NetworkNewsWire
Editorial Coverage: Pain is a wide-ranging complex medical
condition that can be both physically debilitating and mentally
destabilizing. Whether acute or chronic, caused by disease, trauma
or neural damage, current pain therapeutics primarily rely on a
variety of opioid-based pharmacological therapies that have ignited
a severe public health crisis. The rampant dependency and abuse of
opioid-based drugs has triggered a global quest for effective
opioid free medications. Societal demands and sheer market size
have bio-pharmaceutical companies searching for solutions to
address the critical need for new ways to successfully treat pain.
Establishing a new paradigm in pain management solutions,
PreveCeutical Medical, Inc. (CSE: PREV) (OTCQB: PRVCF)
(FSE: 18H) (PRVCF
Profile) has undertaken a novel
approach in the development of non-addictive analgesics by
engineering peptides into efficient pain blockers, eliminating
highly addictive opioids. Other companies in the hunt for pain
management solutions include AcelRx Pharmaceuticals, Inc.
(NASDAQ: ACRX), Nektar Therapeutics (NASDAQ:
NKTR), Flexion Therapeutics, Inc. (NASDAQ:
FLXN) and Cara Therapeutics (NASDAQ:
CARA).
Global Pain Therapeutics Market
The global pain management therapeutics market has
demographically inherent growth potential due to the expanding
population affected by medically significant pain. The market is
being driven by an increasing geriatric population, an increasing
number of surgeries, and, in conjunction with longer life
expectancy, a higher prevalence of chronic disorders such as
arthritis pain, back pain as well as cancer and post-operative pain
relief.
As such, the global market for pain management drugs exceeded
$62 billion in 2016 and is estimated to surpass $88 billion by 2025
(http://nnw.fm/Oj9Tm). Opioid-based drugs are
the leading treatments for severe and chronic pain, but they can be
highly addictive. Their abuse results in thousands of overdose
deaths in the United States annually. They can cause motor
impairment and potentially fatal respiratory depression. Patients
also build up tolerance over time, increasing the risk for abuse
and overdose. To adequately address the burgeoning global need for
effective pain medications and break the cycles of dependence and
abuse of opioids requires creative new approaches.
Peptides and Pain Therapeutics
Normally, when the body experiences pain, naturally occurring
peptides, such as endorphins and other chemicals, bind to receptor
sites in the brain to reduce discomfort. Peptides have the
potential to be powerful pharmaceutical agents for the treatment of
pain, devoid of opioid side-effects. Unfortunately, peptides don’t
easily enter the central nervous system due to the blood-brain
barrier. Peptides also easily degrade reducing therapeutic value.
To efficiently bind to brain receptors and become effective pain
therapeutics, peptides must have increased bioavailability to
enhance brain uptake.
In what may be a breakthrough approach to address the critical
demand for non-additive pain medications, PreveCeutical Medical Inc. (CSE: PREV) (OTCQB:
PRVCF) (FSE: 18H) is set to engineer peptides with
greatly increased stability and potency and develop non-addictive
analgesics for moderate-to-severe pain. In August 2017,
PreveCeutical and UniQuest Pty Limited, the main commercialization
company for the University of Queensland, signed a letter of intent
proposing expansion of the use of their disulphide linker
technology to determine efficacy in pain and inflammation (http://nnw.fm/aQx5D).
“This is a very exciting and important program as we focus on
engineering a novel class of drugs derived from our very own
endogenous pain pathways, for example when pain and inflammatory
insults occur. Our preliminary work has highlighted that by using
our proprietary linker technology we can enhance stability while
maintaining, and in some cases enhancing the potency of lead
bioactives,” explained Dr. Harry Parekh, PreveCeutical’s chief
research officer and lead researcher at the University of
Queensland’s School of Pharmacy (http://nnw.fm/ukgA1). Enhancing the stability and
potency of bioactives may well enhance brain uptake, allowing
peptides to bind to receptors and block pain signals.
This exciting pathway to new pain management solutions was
solidified earlier this week when PreveCeutical announced the
definitive agreement on the collaboration. The four-phase research
program will be led by Dr. Parekh and carried out in collaboration
with pain and inflammation pharmacology experts at the University
of Queensland. PreveCeutical will own all intellectual property and
UniQuest, the IP and research commercialization company of the
University of Queensland, will receive payments for development
milestones and sales-based royalties in accordance with the terms
of the research agreement.
In what may become the precursor to solving the vast and vexing
problems in pain management, the parties intend to commence
research March 1, 2018.
Ingenious Advancements
With no less an objective than to be a global leader in
preventive health sciences, PreveCeutical is initiating innovative
options for a broad spectrum of preventive and curative therapies
by utilizing organic and nature identical products. The company has
already brought one product to market, and is developing a diverse
portfolio of research and development programs that target some the
largest market maladies.
