DOYLESTOWN, PA / ACCESSWIRE / January 18, 2022 / Neuropathix, Inc. ("Neuropathix" or the "Company") (OTCQB:NPTX), a socially responsible pain management life sciences company, today announces that the Company has been issued Indian Patent IN201617027528 specific to its global patent known as WO2015/106108A2 titled, "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy" (the "PCT Patent").
Under the PCT Patent, Neuropathix novel therapeutic compounds have the potential to target diseases that include neuropathic pain, traumatic head injury, stroke, Chronic Traumatic Encephalopathy (CTE), Post Cardiac Arrest Hypoxic Ischemic Encephalopathy, Epileptic Encephalopathy, and neurodegenerative diseases such as Parkinson's disease, Alzheimer's, Huntington's disease, and amyotrophic lateral sclerosis (ALS). With the PCT Patent, along with the Company's novel lead drug candidate, KLS-13019, and its other novel therapeutic agents Neuropathix now has near global coverage in the top pharmaceutical markets in the world.
With the addition of India, Neuropathix now has eight (8) prominent pharmaceutical jurisdictions that include the U.S., European Union (16 countries), Canada, Australia, Japan, Russia, and China, with Brazil currently pending.
The global market for prescription drug sales are expected to see a compound annual growth rate (CAGR) of 8.9% from 2018 to 2026. According to the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. India's domestic pharmaceutical market is estimated at US$ 42 billion in 2021 and likely to reach US$ 65 billion by 2024 and further expand to reach ~US$ 120-130 billion by 2030.
"India is a vibrant and significant pharmaceutical marketplace that is home to multibillion dollar companies like Sun Pharmaceutical Industries, Dr. Reddy's Labs, Alembic Pharmaceuticals and others. This patent award in India furthers our standing as a leader and pioneer in the discovery and preclinical testing of novel globally patented synthetic analogues of cannabidiol (CBD). We believe that the general consensus regarding our position in the market will ultimately turn to the fact that our IP has taken the best that nature has offered which is CBD, and simply made it orders of magnitude better. That is the very essence of drug discovery and pointedly in the now emerging field of cannabinoid therapeutics. We believe that this acknowledgment starts with patent awards from scientifically advanced markets like India. We are grateful for this award and hope to continue to add to our IP estate in the very near future," said Dean Petkanas, CEO of Neuropathix.
KLS-13019 is the Company's leading candidate to treat chemotherapy-induced peripheral neuropathy (CIPN), a disorder which currently has no FDA-approved drugs for treatment. Current off-label prescription of opioids, a leading agitator of overdose deaths and addiction, is the current model of treatment.
KLS-13019 leads Neuropathix intellectual property portfolio of novel monotherapeutic molecules ("KLS Family") which are capable of acting as neuroprotective agents, and have the potential to treat a range of diseases, including nervous system, oxidative stress, inflammation, mitochondrial dysfunction and neurodegenerative disorders. It is the Company's leading candidate to treat chemotherapy induced peripheral neuropathy (CIPN), a disorder which currently has no FDA approved drugs for treatment. Current off-label prescription of opioids, a leading agitator of overdose deaths and addiction, is the current model of treatment.
The PCT Patent grants in the Additional Territories mark the twenty-five (25th) patent that Neuropathix has received to date worldwide. Of the twenty-five (25) patents issued to the Company, two (2) are U.S. patents, and twenty-three (23) are foreign patents. The two (2) U.S. patents are:
- U.S. Patent 9,611,213 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy;" and
- U.S. Patent 10,004,722 "Method for treating hepatic encephalopathy or a disease associated with free radical mediate stress and oxidative stress with novel functionalized 1,3-benzene diols"
The twenty-three (23) foreign patents claim priority to Neuropathix original 2014 U.S. filing through international application PCT/US2015/010827, which was published as WO2015/106108A2 titled, "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy."
Of the twenty-three (23) foreign patents, sixteen (16) of them are granted for the PCT Patent in the European territories of AT, BE, CH, DE, DK, ES, FR, GB, IE, IT, LI, LU, MC NL, SE and TR. The remaining seven (7) foreign patents are:
- Japanese Patent JP6486950B2"Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy"
- Russian Patent RU2676475C2 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy"
- Chinese Patent CN106456573B "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy"
- Canadian Patent CA2936506A1 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy"
- Australian Patent AU2015204609B2 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy"
- European Patent EP3094318B1 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy," and
- Indian Patent IN201617027528 "Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy."
Neuropathix also has national phase patent application based on the PCT Patent application pending in Brazil.
The Company was recently awarded a three-year $2.97 million Phase 2 STTR Study Grant by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). The three-year STTR Study Grant is funded through the NIH HEAL Initiative (Helping End Addiction Long-term) for Development of Therapies and Technologies Directed at Enhanced Pain Management and will provide funding specifically in the Development of KLS-13019 for Neuropathic Pain. The Notice of Award R42NS120548 sets forth the funding allocation of $977,054 in year 1, $991,944 in year 2 and $1,001,774 in year 3.
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.
About KLS-13019
KLS-13019 is Neuropathix patented lead clinical target for the potential treatment of a range of 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 CIPN and the Global Neuropathic Pain Market
Chemotherapy induced peripheral neuropathy (CIPN) is the most common side effect of chemotherapy drugs and is defined as a progressive, enduring and often irreversible condition featuring neuropathic pain, numbness, tingling, and sensitivity to cold in the hands and feet, sometimes progressing to the arms and legs. The global neuropathic pain market is forecast to reach $9.8 billion USD by 2027 at a CAGR of 5.6% between 2020 and 2027. Increasing prevalence of cancer is expected to propel growth of the global neuropathic pain market over the forecast period.
About the Global Opioids Drug Market
The global opioids drug market is expected to reach $33.78 billion USD by 2028, at a CAGR of 2.56% from the forecast period 2019-2028. Opioids are mainly used in cancer pain management and end-stage diseases in which painkilling care is required. The rising prevalence of cancer, high demand for pain therapeutics in the treatment of chronic pain, regulatory approvals and launches of innovative drug formulations, and increasing approval rate of abuse-deterrent formulations of opioid drugs are major driving factors of the global opioids drug market. The arrival of the coronavirus disease (COVID-19) pandemic has provided an unanticipated haven for the already formidable opioid epidemic.
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:
Media Relations:
Thoma Kikis
Chief Communications Officer
P: 917-652-2479
E: thoma@neuropathix.com
www.neuropathix.com
Investor Relations:
Louie Toma
Managing Director
CORE IR
P: 516-222-2560
E: louie@coreir.com
www.coreir.com
SOURCE: Neuropathix, Inc.
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