NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA review

经FDA审查，NRX-101已显示出对耐药性尿路病原体的有效活性

QIDP designation grants Priority Review and an additional 5 years of additional product exclusivity

QIDP指定授予优先审查和额外5年的额外产品专有权

3 million Americans develop complicated Urinary Tract Infection (cUTI) each year at a cost that ranges from $4497 to $17,431 with a high rate of antibiotic resistance and need for inpatient hospitalization1

每年有300万美国人患有复杂的尿路感染，费用从4497美元到17431美元不等，抗生素耐药率很高，需要住院治疗1

Unlike many advanced-generation antibiotics, NRX-101 is not contra-indicated in sulfa and penicillin allergic patients and is not believed to disrupt the normal intestinal microbiome, potentially leading to reduced risk of C. difficile infection

与许多先进一代抗生素不同，NRX-101在磺胺和青霉素过敏患者中并不禁忌，也不被认为会破坏正常的肠道微生物群，从而可能降低艰难梭菌感染的风险

Data have been accepted for posting on biorxiv and are under review at a peer-reviewed journal3

数据已被接受发布在biorxiv上，并正在同行评审的期刊上进行审查3

RADNOR, Pa., Jan. 16, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx Pharmaceuticals', the 'Company'), a clinical-stage biopharmaceutical company, today announced that it has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis.  Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.  The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.

宾夕法尼亚州拉德诺，2024年1月16日/PRNewswire/--NRx制药公司（纳斯达克股票代码：NRXP）（“NRx制药公司”，以下简称“公司”）是一家临床阶段的生物制药公司，今天宣布它已获得美国FDA关于NRx-101治疗复杂性尿路感染（cUTI）和肾盂肾炎的合格传染病产品（QIDP）和快速通道指定。收到QIDP指定后，NRX-101本已强大的知识产权地位将获得优先审查，关键是另外五年的数据排他性。FDA还为cUTI授予了NRX-101快速通道名称，这还允许滚动提交该公司的新药申请。

In addition to the marketplace protections conferred by QIDP designation in the US, NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. The data that formed the basis of FDA's QIDP approval have been submitted for publication. On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101..

除了美国QIDP指定授予的市场保护外，NRx在所有主要全球市场中至少在2033年对NRx-101拥有物质专利保护。构成FDA QIDP批准基础的数据已提交出版。在此基础上，NRx正在寻找积极参与泌尿科、传染病和/或妇女健康的合作伙伴，以实现NRx-101的商业化。。

The active antibiotic ingredient of NRX-101 is D-cycloserine (DCS) that was developed as an antibiotic in the 1950's and used worldwide for the treatment of tuberculosis. However, it fell out of favor with the development of trimethoprim/sulfa and various penicillins, cephalosporins, and tetracyclines, in part because of the CNS effects associated with DCS-induced blockade of the brain's NMDA receptor.

NRX-101的活性抗生素成分是D-环丝氨酸（DCS），它是20世纪50年代开发的一种抗生素，在世界范围内用于治疗结核病。然而，随着甲氧苄啶/磺胺和各种青霉素，头孢菌素和四环素的发展，它不再受欢迎，部分原因是与DC诱导的大脑NMDA受体阻断相关的中枢神经系统效应。

In the course of its CNS research, NRx pharmaceuticals has demonstrated that small doses of lurasidone counteract those CNS effects, potentially providing a new therapeutic life to DCS as an antibiotic. Over the ensuing decades, increased antibiotic resistance has rendered standard treatments for UTI ineffective in many cases and today 3 million Americans suffer from cUTI requiring increasingly toxic antibiotics, increasingly frequent intravenous therapy, and increased need for hospital admission.1.

在其中枢神经系统研究过程中，NRx pharmaceuticals已经证明，小剂量的lurasidone可以抵消这些中枢神经系统的作用，可能为DC作为抗生素提供新的治疗生命。在随后的几十年中，抗生素耐药性的增加使得UTI的标准治疗在许多情况下无效，今天有300万美国人患有CUI，需要越来越多的毒性抗生素，越来越频繁的静脉治疗，以及越来越多的住院需求。

Because DCS has the unique property of being highly concentrated, unmetabolized, in the urine with oral administration, the Company believes, and previous literature has suggested that DCS may effectively treat, and therefore help prevent, the need for intravenous and inpatient treatment of cUTI. Moreover, because DCS is rapidly absorbed and excreted in the urine, the Company is optimistic that NRX-101 will have a minimal tendency to disrupt the microbiome of the intestine and which can lead to secondary Clostridium difficile infection.  C.

由于DC具有口服给药在尿液中高度浓缩，不代谢的独特特性，该公司认为，以前的文献表明DC可以有效治疗，因此有助于预防静脉和住院治疗cUTI的需要。此外，由于DC在尿液中迅速吸收和排泄，该公司乐观地认为NRX-101破坏肠道微生物组的趋势最小，并可能导致继发性艰难梭菌感染。C。

diff associated colitis doubles hospital mortality and costs the American healthcare system up to $1.6 billion each year.2  Additionally, DCS has no known association with C. diff or with pulmonary fibrosis, a rare, lethal condition that has been associated with macrolide (tetracycline family) antibiotics..

diff相关性结肠炎使医院死亡率翻了一番，每年给美国医疗保健系统带来的成本高达16亿美元。2此外，DC与艰难梭菌或肺纤维化没有已知的关联，肺纤维化是一种罕见的致命疾病，与大环内酯类（四环素家族）抗生素有关。。

'When we embarked on the development of NRX-101 for treating bipolar depression, we did not imagine that it would develop a new utility as a potentially lifesaving antibiotic. However, the antibiotics we have relied upon for decades are increasingly failing to control resistant pathogens and those that are able to do so are increasingly toxic.

