Kalytera Initiates Program to Develop a Novel Cannabinoid-Based Compound for Treatment of Acute and Chronic
Pain
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced
that it has begun development of a novel cannabinoid-based compound for the treatment of acute and chronic pain. Patents for this
compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an exclusive, worldwide license for this
compound from Beetlebung Pharma, Ltd., an Israeli-based pharmaceutical discovery company focused on cannabinoid-based therapeutics
for the treatment of human disease ("BPL").
Use of cannabinoids in the treatment of pain is supported by data from many studies. According to results of a systemic
review of randomized controlled trials published in the Journal of Neuroimmune Pharmacology, cannabinoids have
demonstrated significant analgesic effects and were well tolerated.
Kalytera’s compound consists of a cannabinoid conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is
already approved for treatment of pain. This cannabinoid/naproxen conjugate has potential to become a next generation pain
medication, and, based on the potentially complementary methods of action of the cannabinoid and naproxen, there is reason to
believe these molecules may have a synergistic effect in treatment of pain, as well as a superior safety profile compared with
opioid analgesics.
“We are pleased and excited to announce this new program in treatment of pain,” said Robert Farrell, President and CEO of
Kalytera. "The promise of this novel compound is that the two active agents, the cannabinoid and naproxen, may provide effective
pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have also found a
way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth,
short surgical procedures, and post-operative pain care.”
The objective of Kalytera’s new program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will
be safe and well tolerated. The cannabinoid component will act as a cannabinoid receptor agonist, targeting the alpha3 glycine pain
receptor in the spinal cord, and the naproxen component will block the synthesis of the pain-inducing molecule PGE2. Although the
initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation.
The commercial opportunity for Kalytera’s cannabinoid/naproxen conjugate is large. According to a 2016 report by Transparency
Market Research, the global pain management therapeutics market is projected to reach $83 billion by 2024. Current treatments for
pain mainly include non-steroidal anti-inflammatory drugs ("NSAIDs"), such as naproxen, for mild to moderate pain, and opioids,
such as morphine, for moderate to severe and chronic pain. Kalytera believes that its product will be suitable for mild to severe
pain, without the risks of respiratory suppression and dependence associated with opioid analgesics.
“The potential synergy between this unique cannabinoid and naproxen in the treatment of pain holds great promise,” said
Queensland Brain Institute Professor Joseph Lynch, Ph.D., a world authority on the biology of pain. “The cannabinoid analog
that Kalytera is developing is designed to block pain by a dual action. First, their cannabinoid triggers the activation of a
specialized protein in the spinal cord known as the alpha3 glycine receptor. To date, no company has introduced into the market an
agent specifically targeting this receptor. When activated, the alpha3 glycine receptor potently blocks pain signals from being
sent to the brain. Second, Kalytera has engineered its compound to insure the alpha3 glycine receptor is activated by a second
mechanism. This is achieved by attaching naproxen to the cannabinoid in a manner that allows it to detach in the spinal cord and
block the synthesis of the pain-inducing prostaglandin molecule PGE2. The combination of naproxen with the cannabinoid is crucial
because PGE2 is known to shut down the alpha3 glycine receptor pathway. By combining both molecules into a single drug, Kalytera
has designed a next generation pain medication that should maximize the activation of the alpha3 glycine receptor pathway for
treatment of intractable pain.”
The program for treatment of pain that the Company has announced today is a first step in the expansion and diversification of
its cannabinoid-based product development portfolio.
“The initiation of this program is an important first step in our overall strategy to expand and diversify,” stated Ron
Erickson, Kalytera’s Chairman. “We have a late-stage clinical program with cannabidiol (“CBD”) in the prevention and
treatment of graft versus host disease, and today we have added a program in the treatment of pain. The pain market is demanding
safer and effective treatments, and we believe our novel cannabinoid/naproxen conjugate may meet that need. In addition, we are
evaluating a number of other unique and novel cannabinoid conjugates with potential to address unmet medical needs in other
markets.”
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. ("Kalytera") is pioneering the development of a next generation of cannabinoid therapeutics.
Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a
leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial
focus on graft versus host disease and the treatment of acute and chronic pain.
About Beetlebung Pharma
Beetlebung Pharma Limited (BPL), an Israeli affiliate of SG International, focuses on the discovery and development of
novel cannabis-related pharmaceutical therapeutics. SG International (the “Salzman Group”) provides clinical management and other
services to Kalytera in connection with Kalytera’s programs evaluating CBD in the prevention and treatment of graft versus host
disease. BPL has invented a broad range of cannabinoid new chemical entities in therapeutic areas encompassing pain, inflammation,
autoimmunity, ischemia-reperfusion injury, and central nervous system injury. BPL is also active in the development of novel
formulations of existing cannabinoids, terpenes, and sesquiterpenes that may contribute to the entourage effect. To provide
scientific support for its pharmaceutical programs, BPL carries out biological research on terpenoid cell signaling and
pharmacology in its basic research laboratories. In an effort to lower cost of goods of complex cannabinoid molecules intended for
pharmaceutical use, BPL has invented a series of more efficient synthetic routes for manufacture of cannabidiol and related
cannabinoids and is conducting process scale-up research in its pilot plant facilities to advance these products to the stage of
commercial manufacturing. BPL is a private, closely held corporation.
Cautionary Statements
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release may contain certain forward-looking information and statements ("forward-looking information") within the
meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in
respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives
and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue",
"estimate", "forecasts" and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking
information. Actual results and developments may differ materially from those contemplated by these statements depending on, among
other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable. Kalytera undertakes no
obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating
results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press
release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future
events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera's
control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is
made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to
update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
Kalytera Therapeutics, Inc.
Robert Farrell
President, CEO
(888) 861-2008
info@kalytera.co
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