DOYLESTOWN, PA / ACCESSWIRE / November 17, 2021 / Neuropathix, Inc. (“Neuropathix” or the “Company”) (OTCQB:NPTX), a socially responsible life sciences company focused on the research and development of a non-opioid platform of therapeutics to treat chronic and acute inflammation, and neuropathic pain, announced today that it has chosen to engage Purisys LLC to optimize and scale up KLS-13019 as the Company moves forward with its plans for animal toxicity studies in 2022, and a path towards human clinical trials thereafter.
Purisys is based in Athens, Georgia, and specializes in the synthetic manufacture of Active Pharmaceutical Ingredients (APIs), CDMO services, and reference standards/materials. Purisys has extensive experience in the synthetic manufacture and analytical testing of cannabinoid related compounds.
Because of the extent of Purisys’ knowledge and experience in the field of producing bulk synthetic APIs as well as its well documented expertise in the manufacture of synthetic cannabinoids, we believe Purisys will be able to leverage this knowledge in the custom manufacturing of KLS-13019, as well as manage a critical existing commercial supply chain, to develop a robust and scalable process for the clinical manufacturing of KLS-13019.
The Company’s clinical development approach calls for, among other things, the optimization by Purisys of the current synthesis and process of producing KLS-13019. A successful bulk synthetic API process for KLS-13019 will enable animal toxicity studies and be central to the Company’s clinical manufacturing plans of KLS-13019 when it files its IND with the FDA for the treatment of the prevention and reversal of chemotherapy induced peripheral neuropathy (CIPN).
“We are very excited to partner with Neuropathix to potentially bring transformational, new chemical entities like KLS-13019 to patients. Purisys’ expertise and experience in cannabinoid chemistry extends back 15+ years and we will use that experience to rapidly optimize, scale and deliver a robust and reliable chemical process. Additionally, Purisys has the supply chain and CMC regulatory knowledge to support Neuropathix from preclinical studies through all IND stages, ultimately through NDA approval,” said Josh Hoerner, General Manager of Purisys.
“It’s really nice to be going to Athens. It’s sort of ironic for me being Hellenic American, but it makes perfect sense. Our journey with Purisys began back in 2015. We knew their expertise in the bulk synthesis of cannabidiol (CBD) would be a game changer then. So back then, we decided to put the Purisys highly purified, pharmaceutical grade synthetic CBD together with our proprietary compound NPTX-204, into a gel capsule formulation under a feasibility and stability study at Catalent Pharma Solutions. This opened the door to where we are today. The two greatest parts of it all, is that it brings us closer to filing our planned IND with the FDA for treating CIPN and meeting serious unmet medical needs. And working with Purisys, we know we will have the highest quality assured API that is made right here in the United States of America. Supply chain problems be damned”, said Dean Petkanas, CEO of Neuropathix.
KLS-13019 is Neuropathix patented lead clinical target for the potential treatment of a range of neurotoxic, neurodegenerative and neuropathic pain disorders, beginning with CIPN.
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.
Neuropathix was recently awarded a three-year $2.97 million Phase 2 STTR Study Grant from 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.
About Purisys LLC
Headquartered in Athens, Georgia, USA Purisys is a leading provider of API contract manufacturing and development services including custom synthesis and analytical development services for clinical stage compounds. Purisys’ expertise includes extensive scientific and regulatory know-how, state-of-the-art manufacturing technologies and a track record of delivering projects on time. Purisys can develop a broad range of APIs, including clinical stage compounds used to treat a variety of indications including therapeutic areas such as cardiovascular, central nervous system, mental health, and oncological drugs. The company has a long-term, successful regulatory track record in the pharmaceutical industry with a commitment to high purity, consistency, and compliance. Purisys also has a comprehensive set of CDMO offerings and a robust reference standard program to support the pharmaceutical industry’s delivery of innovative new therapies to patients.
About Neuropathix, Inc.
Neuropathix is a biopharmaceutical company focused on the research and development of a pipeline of next generation, socially responsible anti-inflammatory, 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 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.
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, partnership with Purisys, the viability of the Company’s drug candidates, clinical manufacturing and testing plans for KLS-13019, plans to file an IND with the FDA for KLS-13019, 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.
SOURCE: Neuropathix, Inc.