The option agreement grants NLS Pharmaceutics Ltd. the exclusive option to in-license all of Aexon Labs' assets for the potential treatment of narcolepsy and other neuro-degenerative disorders, and all future indications
Exclusive option agreement accesses global rights to multiple highly selective Orexin-1 / Orexin-2 receptor agonists, unique compounds designed for specificity, acting multiple pathways involved in the pathophysiology of narcolepsy and other central disorders of hypersomnolence
Additional targets include Cathepsin-H inhibition, sigma-1 receptor agonist, DAT and NET reuptake inhibition, addressing neurotransmission, neuroprotection and neuroinflammation
First patent application filed at the end of 2022 for orexin receptors agonists for treating or preventing neurological diseases and psychiatric disorders including narcolepsy
NLS continues to strengthen its neuroscience pipeline in sleep medicine with a unique and holistic approach to central disorders of hypersomnolence and neurodegenerative disorders franchise
ZÜRICH, SWITZERLAND / ACCESSWIRE / December 1, 2023 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system ("CNS") disorders, today announced that NLS has entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company ("Aexon Labs"), under which NLS may acquire global development and commercialization rights to Aexon Labs' Dual Orexin Receptor Agonists platform, new molecular entities, highly selective dual oral orexin-1 and orexin-2 receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders such as Parkinson's and Alzheimer's disease. This option agreement represents a potentially leading next-generation, first-in-class, oral, dual orexin receptor agonist (AEX-2) that is expected to address high unmet medical needs and has shown promising results in pre-clinical in vitro assays. Aexon Labs has plans to initiate clinical development, including Phase 1 First-in-Human and Phase 1b Proof-of-Concept (POC) studies, as early as 2024.
The transaction will be structured as an exclusive worldwide license for the development and commercialization by NLS of the Aexon Labs' compounds and their derivatives. Under the terms of the option agreement, NLS must exercise its option by no later than March 31, 2024. NLS will pay Aexon Labs an upfront payment of $30,000 for the option exclusivity, and $170,000 upon execution of the definitive agreement to exercise the option. In addition, Aexon Labs will receive 15% of all proceeds earned by NLS in any future sub-licensing agreements which include upfront payments, regulatory milestones, commercial milestones and royalties earned during the first three years of commercialization in the U.S. and in the EU. Royalties will be payable, on a country-by-country basis, from the date of first commercial sale of a product in a given country until the date of patent expiry or the entry of a generic version of the product in such country.
NLS will be the sole party responsible for the design and execution of the research and development plan, for the conduct and management of the preclinical as well as clinical studies, and for the interactions with the U.S. Food and Drug Administration and/or any other regulatory agency. NLS will pay all costs associated with executing and completing those studies, as well as those associated with the preparation and submission of a new drug application. NLS will pay for all studies in all indications and regulatory filings in the U.S. as well as outside of the U.S.
Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, is the president and founder of Aexon Labs, and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive position at Aexon Labs.
Mr. Zwyer said, "I believe the potential acquisition of this novel and unique platform which consists of over 300 compounds, bridges the present to the future treatment of sleep disorders as well as other neuro-degenerative disorders. These new compounds, in addition to our current pipeline, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia, long-COVID and chronic fatigue syndrome, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases will further complement and strengthen our hypersomnia franchise."
Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer's disease.
About Narcolepsy
Narcolepsy is a life-long sleep disorder caused by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus, characterized by excessive daytime sleepiness, cataplexy and rapid eye movement sleep abnormalities, and is tightly associated with human leukocyte antigen HLA-DQB1*06:02. Other predisposing factors for narcolepsy are associations with a polymorphism in the T-cell receptor alpha and beta genes, whose products recognize antigens presented by human leukocyte antigens (HLA) molecules, and Cathepsin H (CTSH).
About NLS Pharmaceutics Ltd.
NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit .
About Aexon Labs, Inc.
Aexon Labs is conducting leading edge research on new compounds to address unmet needs in neurodegenerative disorders, defined by the breakdown of neurons over time. Alzheimer's, Parkinson's, Huntington's, Narcolepsy and Amyotrophic Lateral Sclerosis are just a few examples of brain disorders that have no cure. Current treatments do not address the root cause of each disorder and often lack therapeutical effectiveness and safety for these neurological disorders.
