Neuropathix, Inc. CEO Recaps 2020 Advances and Potential Ahead

Doylestown, Pennsylvania, UNITED STATES


DOYLESTOWN, Pa., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Neuropathix, Inc. (“Neuropathix” or the “Company”) (OTCQB: NPTX), a socially responsible pain management life sciences company, announced today that it has issued a letter to its shareholders providing commentary on the Company’s recent initiatives and corporate updates.

The Company’s Chief Executive Officer, Dean Petkanas, commented:

“As we exited 2019, going into 2020, we had attained significant preclinical milestones in further validating our novel and lead therapeutic compound KLS-13019 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) and our patented active ingredient, Limonenyldihydroxybenzyl Ethoxycarbonyl Azetidine (LEA) for use in our trademarked topical skin care product Atopidine®. Today we believe, more than ever before, that our Company has positioned our lead therapeutic compound KLS-13019 as a very viable candidate for a future human clinical trial program for the treatment of CIPN.

To date there has been and continues to be no FDA-approved drug to treat CIPN and there remains a continued use model for oxycontin and oxycodone to try and treat neuropathic pain. And what remains, regardless of any upside from the use of opioids is the constant threat of a drug abuse model that has only been exacerbated by the negative multiplier effect of SARS-CoV-2, better known as COVID-19.

Moreover, our studies indicate that there is a rationale for KLS-13019 as a dual acting monotherapeutic for use in the CIPN model. We are seeing activity in sodium / calcium regulation for mitochondria dysfunction and receptor activity at the inflammasome. A target involved here in the CIPN model is NLRP3, which is currently the subject of recent big pharmaceutical interest and activity, as well as investment interest from some of Wall Street’s top investment banks. We believe we have uncovered a significant pathway within the peripheral nervous system (PNS) that makes us and KLS-13019 unique to others and their drug candidates who are also focused on NLRP3.

While 2020 was a very challenging year, we nevertheless made our way toward strengthening our foundation and purpose. We are excited for the 2021 campaign and our drive to move KLS-13019 into FDA human clinical trials.”

Highlights of the letter include:

  • Neuropathix uncovering the full potential and mechanism of action to the cache of KLS-13019’s competencies as a potent neuroprotective, anti-inflammatory, non-opioid pain management compound and treatment for CIPN.

  • Expanded global protection of Neuropathix IP portfolio suite of new chemical entities (“NCEs”), including KLS-13019. This includes the Company’s global patent cooperation treaty (PCT) application WIPO/PCT Patent WO2015/106108A2 receiving patent approval in seven prominent pharmaceutical jurisdictions that including the U.S., European Union (16 countries), Australia, Canada, Japan, Russia, and China, with patents currently pending in Brazil and India. The PCT patent includes several other molecules in addition to KLS-13019 and has been filed for the potential to treat diseases associated with free radical mediated stress and oxidative stress including Hepatic Encephalopathy (HE), Parkinson’s disease, Alzheimer’s, Huntington’s disease, traumatic head injury, stroke, epilepsy, neuropathic pain, Chronic Traumatic Encephalopathy (CTE), Post Cardiac Arrest Hypoxic Ischemic Encephalopathy, and Epileptic Encephalopathy.

  • Addition of key pharmaceutical, clinical and executive leadership members to the Company’s Advisory Boards, including Dr. Tage Honoré, PhD, DSc, as the Chairman of Neuropathix scientific advisory board as well as Dr. Daniel Richman, MD, a world renowned pain management clinician. The Company also welcomed Terrence O. Tormey to the Company’s corporate advisory board.

  • Neuropathix has completed the formulation of its topical skin care consumer product Atopidine®, containing the patented novel molecule and key active ingredient Limonenyldihydroxybenzyl Ethoxycarbonyl Azetidine (LEA). Preclinical studies indicate that LEA is a potent antipruritic and anti-inflammatory compound. We believe that Atopidine® can become a premium and marketable product with great potential to address and provide itch and pain relief in a number of personal skin care issues, including eczema and excessive radiation.

  • Participation in the National Institute of Health (NIH) Helping to End Addiction Long-termSM (HEAL) Initiative as well as two NIH grant applications with KLS-13019. One of which is for a Phase 2 grant that follows the Company’s successfully completed NIH – National Institutes on Drug Abuse (NIDA), Phase 1 study grant. The other is a separate NIH HEAL Initiative grant opportunity to consider additional backup compounds to KLS-13019, including selective non-opioid and non-abuse potential new drug candidates, for further preclinical and potential clinical review.

  • Acquisition of pre-clinically validated, potent neuroprotective and anticonvulsant small-molecule drug technology IP Estate, including compounds like AND-302 and AND-383. Exemplification of this technology can be found in the issued US Patent 8,609,849 entitled “Novel Hydroxylated Sulfamides Exhibiting Neuroprotective Action and Their Method of Use.”

  • The Company’s new global patent cooperation treaty (PCT) application WIPO/PCT Patent WO 2020/ 264324 – “Use of Certain Phosphatidylcholines Containing Long Chain Polyunsaturated Fatty Acids (“PUFAs”) as Neuroprotective Agents” (the “PUFA Patent”). With newly discovered science through our extensive research into humulus lupulus (also known as hops) which resulted in a new PCT patent filing for a novel class of neuroprotective compounds including NPTX-204.

  • Commentary on Neuropathix 2021 plans, including further research on its patented molecules with the potential to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA).

To read the Letter to Shareholders in full, please visit: https://neuropathix.com/wp-content/uploads/2021/01/Neuropathix-Inc.-Shareholder-Letter-210124.pdf.

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. 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 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.

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