Neuropathix, Inc. Highlights Positive Preclinical Study Results on Lead Drug Candidate KLS-13019

Rhea-AI Summary

Neuropathix (OTCQB:NPTX) announced promising preclinical data demonstrating that its cannabinoid-derived candidate KLS-13019 effectively prevents and reverses chemotherapy-induced peripheral neuropathy (CIPN), outperforming cannabidiol (CBD). Conducted at Temple University, the studies showed KLS-13019 could reverse CIPN-related pain while CBD could not. This discovery, supported by a $2.97 million NIH HEAL grant, positions KLS-13019 for potential IND filing and underscores its low risk for dependency. The global neuropathic pain market is projected to grow from $6.3 billion in 2019 to $9.8 billion by 2027.

Positive

• KLS-13019 showed potential in both preventing and reversing CIPN, exceeding CBD's capabilities.
• The study received funding from a significant $2.97 million grant by the NIH HEAL initiative.
• KLS-13019 operates without binding to opioid receptors, suggesting low dependency risk.
• The growth forecast of the neuropathic pain market highlights a promising commercial opportunity for KLS-13019.

Negative

• None.

Published Preclinical Data Shows KLS-13019 More Effective Than Cannabidiol (CBD) in Prevention, Reversal of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

DOYLESTOWN, PA / ACCESSWIRE / April 13, 2022 / Neuropathix, Inc. ("Neuropathix" or the "Company") (OTCQB:NPTX), a socially responsible, pioneering life-sciences company devoted to addressing the opioid crisis, highlighted today positive preclinical data published in the British Journal of Pharmacology. The publication centered on pre-clinical research for its proprietary, cannabinoid-derived analog KLS-13019 showing both the prevention and reversal of chemotherapy-induced peripheral neuropathy (CIPN). The pre-clinical studies in the animal model indicated that KLS-13019, like CBD, prevented the development of CIPN. However, KLS-13019 was able to reverse the effects of CIPN, whereas CBD could not.

The studies, which took place at the Center for Substance Abuse Research at the Lewis Katz School of Medicine at Temple University, aimed to characterize the behavioral pharmacological effects of KLS-13019 in comparison to CBD and morphine in mouse models for the treatment of CIPN. Over the course of several weeks, nine unique experiments took place where researchers introduced mice to a pure form of CBD, morphine or KLS-13019, then observed their effects on the mechanical sensitivity of the mice. Key findings from the studies showed that while CBD and KLS-13019 were both effective in preventing the development of pain associated with CIPN, KLS-13019 was also able to reverse CIPN-related pain - while CBD proved ineffective in doing so. Even more noteworthy, results from the studies revealed that KLS-13019 did not bind to opioid receptors in the brain, meaning it holds a very low risk for chemical dependency.

"Following our recent grant award from the National Institute of Health - National Institute of Neurological Disorders and Stroke (NIH-NINDS), under the HEAL initiative, these results are leading us down the path towards and IND filing in the future and worth highlighting," said Dean Petkanas, CEO of Neuropathix.

"Pain of all kinds continues to be one of the largest unmet need areas in medicine. Other than opioids, which have a strong risk for dependency and do not address the underlying cause of neuropathic pain, effective treatments are limited with a very small number of companies working on alternative treatments. As I noted in my recent shareholder letter, I believe this is due to the social backlash that opioid manufactures are facing, paired with the complexity of treating generalized pain. This is why we have taken our novel lead drug candidate into research and development of an important and potentially life altering indication of CIPN. We believe that a successful safety study under a Phase I clinical trial can begin to open other doors that involve inflammatory processes in the field of treating neuropathic pain. While the current data regarding KLS-13019 is preclinical, the results are overwhelmingly positive and gives us a great deal of optimism for the future of our lead drug candidate.

Additional information from the study published in the British Journal of Pharmacology note, among other things, that "these studies demonstrate that like CBD, KLS-13019 can prevent the development of mechanical sensitivity following paclitaxel administration in mice, including following oral administration. Because KLS-13019, based on our previous data, binds to fewer biological targets, these findings can bring us closer to identifying molecular mechanisms shared by CBD and KLS-13019, which represent viable treatment targets for the prevention of the development of CIPN. While prevention of CIPN represents a significant unmet medical need, so does the treatment of existing CIPN for thousands of cancer survivors."

