NetworkNewsWire Editorial
Coverage: The $58.6
billion global market for pain management drugs is on track to hit
upward of $77.1 billion by 2023 on a 4 percent CAGR. North
America was the largest segment of this massive market last year,
and opioids were the biggest driver of growth due to their efficacy
in managing severe chronic pain. However, this efficacy is
dramatically offset by the enormous economic cost of what is
now officially a
nationwide crisis. Opioid abuse, addiction and overdose deaths
cost an estimated 2.8 percent of GDP in 2015 alone (over $504
billion) according to the Council of Economic Advisers. This
escalating public health crisis has thrown a bright spotlight on
new pain management alternatives void of addictive components and
reduced adverse side effects. The need for alternatives like
cannabinoid-based therapies is generating significant market
interest for prospective solution developers such as
InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)
(IMLFF
profile), a preclinical-stage
biopharmaceutical company focused on developing its pipeline of
novel therapies based on the integration of the pharmacology of
cannabinoids and innovative drug delivery systems. InMed’s approach
to the therapeutic potential of cannabinoids is what differentiates
it from others in the biotech space, such as GW
Pharmaceuticals (NASDAQ: GWPH), Zynerba
Pharmaceuticals (NASDAQ: ZYNE), Cara
Therapeutics, Inc. (NASDAQ: CARA) and
Axim Biotechnologies (OTC: AXIM).
While most cannabis-focused biotechs funnel their resources and
time into the development of medicines using the two most common
cannabinoids — tetrahydrocannabinol (THC) and cannabidiol (CBD) —
InMed
Pharmaceuticals, Inc.’s (CSE: IN) (OTCQB:
IMLFF) proprietary biosynthesis process has demonstrated
capabilities that allows the company to consistently manufacture
all of the 90-plus naturally occurring
cannabinoids in-house, eliminating the expenses of growing or
buying cannabis plant matter to develop its pipeline of
therapies (http://nnw.fm/dGPc0).
The company’s ability to create bio-identical,
pharmaceutical-grade cannabinoids is a
crucial differentiator that enables InMed to also address two
primary challenges to the research and development of cannabinoids.
Typically, the research of cannabinoids for the treatment of
disease is marked by two factors: First, it is obstructed by the
fact that these compounds occur in very low concentrations of the
cannabis plant and second, it is limited by the exorbitant costs of
isolating sufficient quantities of cannabinoids needed to conduct
research.
InMed’s proprietary biosynthesis technology, however, is a game
changer, placing the ability to extract high yields of minor
cannabinoids within the realm of commercial viability and
unprecedented medical research.
This is particularly key as the company advances its INM-405
candidate for the treatment of pain. Recent pre-clinical data from
the company’s pain treatment program (http://nnw.fm/4ICzO) suggests that topical application
of certain non-THC cannabinoid compounds is effective in treating
peripheral pain in craniofacial muscle pain disorders.
This achievement builds on the company’s proof-of-concept study
results published earlier this year in the European Journal of
Pain, suggesting that THC could reduce masticatory muscle pain
through the activation of peripheral cannabinoid receptors CB1 and
CB2, which are primary targets in the human body for cannabinoid
drugs.
As the need remains for non-addictive pain management
alternatives with limited side effects, InMed continues to research
the potential of non-THC cannabinoids to treat pain using a topical
formulation. The company recently filed a provisional patent
application in the United States for INM-405 and other unique
cannabinoid-based topical therapies for the treatment of pain,
recognizing that the significant unmet need for a topical analgesic
without the typical systemic exposure and side effects represents a
huge target.
InMed’s chief scientific officer and co-inventor on the patent,
Dr. Sazzad Hossain, in a press release announcing the filing was
keen to point out how InMed's focus on non-psychoactive
cannabinoids further reduces the entire industry’s prevailing
concerns about addiction.
"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," he stated (http://nnw.fm/xc4uV). "InMed's focus on
non-psychoactive cannabinoids further reduces concerns regarding
addiction, a key concern in pain management."
According to the Centers for Disease Control (“CDC”), more than
60,000 people in the United States were killed by drug overdoses in
2016, an increase of 22 percent compared to the year prior. Drug
overdoses are expected to remain the leading cause of death in
Americans under the age of 50, and the CDC report notes that
synthetic opioids are leading to an uptick of drug-related deaths.
The use of drugs such as fentanyl increased 72% from 2014-2015
(http://nnw.fm/pU2El).
In light of these statistics, the race is heating up for a way
to curb the dramatic increase in the number of prescriptions for
opioids. A topical cannabinoid product for pain management,
particularly a non-THC based one, could be just the ticket.
InMed’s INM-405 patent cites a range of topically applied
cannabinoids (alone or in combination) for the treatment of a
variety of pain types ranging from muscle and nerve to
arthritis-induced joint pain, providing for the company an
opportunity to tap into the osteoarthritis market, which is
expected to reach $3.5 billion by 2026, and the market for
orofacial pain, pegged at $6 billion a year.
This approach not only represents a vastly preferable solution
compared to orally administered pain relievers, it dovetails
perfectly with InMed’s biosynthesis program to produce commercial
quantities of cannabinoids for other candidates in is pipeline,
which includes INM-750 for the treatment of Epidermolysis Bullosa
(genetic condition characterized by fragile, blistering skin), and
INM-085 for the treatment of the optic nerve-damaging, degenerative
disease glaucoma.
