Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that it has invented a novel first-in-class cannabinoid molecule, designated KAL-1816, that strongly and selectively binds with and activates the alpha3 glycine pain receptor.
Activation of the alpha3 glycine receptor shuts down pain transmission in inflammatory conditions, such as arthritis, colitis, and sciatica.
“Today’s announcement is a milestone in Kalytera’s search for a breakthrough cannabinoid analgesic that will operate via a wholly new pathway,” stated Robert Farrell, Kalytera’s President and CEO.
KAL-1816 is the first cannabinoid pharmaceutical designed to specifically target the alpha3 glycine pain receptor, and is at least 40-fold more potent than desoxy-cannabidiol, which is a prototypic alpha3 glycine receptor agonist. It was invented after two years of medicinal chemistry work done by Kalytera’s research team, during which dozens of novel cannabinoid analogues were invented and screened.
KAL-1816 selectively activates only the alpha3 glycine receptor and has no effect on the closely related alpha1 glycine receptor, which, when activated, may produce unwanted symptoms of muscle weakness. Accordingly, KAL-1816 is expected to provide pain relief for inflammatory conditions without inducing safety concerns, and may offer hope of pain relief to those who do not respond to or cannot tolerate the side effects of conventional analgesics.
“Based on our findings, we believe that KAL-1816 constitutes the first completely selective alpha3 glycine receptor agonist that can potently activate this critical pain relief pathway without producing complications via the alpha1 glycine receptor pathway,” stated Farrell. “The objective of our program has been to develop a potent, non-psychotropic, oral analgesic for the treatment of pain that will be safe and well tolerated. We believe that KAL-1816 has the potential to achieve these goals, and to become a next generation pain medication. This novel molecule may provide effective pain relief, without the risks of addiction or respiratory suppression that exist with opioid analgesics.”
In preparation for future clinical trials, Kalytera will now advance KAL-1816 into a series of IND-enabling studies to be conducted over the next year. These investigations will include in vivo efficacy studies, pharmacokinetic studies, and safety studies, all of which will be required by the FDA for commencement of a Phase 1 human clinical study in the treatment of pain.
A provisional patent protecting composition of matter and method of use for KAL-1816 has been filed and is expected to convert to a full standard worldwide patent filing later this year. Kalytera has obtained an exclusive, worldwide license for this compound and its related analogues from Beetlebung Pharmaceuticals Ltd. (“BPL”). BPL is an Israeli pharmaceutical discovery company focused on cannabinoid-based therapeutics for the treatment of human disease.
The commercial opportunity for Kalytera’s KAL-1816 molecule 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.
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.