabinoids.

"There remains a significant need in the field of analgesia for a product that can treat pain via a topical route of administration, which would reduce systemic exposure and any associated side effects," Dr. Sazzad Hossain, chief scientific officer of InMed Pharmaceuticals and a co-inventor on the patent, stated in the October 3 press release. "InMed's focus on non-psychoactive cannabinoids further reduces concerns regarding addiction, a key concern in pain management."

Pain management represents only a sliver of the market potential for InMed's pipeline as it relates to broader demand for cannabinoid-based therapies. The company's comprehensive pharmaceutical approach to cannabinoid drug development may likely set a new standard in cannabinoid pharmacology.

As evidenced by the size and application of such innovations by other biotech leaders, the market opportunity for InMed could be substantial.

One of the most recognized names in cannabinoid medicine is GW Pharmaceuticals plc (NASDAQ: GWPH). Researching cannabinoids since 1998, the company is focused on developing and commercializing therapeutics from its cannabinoid product platform across a range of disease areas. GW's lead cannabinoid product candidate is a liquid formulation of pure plant-derived cannabidiol (CBD). The company has established industry leadership through the early development of plant-derived therapeutics, drug discovery processes, manufacturing and regulatory expertise, and a portfolio of intellectual properties. The company developed the world's first prescription cannabis-derived medicine, Sativex, which is approved for use in countries outside of the United States for the treatment of multiple sclerosis spasticity. GW's lead cannabidiol product candidate, Epidiolex, is in development for the treatment of a number of rare childhood-onset epilepsy disorders.

Zynerba Pharmaceuticals (NASDAQ: ZYNE) is a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutically produced transdermal cannabinoid treatments for patients with high unmet medical needs. Engaged in the research and development of cannabinoid drugs, the company has developed a synthetic transdermal cannabinoid product in the form of a gel that enables compounds to pass through the skin and into the blood supply. A skin patch is also available. Zynerba's development pipeline includes patent-protected pharmaceutically-produced transdermal cannabinoid products. The company has been working on cannabinoid-based treatments for Fragile X syndrome, epilepsy, osteoarthritis, fibromyalgia and peripheral neuropathic pain.

Cara Therapeutics, Inc. (NASDAQ: CARA) is a clinical-stage biotech company looking to change how pain is treated. Its portfolio includes opioid-based products, anesthetic-based drugs, and analgesics that seek to alleviate itch and pain. Cara is developing a new class of medicine called Kappa Opioid Receptor Agonists (KORAs).  KORAs target a completely different receptor in the body, the kappa opioid receptor, to treat pain in a fundamentally new way. The company's lead pipeline product, CR845, is a peripherally acting type of KORAs. To date, CR845 has shown in phase II clinical trials promising pain relief without many of the traditional side effects of opioids and NSAIDs.

Axim Biotechnologies (OTCQB: AXIM) engages in the research, development, and production of pharmaceutical, nutraceutical, and cosmetic products. It focuses on the treatment of pain, spasticity, anxiety, and other medical disorders with the application of cannabinoid based products. Research in the use of molecularly modified cannabinoids as neuroprotectants is currently being conducted and the use of industrial hemp-derived CBG-containing (cannabigerol) formulations for dermatological applications is also being researched. The company's MedChewRx™ is undergoing clinical studies. The company's chewing gum is the first preparation of its kind, under study for not only its proprietary active pharmaceutical ingredients but also for unique additional benefits via the act of mastication.

The medicinal wisdom from millennia ago is being borne out by the science of today. There's immense promise for patients in medicinal cannabis therapies and incredible economic opportunity for companies like InMed using innovative technology with the goal of bringing blockbuster cannabis-based drugs to market.

For more information on InMed Pharmaceuticals, please visit: InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)

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