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By PharmaCompass
2022-07-07
Impressions: 3307
Cannabis has been used to treat pain and other ailments since time immemorial, albeit not without controversies over the legal, ethical and societal implications of its use. Cannabinoids, or naturally occurring compounds found in the Cannabis sativa plant, have found wider acceptance within the scientific and medical community over the last few years.
Along with the more well-known cannabinoids, such as cannabidiol (CBD) and tetrahydrocannabinol (THC), there are over 140 rare cannabinoids that occur in extremely low amounts in the cannabis plant and are believed to offer distinct health and wellness benefits. Some of the rare cannabinoids of current interest include cannabigerol (CBG), cannabinol (CBN), cannabidivarin (CBDV), cannabidiorcin (CBDO) and tetrahydrocannabivarin (THCV).
The pharmaceutical industry has seen a stupendous rise in research, technologies and drugs based on cannabinoids. The global cannabinoids market is growing at a fast clip of 22.2 percent and was valued at US$ 22.2 billion in 2021. It is projected to reach US$ 154.2 billion by the end of 2031. The retail market for rare cannabinoids is growing at over 20 percent and is expected to reach US$ 26 billion by 2028.
PharmaCompass’ Technology Prospector, a proprietary technology, found over 2,000 organizations across 64 countries that have either patented or published works related to cannabinoids. The US has the maximum number of active organizations followed by Canada, the UK and China.
Besides pharmaceuticals, CBD also has non-medical uses, such as in foods, cosmetics and textiles. CBD edibles such as gummies and chocolates are becoming popular due to their stress-relieving and antioxidant properties.
The prominent CBD players are Ireland-headquartered Jazz Pharmaceuticals, Canadian companies Canopy Growth, InMed, MediPharm Labs, Aurora Cannabis and the Cronos Group, Danish firm NordicCan and American drugmakers Ginkgo Bioworks, Zynerba Pharma and Tilray.
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Drugmakers leverage biosynthesis to develop therapeutic cannabinoids
Amongst processes that are deployed to produce therapies, cannabinoid biosynthesis holds considerable promise. It uses simple living organisms, such as yeast, to develop targeted therapeutic cannabinoids and holds the potential of improving the economics for the production of rare cannabinoids.
Using biosynthesis, Cronos and Ginkgo Bioworks have successfully fermented cannabigerol (CBG) and launched Spinach Feels Chill Bliss 2:1 THC|CBG last year. As the name suggests, the drug relaxes the consumers, while also uplifting their mood.
Last month, InMed launched delta 9-dominant tetrahydrocannabivarin (d9-THCV), another rare cannabinoid. InMed is the first company to advance cannabinol or CBN into a clinical trial. CBN is the active pharmaceutical ingredient (API) in two of InMed’s drug development programs — INM-755 cannabinol cream, which is in phase 2 clinical development for epidermolysis bullosa (a rare genetic skin disease characterized by fragile skin), and INM-088 CBN eye drops, which is in preclinical development for glaucoma.
Demeetra has gone a step further and leveraged its precision gene editing tools in combination with biosynthesis to produce targeted therapeutic cannabinoids. It is using a synthetic biotechnology approach in yeast to produce very rare and novel cannabinoid-like molecules.
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Jazz Pharma to set up new plant for CBD-based medicines in UK
After several years of rising M&A activity, there was a slump in deals in the cannabis and cannabinoid space during 2019 and 2020. From over 300 transactions, valued at over US$ 7 billion in 2018, total M&A deals in the space fell to 124 in 2020, with a transaction value of only around US$ 1.9 billion. But last year saw a significant deal in the CBD space — i.e. the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals for US$ 7.2 billion.
In March this year, GW Pharma — now Jazz Pharma’s cannabinoid subsidiary — began construction of a new UK manufacturing plant in Sittingbourne, which is specifically designed for cannabis-based medicines.
GW Pharma is the maker of the first prescription cannabinoid medicine approved by the US Food and Drug Administration (FDA). The drug — Epidiolex — is an oral solution of cannabidiol derived from the cannabis plant. In 2018, FDA approved the use of this drug to treat Lennox-Gastaut syndrome and Dravet syndrome, two severe early-onset epilepsies. Since then, the drug has also been cleared for tuberous sclerosis complex, an uncommon genetic disorder that causes noncancerous (benign) tumors. Epidiolex is currently in phase 3 for epilepsy with myoclonic-atonic seizures (EMAS).
However, just last month, Jazz Pharma suffered a setback after a cannabinoid treatment it had acquired from GW Pharma failed a phase 3 trial. Over 21 days, the spray (nabiximols) failed to improve lower-limb muscle tone as measured by the Modified Ashworth Scale (MAS) in patients with multiple sclerosis (MS) spasticity.
Companies such as Canopy Growth Corp, Aurora Cannabis, Zynerba Pharma and Hoth Therapeutics are developing products targeting the cannabinoid system in the human brain and body. Canopy Growth has spent over US$ 4.77 billion in making 13 acquisitions and three investments in the cannabinoid space. In October 2021, Canopy Growth announced plans to acquire Wana Brands, a leading cannabis edibles brand in North America.
