Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression

标志着第一种被批准用于自杀性双相抑郁症的药物的开发迈出了重要一步

The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter

研究数据库正在清理和锁定；此后不久将进行统计分析和顶线数据

Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.

该研究在主要终点上保持了研究地点和中心评分者之间95%的一致率。没有报告意外的严重不良事件。

Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens

积极的数据和FDA的评论将引发合作伙伴Alvogen和Lotus下一个400万美元的里程碑付款，并承担开发成本；该协议规定了高达3.29亿美元的里程碑付款和青少年中期净销售额的版税

RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx Pharmaceuticals', the 'Company'), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression.  The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter.  As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen.

宾夕法尼亚州拉德诺，2024年3月4日/PRNewswire/--NRx制药公司（纳斯达克：NRXP）（“NRx制药公司”，简称“公司”）是一家临床阶段的生物制药公司，今天宣布，第74位也是最后一位可评估的患者完成了NRx-101的2b/3期研究中的第42天访问，该公司是NMDA拮抗剂D-环丝氨酸和卢拉西酮的专利组合，在抗自杀治疗的双相抑郁症中。正在清理、最终确定和锁定数据库；然后将进行统计分析，随后不久将提供顶行数据。如前所述，该试验的积极数据触发了Alvogen的里程碑付款。

Alvogen will then be responsible for further development and commercialization costs for this program..

阿尔沃根将负责该项目的进一步开发和商业化成本。。

NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it..

NRX-101已被FDA授予突破性治疗指定，快速通道指定，生物标志物支持信以及治疗自杀性双相抑郁的特别协议。它是唯一证明双相抑郁患者自杀意念降低的口服药物，双相抑郁是一种致命疾病，每五名患者中就有一人死于这种疾病。。

'This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting.

据该公司所知，这是首次在门诊对自杀性双相抑郁患者进行临床试验。我们之前的试验测量了NRX-101在医院环境中维持氯胺酮的抗抑郁和抗自杀作用的能力。

These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals.  Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome.

这些临床需求迫切且异常的患者通常被排除在所有先前已知的抗抑郁药物的临床试验之外。NRx制药公司创始人、董事长兼首席科学家乔纳森·贾维特博士说。尽管有些患者的抑郁状况恶化并需要住院治疗（我们尚不知道他们是否服用NRX-101或比较药物），但患者的安全性得以维持，没有试验参与者出现严重的意外不良后果。

Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone,' '.

我们感谢我们的研究人员、诊所、合作伙伴，最重要的是，感谢我们令人惊叹的患者及其家人，感谢他们将这项研究贯穿于这一重要里程碑。

The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS).  As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials..

2b/3期临床试验（www.clinicaltrials.gov NCT 03395392）是一项随机，前瞻性，多中心，双盲研究，比较NRX-101和lurasidone在六周内的疗效。首席研究员是哈佛麻省总医院的安德鲁·尼伦伯格教授。主要疗效终点是MADRS量表测量的抑郁症减少，次要终点是临床总体印象自杀量表（CGI-SS）测量的自杀意念减少。如前所述，治疗依从性和当地评分员与中央评分员评分的一致性超过94%，远高于中枢神经系统试验中通常看到的行业标准。。

Top-line results are expected around the end of this quarter.

预计本季度末左右将公布业绩。

About NRx Pharmaceuticals

关于NRx制药

NRx 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.

NRx 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 and Lotus 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和Lotus合作开发和销售NRx-101，用于治疗自杀性双相抑郁。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 HTX-100 (IV ketamine), through Hope Therapeutics, 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最近宣布计划通过Hope Therapeutics提交HTX-100（静脉注射氯胺酮）治疗自杀性抑郁症的新药申请，该申请基于在美国国立卫生研究院赞助下进行的良好控制的临床试验结果，以及根据数据共享协议从法国卫生当局获得的最新数据。

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。。

About HOPE Therapeutics, Inc.

关于HOPE Therapeutics，Inc。

HOPE Therapeutics, Inc. (www.hopetherapeutics.com)  is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy..

HOPE Therapeutics，Inc.（www.hopetherapeutics.com）是一家专业制药公司，由NRX Pharmaceuticals全资拥有，专注于开发和销售FDA批准的用于治疗急性自杀和抑郁症的静脉注射氯胺酮形式，以及旨在增强和保持NMDA靶向药物治疗临床益处的数字治疗平台。。

Notice Regarding Forward-Looking Statements

关于前瞻性声明的通知

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering.

此处包含的信息包括1934年《证券交易法》第21E节（修订版）和1933年《证券法》第27A节（修订版）所指的前瞻性声明。除其他外，这些声明包括关于拟议公开募股以及募股收益的时间和使用的声明。

Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'may,' 'will,' 'should,' 'would,' 'expect,' 'plan,' 'believe,' 'intend,' 'look forward,' and other similar expressions among others.

前瞻性陈述通常包括具有预测性的陈述，取决于或提及未来的事件或条件，并包括诸如“可能”、“将会”、“应该”、“将会”、“期望”、“计划”、“相信”、“打算”、“展望”和其他类似的表达。

These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

这些报表与未来事件或公司未来财务业绩有关，涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致公司的实际业绩与这些前瞻性报表明示或暗示的任何未来业绩、活动水平、业绩或成就存在重大差异。

You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements.

您不应过度依赖前瞻性陈述，因为它们涉及已知和未知的风险、不确定性和其他因素，在某些情况下，这些因素超出了公司的控制范围，并且可能会对实际结果、活动水平、绩效或成就产生重大影响。

Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K .

任何前瞻性声明都反映了公司对未来事件的当前观点，并受到与公司运营、运营结果、增长战略和流动性有关的这些和其他风险、不确定性和假设的影响。关于公司的更详细信息以及可能影响前瞻性陈述实现的风险因素，请参见公司最新的年度报告10-K表。

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SOURCE NRx Pharmaceuticals, Inc.

SOURCE NRx Pharmaceuticals，股份有限公司。

Company Codes: NASDAQ-NMS:NRXP

公司代码：NASDAQ-NMS：NRXP