Neuropathix, Inc. Chooses Purisys for Process Optimization and Scale Up of Its Lead Drug Candidate KLS-13019
Neuropathix, Inc. Chooses Purisys for Process Optimization and Scale Up of Its Lead Drug Candidate KLS-13019
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.
賓夕法尼亞州多伊爾斯敦/ACCESSWIRE/2021年11月17日/Neuropathix，Inc.(“Neuropathix”或“公司”)(場外交易市場代碼：NPTX)是一傢俱有社會責任感的生命科學公司，專注於研究和開發治療慢性和急性炎症以及神經性疼痛的非阿片類藥物平臺。該公司今天宣佈，它已選擇聘請Purisys有限責任公司來優化和擴大KLS-13019，以推動公司在2022年進行動物毒性研究的計劃，併為之後的人類臨牀試驗開闢一條道路。
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.
Purisys總部設在佐治亞州雅典，專門從事活性藥物成分(API)、CDMO服務和參考標準/材料的合成製造。Purisys在大麻素相關化合物的合成製造和分析測試方面擁有豐富的經驗。
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.
鑑於普瑞斯在批量合成原料藥生產領域的豐富知識和經驗，以及在合成大麻素製造方面的專業知識，我們相信普瑞斯將能夠在KLS-13019的定製製造中利用這些知識，並管理關鍵的現有商業供應鏈，為KLS-13019的臨牀製造開發一套健壯且可擴展的流程。“。
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).
除其他事項外，該公司的臨牀開發方法要求普里斯公司對目前生產KLS-13019的合成和工藝進行優化。成功的KLS-13019原料藥合成工藝將進行動物毒性研究，並在該公司向美國食品和藥物管理局提交用於預防和逆轉化療引起的周圍神經病(CIPN)的IND時，對該公司的KLS-13019臨牀生產計劃起到核心作用。
"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.
Purisys公司總經理喬什·霍納説：“我們非常高興能與Neuropathix公司合作，為患者帶來像KLS-13019這樣的變革性的新化學物質。Purisys公司在大麻類化學方面的專業知識和經驗可以追溯到15年前，我們將利用這些經驗迅速優化、擴大並提供強大和可靠的化學過程。此外，Purisys公司擁有供應鏈和CMC監管知識，可以支持Neuropathix公司從臨牀前研究到所有IND階段，最終通過NDA批准。”
"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.
他説：“能去雅典真的很好。對我來説，身為希臘裔美國人有點諷刺，但這是完全有道理的。我們與Purisys的旅程始於2015年。我們知道他們在批量合成大麻二醇(CBD)方面的專業知識將改變當時的遊戲規則。因此，當時，我們決定將Purisys高純度、藥用級合成CBD與我們的專利化合物NPTX-204一起放入凝膠膠囊配方中，由Catalent Pharma Solutions進行可行性和穩定性研究。這打開了通向我們今天的大門。最重要的兩點是，它讓我們更接近於向FDA提交計劃中的IND，用於治療CIPN和滿足嚴重的未得到滿足的醫療需求。與Purisys合作，我們知道我們將擁有在美國製造的最高質量保證的原料藥。供應鏈問題見鬼去吧“，Neuropathix首席執行官迪恩·佩特卡納斯(Dean Petkanas)説。
About KLS-13019
關於KLS-13019
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是Neuropathix獲得專利的領先臨牀目標，用於潛在治療一系列神經毒性、神經退行性和神經病理性疼痛障礙，從CIPN開始。
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是一種單一治療的非阿片類大麻衍生物，在臨牀前動物研究中已被證明可以預防和逆轉神經病理性疼痛。
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.
KLS-13019尚未經過美國食品和藥物管理局(FDA)或世界上任何其他醫療機構的審查或批准用於患者。它的安全性和有效性還沒有得到FDA批准的研究的證實。
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.
Neuropathix公司最近從美國國立衞生研究院(NIH)的國家神經疾病和中風研究所(NINDS)獲得了為期三年、價值297萬美元的第二階段STTR研究補助金。為期三年的STTR研究補助金由美國國立衞生研究院旨在加強疼痛管理的療法和技術開發的NIH Hear Initiative(幫助長期戒除成癮)提供資金，並將專門為神經性疼痛KLS-13019的開發提供資金。
About Purisys LLC
關於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.