As InMed focuses on scaling-up and commercializing this
biosynthesis platform, the company has tapped leading cannabinoid
researchers to assist with its progress. In September the company
retained the consulting services of Ben Paterson, P.E., who has
nearly four decades of experience in developing processes for
pharmaceutical manufacturing and purification, including all facets
of biosynthesis manufacturing and facility design (http://nnw.fm/Ug7Ok). Paterson was previously a senior
engineering advisor with Eli Lilly and Company, where he spent 37
years, including 24 years in its biosynthesis division. InMed
next named to its Scientific Advisory Board Dr. Mauro Maccarrone,
professor and chair of biochemistry and molecular biology at Campus
Bio-Medico, University of Rome (http://nnw.fm/3DYAn).
InMed’s ongoing development of its proprietary biosynthesis
platform recently saw what the company believes to be two
significant industry firsts (http://nnw.fm/S9H3z): a new and substantially more
robust metabolic pathway capable of manufacturing the
much-sought-after terpenoid family of cannabinoid precursors
(diverse organic compounds typically in the form of aromatic oils),
as well as the first production of fully assembled cannabinoids
that are bio-identical to the 90-plus known plant-based
cannabinoids.
This unique technological advantage not only gives InMed a
serious leg up when it comes to cost-effectively producing the raw
materials the company needs to advance its own pipeline, but could
also have a major impact on other biotech companies developing
cannabinoid-based therapeutics as well. This technology has the
potential to become an industry standard when it comes to
cost-effectively obtaining large quantities of the many different
cannabinoids required by tomorrow’s breakthrough therapies.
GW Pharmaceuticals plc (NASDAQ: GWPH) is
looking for a new drug application decision from the FDA on an
orphan drug designated Epidiolex (purified, plant-derived
cannabidiol) for Dravet syndrome and Lennox-Gastaut syndrome
(epilepsies) by as early as the middle of
2018 (http://nnw.fm/rNVu6). The company is also prepping for
European regulatory approval coming off a landmark publication in
The New England Journal of Medicine, as well as key
presentations at the American Academy of Neurology and American
Epilepsy Society annual meetings. GW Pharmaceuticals is also
advancing a number of additional clinical programs and could make
good use of a cost-effective, robust and more articulable process
for obtaining the raw materials that go into its indications.
Zynerba Pharmaceuticals (NASDAQ: ZYNE),
developer of products like ZYN002, the first and only
pharmaceutically made CBD formulated as a patent-protected
permeation-enhanced gel, is another good example. A
permeation-enhanced transdermal gel, ZYN002 is targeting the
developmental genetic condition known as Fragile X syndrome (orphan
drug designation obtained), as well as focal seizures and
osteoarthritis. The company is also advancing a pro-drug of THC
called ZYN001 for fibromyalgia and peripheral neuropathic pain. The
company cites clinical data suggesting that THC and CBD have a high
therapeutic index with low toxicity in support of its development
pipeline’s potential (http://nnw.fm/LoQH1). It is intriguing to
imagine a future where biosynthesis technology bridges the gap
between the benefits of natural plant extracts and
laboratory-manufactured, pharmaceutically produced cannabinoid
variants.
Cara Therapeutics (NASDAQ: CARA) is
a clinical-stage biotech focused on developing and commercializing
new chemical entities for the management of acute pain, chronic
pain and pruritus (itch). The company’s approach is to
develop new products that selectively target the body’s peripheral
kappa opioid receptors. Cara is developing a novel and proprietary
class of product candidates that target the body’s peripheral
nervous system and have demonstrated initial efficacy in patients
with moderate-to-severe pain and pruritus without inducing many of
the undesirable side effects typically associated with currently
available pain and itch therapeutics. The company’s most advanced
compound, CR845, is currently undergoing clinical testing. As
reported on the company’s website, results from multiple
randomized, double-blind, placebo-controlled phase 2 trials in
patients undergoing laparoscopic hysterectomy or bunionectomy
procedures, show that I.V. CR845 treatment resulted in
statistically significant reductions in both pain intensity and
opioid-related side effects.
Axim Biotechnologies (OTCQB:
AXIM) focuses on the research,
development and production of cannabis-based pharmaceutical,
nutraceutical and cosmetic products. The company’s line of flagship
products include CanChew+®, a CBD-based controlled release chewing
gum; CanChew+ 50®, which contains 50 mg of CBD and is undergoing
clinical trials in patients with irritable bowel syndrome (“IBS”);
and MedChew Rx®, a combination CBD/THC gum that will undergo
clinical trials for the treatment of pain and spasticity associated
with multiple sclerosis. AXIM has several products developed or in
developmental stage for treatment and/ or prevention of multiple
conditions and symptoms. Axim is precisely the kind of multi-front
developer which could benefit mightily from InMed’s biosynthesis
technology.
The mounting need to find effective, non-addictive alternatives
to existing medications like opioids for treating chronic and
severe pain will continue to draw attention to trailblazers such as
InMed. The potential of cannabinoid-based therapies, which lack the
crippling and even deadly side effects of opioids, is only starting
to be properly understood when it comes to addressing these
objectives. The ability to produce large quantities of otherwise
not commercially viable cannabinoids for select combination
therapies that can be administered topically is quite possibly the
most disruptive development yet witnessed in the still-young
cannabinoid therapy space.
Thus, a company like InMed, with an attractive pipeline under
development and proprietary biosynthesis technology it can exploit
or even license out, is one for investors to keep an eye on.
For more information on InMed Pharmaceuticals, please visit:
InMed
Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF).
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