期權協議授予NLS Pharmacetics Ltd.許可Aexon Labs所有資產的獨家選擇權,用於發作性睡病和其他神經退行性疾病以及所有未來適應症的潛在治療
獨家期權協議可獲得多種高度選擇性的 Orexin-1 /Orexin-2 受體激動劑的全球權利,這些獨特的化合物專爲特異性而設計,起作用的多種途徑參與發作性睡病和其他中樞性睡眠過度疾病的病理生理學
其他靶標包括抑制組織蛋白酶-H、sigma-1 受體激動劑、DAT 和 NET 再攝取抑制,解決神經傳遞、神經保護和神經炎症
2022 年底首次申請用於治療或預防神經系統疾病和精神疾病(包括髮作性睡病)的食慾素受體激動劑專利
NLS繼續通過對中樞性睡眠過度疾病和神經退行性疾病特許經營權的獨特而全面的方法來加強其在睡眠醫學領域的神經科學管道
瑞士蘇黎世/ACCESSWIRE /2023 年 12 月 1 日/NLS 製藥有限公司(納斯達克股票代碼:NLSP)(納斯達克股票代碼:NLSPW)(“NLS” 或 “公司”)是一家瑞士臨床階段的生物製藥公司,專注於爲罕見和複雜的中樞神經系統(“CNS”)患者發現和開發創新療法,今天宣佈,NLS已加入與美國私營公司Aexon Labs, Inc.(“Aexon Labs”)簽訂的全球獨家期權協議,根據該協議,NLS可以收購Aexon Labs Dual的全球開發和商業化權Orexin 受體激動劑平台、新的分子實體、高選擇性的雙重口服 orexin-1 和 orexin-2 受體激動劑(OX1R 和 OX2R),可能應用於發作性睡病和特發性睡眠過度以及帕金森氏症和阿爾茨海默氏病等神經退行性疾病的治療。該期權協議代表了潛在的下一代同類首創口服雙食慾素受體激動劑(AEX-2),有望滿足大量未得到滿足的醫療需求,並在臨床前體外分析中顯示出令人鼓舞的結果。Aexon Labs計劃最早在2024年啓動臨床開發,包括1期首次人體試驗和1b期概念驗證(POC)研究。
該交易將構成NLS對Aexon Labs化合物及其衍生物進行開發和商業化的全球獨家許可。根據期權協議的條款,NLS必須在2024年3月31日之前行使期權。NLS將向Aexon Labs支付3萬美元的期權排他性預付款,並在執行行使期權的最終協議後向Aexon Labs支付17萬美元。此外,Aexon Labs將獲得NLS在未來任何分許可協議中獲得的所有收益的15%,其中包括預付款、監管里程碑、商業里程碑以及在美國和歐盟商業化的前三年中獲得的特許權使用費。特許權使用費將按國家逐一支付,從產品在給定國家首次商業銷售之日起,到專利到期或該產品的仿製藥進入該國家之日爲止。
NLS將是唯一負責設計和執行研發計劃、進行和管理臨床前和臨床研究以及與美國食品藥品監督管理局和/或任何其他監管機構互動的一方。NLS將支付與執行和完成這些研究有關的所有費用,以及與準備和提交新藥申請相關的費用。NLS將爲美國和美國以外的所有適應症和監管文件中的所有研究付費。
埃裏克·科諾法爾醫學博士,根據兼職諮詢協議在NLS擔任首席科學官,他是Aexon Labs的總裁兼創始人,擁有Aexon Labs59%的股份。NLS首席執行官亞歷山大·茲威爾擁有Aexon Labs35%的股份。Zwyer 先生沒有在 Aexon Labs 擔任董事會或行政職務。
Zwyer先生說:“我相信,這個由300多種化合物組成的新穎而獨特的平台的潛在收購將爲睡眠障礙以及其他神經退行性疾病的現在與未來的治療搭建橋樑。這些新化合物,加上我們目前的產品線,包括用於治療發作性睡病的Mazindol ER,以及專注於特發性睡眠增多、COVID 長期和慢性疲勞綜合徵的 NLS-4,以及針對克萊因-萊文綜合徵和神經退行性疾病的 NLS-11,將進一步補充和加強我們的睡眠過度專營權。”
食慾素受體通路在許多生理過程中起着至關重要的調節作用,研究表明,食慾素受體通路參與神經系統疾病的病理過程,例如發作性睡病、抑鬱症、缺血性中風、吸毒成癮和阿爾茨海默氏病。
關於發作性睡病
發作性睡病是一種終身睡眠障礙,由自身免疫介導的下丘腦中產生食慾素的神經元流失引起,其特徵是白天過度嗜睡、猝死和眼動過快的睡眠異常,與人類白細胞抗原 HLA-DQB1* 06:02 密切相關。發作性睡病的其他誘發因素包括與T細胞受體α和β基因的多態性有關,其產物可識別人類白細胞抗原(HLA)分子和組織蛋白酶H(CTSH)呈現的抗原。
關於 NLS 製藥有限公司
NLS是一家處於發展階段的全球生物製藥公司,與世界一流的合作伙伴和國際知名的科學家合作,專注於爲醫療需求未得到滿足的罕見和複雜中樞神經系統疾病患者發現和開發創新療法。NLS總部位於瑞士,成立於2015年,由經驗豐富的管理團隊領導,他們在開發和商業化候選產品方面有着良好的記錄。欲了解更多信息,請訪問。
關於 Aexon Labs, Inc.
Aexon Labs正在對新化合物進行前沿研究,以滿足神經退行性疾病中未得到滿足的需求,神經退行性疾病的定義是隨着時間的推移神經元的分解。阿爾茨海默氏症、帕金森氏症、亨廷頓氏症、發作性睡病和肌萎縮性側索硬化症只是無法治癒的腦部疾病的幾個例子。目前的治療方法無法解決每種疾病的根本原因,並且通常缺乏針對這些神經系統疾病的治療效果和安全性。