總部設在美國佐治亞州雅典的Purisys公司是原料藥合同製造和開發服務的領先提供商，包括臨牀階段化合物的定製合成和分析開發服務。Purisys的專業知識包括廣泛的科學和監管知識、最先進的製造技術以及按時交付項目的記錄。Purisys可以開發廣泛的原料藥，包括用於治療各種適應症的臨牀階段化合物，包括心血管、中樞神經系統、精神健康和腫瘤藥物等治療領域。該公司在製藥行業擁有長期、成功的監管記錄，致力於高純度、一致性和合規性。Purisys還擁有一套全面的CDMO產品和強大的參考標準計劃，以支持製藥業向患者提供創新的新療法。
About Neuropathix, Inc.
關於Neuropathix公司
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.
Neuropathix是一家生物製藥公司，專注於研究和開發下一代、對社會負責的消炎、疼痛管理和神經保護療法的流水線，用於治療有重大未得到滿足的醫療需求的患者。在過去的十年中，Neuropathix公司已經發現、開發和申請了以其主要臨牀目標KLS-13019為首的全球知識產權，作為新的治療藥物，旨在預防和逆轉神經性疼痛，減少氧化應激，並起到抗炎神經保護劑的作用。該公司的專利單一治療分子系列專注於治療氧化應激相關疾病、慢性疼痛管理和神經退行性疾病。治療的靶點包括CIPN，一種由有毒化療藥物引起的慢性神經病變；肝性腦病(HE)，一種由大腦中過量的氨和乙醇引起的神經毒性腦-肝疾病；輕度創傷性腦損傷(MTBI)，一種與單次和重複撞擊損傷相關的疾病；以及慢性創傷性腦病(CTE)，一種與職業和業餘運動中高度重複撞擊損傷相關的疾病。Neuropathix公司在賓夕法尼亞州多伊爾斯敦的巴克斯縣賓夕法尼亞生物技術中心進行研究和開發工作。欲瞭解有關Neuropathix的更多信息，請訪問www.uropathix.com和該公司的推特網頁：@uropathix。
Forward-Looking Statements
前瞻性陳述
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.
本新聞稿可能包含某些前瞻性陳述和信息，符合1933年證券法第27A節和1934年證券交易法第21E節的定義，並受這兩節規定的安全港的約束。本新聞稿包含有關預期的未來事件、公司的業務計劃、運營計劃、與普里斯公司的夥伴關係、公司候選藥物的可行性、KLS-13019的臨牀製造和測試計劃、向食品和藥物管理局提交KLS-13019的IND的計劃、KLS-13019的預期益處、公司的狀況和/或財務結果的陳述，這些陳述具有前瞻性，受風險和不確定因素的影響。根據定義，此類前瞻性陳述包含風險和不確定因素。本公司不銷售或分銷任何違反美國受控物質法的產品。
CONTACTS:
聯繫人：
Media Relations:
Thoma Kikis
Chief Communications Officer
P: 917-652-2479
E: thoma@neuropathix.com
www.neuropathix.com
媒體關係：託馬·基基斯(Thoma Kikis)首席傳播官P: 917-652-2479電子郵件：thoma@uropathix.comWww.neuropathix.com
Investor Relations:
Louie Toma
Managing Director
CORE IR
P: 516-222-2560
E: louie@coreir.com
www.coreir.com
投資者關係：路易·託馬常務董事核心紅外光譜P: 516-222-2560電子郵件：Louie@coreir.comWww.coreir.com
Purisys Contact:
Amber Burch
Manager, Technical Business Development
P: 302-660-1176
E: ABurch@purisys.com
www.purisys.com
Purisys聯繫人：琥珀·伯奇技術業務開發部經理P: 302-660-1176電子郵件：aburch@purisys.comWww.purisys.com
SOURCE: Neuropathix, Inc.
資料來源：Neuropathix，Inc.
譯文內容由第三人軟體翻譯。