Founded in 2009, PreveCeutical Medical’s first product, CELLB9®,
is an oral dilute solution infused with select peptides. The active
ingredients in CELLB9 have been used around the world for over 25
years, and like cannabis before definitive research, have generated
volumes of anecdotal reports of efficacy. PreveCeutical’s highly
respected research team is now using proprietary chemistry to
generate Nature Identical™ peptides derived from natural compounds
found only in Caribbean Blue Scorpion venom. PreveCeutical, and its
Australian research commercialization partner Uniquest, are
currently screening these peptides across some of the most
aggressive diseases where there exists unmet clinical need, such as
cancer. Peptides are also being used to target an array of disease
indications including pain management, metabolic disorders,
cardiovascular and infectious diseases.
Development Pipeline
The company’s wide-ranging development program includes the
development of Sol-gel, the first nose-to-brain delivery system for
superior time released delivery of cannabinoid (CBD) based
medications. Bypassing typical delivery techniques, this nasal
spray formulation rapidly gels upon contact with mucosal tissue to
effectuate targeted drug delivery directly to the brain. This
patented formula is anticipated to be commercially launched with
licensed medical cannabis companies within 18 months, and has
potential applications beyond CBD.
In conjunction with leading Australian research centers,
PreveCeutical is also pursuing dual-gene therapy research as both a
preventative measure and possible treatment for diabetes and
obesity. Over five years of multi-disciplinary research has
generated convincing results in disease models that a single gene
may be implicated in Type 2 diabetes and obesity. PreveCeutical’s
gene-silencing technology would effectively turn off the genetic
signal which leads to the over-production of a key protein
molecule, in turn reducing blood sugar levels and preventing the
body from storing excessive fat.
A statement by Dr. Parekh emphasizes the value of this
capability: “…gene-silencing does not represent a mere management
for diabetes and obesity, it represents the potential for a bona
fide cure…”
Other Players in the Value Chain of New Pain Management
Drugs
Peptides are currently used to target an array of disease
indications, with broader market growth driven by the introduction
of new technologies designed to enhance stability and
bioavailability. In this regard, Preveceutical continues to advance
its pain program, positioned to capture its share of the rapidly
expanding therapeutic peptide market.
Potential industry comparables include:
AcelRx Pharmaceuticals (NASDAQ: ACRX) is
focused on the development and commercialization of innovative
therapies for the treatment of moderate-to-severe acute pain.
AcelRx's proprietary, non-invasive sublingual formulation
technology delivers sufentanil (a synthetic opioid analgesic drug)
with consistent pharmacokinetic profiles. The company has two
product candidates including DSUVIA™ (sufentanil sublingual tablet,
30 mcg), with a proposed indication for the treatment of
moderate-to-severe acute pain in medically supervised settings, and
ZALVISO® being developed as an innovatively designed
patient-controlled analgesia system for reduction of
moderate-to-severe acute pain in medically supervised settings.
A global leader in polymer chemistry, research-based
biopharmaceutical Nektar Therapeutics (NASDAQ:
NKTR) seeks to discover and develop innovative medicines
by creating new molecular entities with optimized pharmacology to
address an array of unmet medical needs. The company’s R&D
pipeline of new investigational medicines includes treatments for
cancer, auto-immune disease and chronic pain. Nektar leverages its
proprietary and proven chemistry platform in the discovery and
design of new therapeutic candidates.
Flexion Therapeutics (NASDAQ: FLXN) is a
specialty pharmaceutical company focused on the development and
commercialization of novel, local therapies for the treatment of
patients with musculoskeletal conditions, beginning with
osteoarthritis, a very painful degenerative arthritis. With
ZILRETTA, the company’s intra-articular therapy for
osteoarthritis-related knee pain approved and commercially launched
in November, 2017, and another five products in various phases of
development, Flexion’s strategy is to build a robust pipeline of
locally administered therapies to address broad range
musculoskeletal conditions.
Cara Therapeutics (NASDAQ: CARA), a
clinical-stage biotechnology company, is focused on developing and
commercializing new chemical entities designed to fundamentally
change the way acute pain, chronic pain and pruritus (itch) are
managed. The company aims to achieve this objective by developing
new products that selectively target the body’s peripheral kappa
opioid receptors. Cara is developing a proprietary class of product
candidates that target the body’s peripheral nervous system which
has 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.
Pain is a complex phenomenon. The unique way each individual
perceives pain and its severity, how it evolves, and the efficacy
of treatment depend on a constellation of biological and
psychological factors. The companies that successfully develop
opioid-free pharmacological therapeutics to reduce human pain and
suffering should be abundantly rewarded.
For more information on PreveCeutical Medical
Inc., visit PreveCeutical Medical Inc. (CSE: PREV) (OTCQB:
PRVCF) (FSE: 18H)
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