“当我们开始开发用于治疗双相抑郁症的NRX-101时，我们没有想到它会开发出一种新的实用性，作为一种潜在的挽救生命的抗生素。然而，我们几十年来所依赖的抗生素越来越无法控制耐药病原体，而能够控制耐药病原体的抗生素毒性也越来越大。

NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis. These conditions impact 3 million Americans annually and can carry significant co-morbidities, including sepsis and death,' said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals.' Whereas the 12 million Americans who contract uncomplicated UTI each year can expect rapid relief from well-known antibiotics, those who contract cUTI frequently require intravenous therapy, and hospitalization, with frequent serious side effects'.

NRx感谢美国FDA迅速授予针对cUTI和肾盂肾炎的QIDP称号。NRx制药公司创始人、董事长兼首席科学家乔纳森·贾维特（JonathanJavitt）博士说，这些疾病每年影响300万美国人，并可能导致严重的合并症，包括败血症和死亡尽管每年有1200万美国人患有不复杂的UTI，但可以从众所周知的抗生素中迅速缓解，而那些患有CUI的人经常需要静脉治疗和住院治疗，并经常产生严重的副作用。

Dr. Michael Manyak, noted Professor of Urology and former Global Thought Leader for Glaxo SmithKline's urology business added 'As a Urologist, I am excited about the potential availability of NRX-101 for patients suffering from cUTI; this is a very serious condition in desperate need of new treatment options.

著名泌尿学教授、葛兰素史克泌尿学业务前全球思想领袖迈克尔·曼雅克博士补充道：“作为一名泌尿科医生，我对NRX-101可能用于患有cUTI的患者感到兴奋；这是一种非常严重的情况，迫切需要新的治疗选择。

Receipt of QIDP and Fast Track should make NRX-101 even more attractive to potential partners in this multi-billion-dollar market.' Dr. Manyak serves as NRx's Medical Thought Leader for urology..

收到QIDP和Fast Track将使NRX-101对这个数十亿美元市场的潜在合作伙伴更有吸引力。”Manyak博士是NRx泌尿科医学思想的领导者。。

The data presented to the FDA have now been accepted for posting on the biorxiv pre-print server and are under review by a peer-reviewed journal.3

提交给FDA的数据现已被接受发布在biorxiv预打印服务器上，并正在接受同行评审期刊的审查。3

About NRx PharmaceuticalsNRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.

关于NRx PharmaceuticalsNRx Pharmaceuticals是一家临床阶段的生物制药公司，基于其NMDA平台开发治疗药物，用于治疗中枢神经系统疾病，特别是自杀性双相抑郁，慢性疼痛和创伤后应激障碍。该公司正在开发NRX-101，这是一种FDA指定的用于抗自杀治疗的双相抑郁和慢性疼痛的研究性突破疗法。

NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI..

NRx与Alvogen Pharmaceuticals合作开发和销售NRx-101，用于治疗自杀性双相抑郁症。NRX-101还具有作为慢性疼痛的非阿片类药物治疗以及复杂UTI治疗的潜力。。

NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement.

NRx最近宣布计划根据美国国立卫生研究院（National Institutes of Health）赞助下进行的控制良好的临床试验结果，以及根据数据共享协议获得许可的法国卫生部门新获得的数据，提交氯胺酮治疗自杀性抑郁症的新药申请。

NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality..

NRx被美国FDA授予氯胺酮（NRx-100）开发快速通道指定，作为治疗急性自杀患者方案的一部分。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This announcement of NRx Pharmaceuticals, Inc. includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals.

NRx Pharmaceuticals，Inc.的本公告包括1995年《美国私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”，其中可能包括但不限于有关我们的财务前景、产品开发、业务前景以及市场和行业趋势和条件的声明，以及公司的战略、计划、目标和目标。

These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. .

这些前瞻性陈述基于对公司管理层的当前信念、期望、估计、预测和预测，以及公司管理层做出的假设和目前可获得的信息。。

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above..

无论是由于新信息、未来事件还是其他原因，公司都没有义务修改任何前瞻性声明。因此，您不应依赖任何前瞻性声明，所有前瞻性声明均参考上述警示声明。。

1 Lodise TP, et. al. Open Forum Infectious Diseases  https://doi.org/10.1093/ofid/ofac3072 Drozd EM, et. al.  Mortality, Hospital Costs, Payments, and Readmissions Associated With Clostridium difficile Infection DOI: 10.1097/IPC.00000000000002993 https://doi.org/10.1101/2024.01.14.575572

1 Lodise TP等人，公开论坛传染病https://doi.org/10.1093/ofid/ofac3072Drozd EM等人。与艰难梭菌感染相关的死亡率，住院费用，付款和再入院率DOI:10.1097/IPC。0000000000000 2993https://doi.org/10.1101/2024.01.14.575572

SOURCE NRx Pharmaceuticals

来源NRx Pharmaceuticals