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Promising New Approaches in Pain Management

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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