Petkanas added: "I am constantly asked about our clinical progress, and we felt it important to continue to point to the study published in the British Journal of Pharmacology as it tells you what direction we are heading. In addition to the publication in the BJOP, we also focus on the $2.97 million NIH-NINDS HEAL grant award, the summary review from highly respected peer reviewing scientists and the impact score of 20 that they provided. All tolled we have to be excited about the prospects for our technology. As we move towards the clinic, our next steps include drug discrimination, animal tox and chemistry, manufacturing, and controls. As we move the chains down field, we will continue to update our investors and the scientific community on our progress in near future."

The global neuropathic pain market was valued at US$ 6.3 billion in 2019 and is forecasted to reach US$ 9.8 billion by 2027 at a CAGR of 5.6% between 2020 and 2027. The increasing prevalence of cancer is expected to propel growth of the global neuropathic pain market over the forecasted period. The global opioids drug market is expected to reach US$ 31 billion by 2027, at a CAGR of 2.5% from the forecasted period of 2020-2027.

Research reported in this publication was supported by the National Institute Of Neurological Disorders And Stroke (NINDS) of the National Institutes of Health (NIH) under Award Number R42NS120548.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About KLS-13019

KLS-13019 is Neuropathix patented lead clinical compound for the potential treatment of a range of inflammatatory, neurodegenerative and neuropathic pain disorders, beginning with chemotherapy-induced peripheral neuropathy (CIPN). KLS-13019 is a monotherapeutic non-opioid cannabinoid derivative that has been shown to prevent and reverse neuropathic pain in pre-clinical animal studies. KLS-13019 has not been reviewed or approved for patient use by the U.S. Food and Drug Administration (FDA) or any other healthcare authority in the world. Its safety and efficacy have not been confirmed by FDA-approved research.

About Neuropathix, Inc.

Neuropathix is a biopharmaceutical company focused on the research and development of a pipeline of next generation, socially responsible pain management and neuroprotective therapeutics to treat patients with significant unmet medical needs. Over the past ten years, Neuropathix has discovered, developed, and patented a global intellectual property estate, led by its lead clinical target, KLS-13019, as novel, new therapeutic agents designed to prevent and reverse neuropathic pain, reduce oxidative stress, and act as anti-inflammatory neuroprotectants. The Company's family of patented monotherapeutic molecules focuses on treating oxidative stress-related diseases, chronic pain management, and neurodegenerative disorders. The therapeutic targets include chemotherapy-induced peripheral neuropathy (CIPN), a chronic neuropathy caused by toxic chemotherapeutic agents; hepatic encephalopathy (HE), a neurotoxic brain-liver disorder caused by excessive concentrations of ammonia and ethanol in the brain; mild traumatic brain injury (mTBI), a disorder associated with single and repetitive impact injuries; and chronic traumatic encephalopathy (CTE), a disease associated with highly repetitive impact injuries in professional and amateur sports. Neuropathix conducts its research and development efforts at the Pennsylvania Biotechnology Center of Bucks County in Doylestown, PA. For more information about Neuropathix, visit www.neuropathix.com and the Company's Twitter page at @neuropathix.

Forward-Looking Statements

This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and is subject to the Safe Harbor created by those sections. This press release contains statements about expected future events, the Company's business plan, plan of operations, the viability of the Company's drug candidates, the targeted beneficial effects of KLS-13019, the Company's position, and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements, by definition, involve risks and uncertainties. The Company does not sell or distribute any products that are in violation of the United States Controlled Substances Act.

CONTACTS:

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SOURCE: Neuropathix, Inc.

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FAQ

What are the results of the KLS-13019 study by Neuropathix?

The study demonstrated that KLS-13019 effectively prevents and reverses chemotherapy-induced peripheral neuropathy (CIPN), unlike CBD which only prevents its development.

What is the significance of the NIH grant for Neuropathix?

The $2.97 million NIH HEAL grant supports the development of KLS-13019, facilitating further research and potential IND filing.

How does KLS-13019 compare to CBD in treating CIPN?

KLS-13019 not only prevents CIPN but also reverses its effects, while CBD has only been shown to prevent pain development.

What is the market potential for KLS-13019?

The global neuropathic pain market is expected to grow from $6.3 billion in 2019 to $9.8 billion by 2027, presenting significant commercial opportunities for KLS-13019.

What are the next steps for Neuropathix after the study?

Neuropathix plans to conduct further research including drug discrimination, animal toxicity studies, and chemistry manufacturing controls to progress KLS-13019 toward clinical trials.