The FDA is encouraging clinical trials for CBD-based therapies. In May this year, Cardiol Therapeutics, a clinical-stage life sciences company focused on the research and clinical development of CBD, announced that the US agency has authorized its investigational new drug application (IND) to commence a phase 2 open-label pilot study that evaluates the tolerance and safety of CardiolRX, an oral cannabidiol drug formulation, in patients with recurrent pericarditis.
Many countries have been encouraging the use of CBD in drugs. In September 2021, Aurora Cannabis, a Canadian company, launched Bidiol, its first medical CBD product, in Uruguay. Bidiol is used for the treatment of refractory epilepsy in children and adolescents. In May 2022, the company received EU-GMP certification for its medical cannabis production facility in Germany.
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Experimental cannabinoid drugs to treat autism, cancer, lupus, anxiety disorders
Cannabidiol is being tested to treat rare diseases. One such experimental treatment is Zynerba’s Zygel (ZYN002 cannabidiol gel), the first and only pharmaceutically produced CBD. This is a non-euphoric cannabinoid, formulated as a gel for transdermal delivery. Zygel is being developed for patients suffering from Fragile X syndrome (a genetic disorder), autism and 22q11.2 deletion syndrome (a disorder caused when a small part of chromosome 22 is missing). The gel is an experimental treatment that is not approved by regulatory bodies. Last month, Zynerba announced positive results from a phase 2 trial of Zygel in 22q11.2 deletion syndrome.
Cancer cures through cannabinoids is another emerging area. CNBX Pharma, a global leader in the development of cancer and cancer-related cannabinoid-molecule-based formulations, has completed preclinical development of a novel formulation containing cannabinoids — CNBX RCC-33 — the world’s first cannabinoid-based anti-tumor drug candidate for the treatment of colorectal cancer.
Cannabinoids are also being explored for the treatment of auto-immune diseases. In December 2021, Hoth Therapeutics tied up with Zylö Therapeutics to license its novel cannabinoid med for lupus — HT-005 — back to Zylö. Hoth had an exclusive license to develop HT-005. At present, the therapeutic options for cutaneous lupus erythematosus (CLE) are limited to steroids (topical and oral), topical calcineurin inhibitors and other immunomodulating therapies that could have adverse effects due to long-term usage. If approved, HT-005, which has been successfully tested in animals, will offer another option for treating CLE.
The use of CBD to treat anxiety has shown substantial progress. Receptor Life Sciences has developed RLS103, a dry powder inhaled cannabidiol (CBD) for the treatment of social anxiety disorder. FDA has accepted the IND application for RLS103 and the company recently initiated the phase 1b/2a study.
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Tech advancements offer new insights into potential uses of cannabinoids
Although cannabinoids have attracted attention for centuries, technological advancements over the last few decades have brought new and scientifically well-founded insights into their therapeutic potential.
Zelira has developed an enhanced dissolution of cannabinoids technology and used it in three of its products — a treatment for chronic insomnia, an organic tincture for autism and a new CBD-toothpaste which has been marketed to eliminate decay-causing bacteria, reduce gum inflammation and restore pH balance.
In April, MediPharm Labs, a pharmaceutical company specializing in precision-based cannabinoids, launched CBG and water-soluble products in Canada. With these launches, MediPharm has expanded its portfolio to include the first range of naturally-derived CBG products and the only inhalable CBG option available in Canada. CBG is one of the rarer cannabinoids and has demonstrated some potential as an antibiotic.
MediPharm is also launching a water-soluble liquid solution, Northbound Night Cap, that leverages its proprietary water-soluble emulsification technology. In November 2021, the company had announced the expansion of its cannabinol (CBN) product line. It also entered the US market this year with the completion of the FDA DMF process for natural CBD APIs. This is a first for CBD by a Canadian company.
In October 2021, Lipidor expanded its collaboration with Cannassure Therapeutics to include a new patented drug delivery technology — AKVANO — which is water-free and sprayable. This technology will be used in the development of topical medicinal cannabis products for the treatment of psoriasis.
In December 2021, Tilray Inc had announced that its medical subsidiary Aphria has launched medical cannabis oral strips in THC and CBD-rich varieties. Each strip contains a thin, edible film that dissolves quite rapidly. It contains micronized cannabinoids that are absorbed directly into the bloodstream, providing patients fast relief from a range of conditions. Last month, Tilray Brand Inc announced that its medical cannabis division, Tilray Medical, has expanded its medical cannabis offerings in the UK.
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Our view
New technologies and the legal acceptance of the use of CBD in some countries has given a sharp impetus to the medical cannabis industry. In 2018, FDA had approved the first CBD-based epilepsy drug — Epidiolex. However, post that approval, no new CBD drug has been approved by the US agency.
The FDA has stringent regulations governing cannabinoids and a drug like GW Pharma’s Sativex (an oil spray containing THC and CBD) that is permitted in many countries to treat aches associated with multiple sclerosis has not been approved by the FDA, despite several trials that have been conducted over the years. In May this year, the FDA issued warning letters to five companies for selling products containing delta-8 THC that violate the Federal Food, Drug, and Cosmetic Act.
Since the drug review process in the US is recognized worldwide as the gold standard, the future of cannabinoids is heavily dependent on how the FDA decides to formally regulate their use in drugs. Rapid advancements in technologies around cannabinoids will be difficult for FDA to ignore.
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Image Credit : Biosynthesis, tech advancements by PharmaCompass is licensed under CC BY 2.0
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