Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced a major step forward in its program to develop the first cannabinoid-derived pain treatment targeting activation of alpha3 glycine receptors.
When activated, the alpha3 glycine receptor strongly blocks pain signals from being sent to the brain. Kalytera, and its research partner, Beetlebung Pharma Ltd. (“BPL”), have carried out a medicinal chemistry program to identify a novel analogue of cannabidiol (“CBD”) that will block such pain signals via the activation of the alpha3 glycine receptor channel in the spinal cord. To date, no company has introduced into the market an agent specifically targeting this receptor.
Through a series of manipulations of the structure of CBD, a new compound has been invented. This new compound is 40-fold more potent than desoxy-CBD, which is the prototypic alpha3 glycine receptor agonist. The new compound activates only the alpha3 glycine receptor and has no effect on a closely related protein, known as the alpha1 glycine receptor, which may produce unwanted symptoms of muscle weakness.
Based on these findings, Kalytera believes that this novel molecule constitutes the first completely selective alpha3 glycine receptor agonist that can potently activate this critical analgesic pathway without producing complications via the alpha1 glycine receptor pathway.
The high potency of the compound and its total selectivity justify its advancement to human clinical testing as a potential substitute for opioids in the treatment of severe pain. Kalytera is now preparing to evaluate the compound in various animal models in order to select the optimal pain setting in which to conduct human clinical testing.
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 BPL. BPL is an Israeli-based pharmaceutical discovery company focused on cannabinoid-based therapeutics for the treatment of human disease.
“The objective of our program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated. The cannabinoid compound that has been invented has the potential to achieve these goals, and become a next generation pain medication,” stated Robert Farrell, President and CEO of Kalytera. “This novel compound 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 commercial opportunity for Kalytera’s cannabinoid compound for treatment of pain is large. According to a 2016 report by Transparency Market Research, the global pain management therapeutics market is projected to reach USD $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 cannabinoid compound that Kalytera is developing is designed to block pain by a dual action,” said Queensland Brain Institute Professor Joseph Lynch, Ph.D., a world authority on the biology of pain. “First, their cannabinoid triggers the activation of the alpha3 glycine receptor. When activated, the alpha3 glycine receptor strongly 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 be able to maximize the activation of the alpha3 glycine receptor pathway for treatment of intractable pain.”
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.
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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.