The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis. The main questions it aims to answer are:
Does NRX101 help participants resolve UTIs?
Is NRX101 safe for participants with UTIs?
Participants will be seen in a doctor's office approximately 6 times to:
Answer a short 10 item questionnaire.
Review of side effects
Urine tests
Blood draw (about 10 ml or 2 teaspoons)
Review of medications
Review any signs or symptoms of UTI
Vital signs and weight (including blood pressure, heart rate, respiratory rate, and temperature)
Review of medical history
This is an open-label study of NRX101, which means both you and your doctor know what drug you are taking. After the study is completed, researchers will look at the data to see if NRX101 helps participants with complicated UTI's.

Start Date31 Mar 2024

Sponsor / Collaborator

NeuroRx, Inc.

NCT03395392 / CompletedPhase 2/3

A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

Start Date12 May 2022

Sponsor / Collaborator

NeuroRx, Inc.

NCT04990466 / WithdrawnPhase 2/3

A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine

IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.

Start Date30 Sep 2021

Sponsor / Collaborator

NeuroRx, Inc.

100 Clinical Results associated with NeuroRx, Inc.

0 Patents (Medical) associated with NeuroRx, Inc.

Literatures (Medical) associated with NeuroRx, Inc.

01 Oct 2023·International journal of toxicology

NRX-101, a Rapid-Acting Anti-Depressant, Does Not Cause Neurotoxicity Following Ketamine Administration in Preclinical Models

Article

Author: Jordan, William ; Sapko, Michael T. ; Siegel, Richard ; Javitt, Jonathan

Agents that act at the N-methyl-D-aspartate receptor (NMDAR), such as ketamine, have gained increasing attention as rapid-acting antidepressants; however, their use has been limited by potential neurotoxicity. Recent FDA guidance requires a demonstration of safety on histologic parameters prior to the initiation of human studies. D-cycloserine (DCS) is a partial NMDA agonist that, along with lurasidone, is being investigated as a treatment for depression. The current study was designed to investigate the neurologic safety profile of DCS. To this end, female Sprague Dawley rats (n = 106) were randomly divided into 8 study groups. Ketamine was administered via tail vein infusion. DCS and lurasidone were administered via oral gavage in escalating doses to a maximum of 2000 mg/kg DCS. To ascertain toxicity, dose escalation with 3 different doses of D-cycloserine/lurasidone was given in combination with ketamine. MK-801, a known neurotoxic NMDA antagonist, was administered as a positive control. Brain tissue was sectioned and stained with H&E, silver, and Fluoro-Jade B stains. No fatalities were observed in any group. No microscopic abnormalities were found in the brain of animal subjects given ketamine, ketamine followed by DCS/lurasidone, or DCS/lurasidone alone. Neuronal necrosis, as expected, was seen in the MK-801 (positive control) group. We conclude that NRX-101, a fixed-dose combination of DCS/lurasidone, when administered with or without prior infusion of IV ketamine was tolerated and did not induce neurotoxicity, even at supratherapeutic doses of DCS.

01 Apr 2017·NeuroImageQ1 · MEDICINE

Statistical power and prediction accuracy in multisite resting-state fMRI connectivity

Q1 · MEDICINE

ArticleOA

Author: Risterucci, Celine ; Bellec, Pierre ; Orban, Pierre ; Dansereau, Christian ; Benhajali, Yassine ; Arnold, Douglas ; Pich, Emilio Merlo

Connectivity studies using resting-state functional magnetic resonance imaging are increasingly pooling data acquired at multiple sites. While this may allow investigators to speed up recruitment or increase sample size, multisite studies also potentially introduce systematic biases in connectivity measures across sites. In this work, we measure the inter-site effect in connectivity and its impact on our ability to detect individual and group differences. Our study was based on real, as opposed to simulated, multisite fMRI datasets collected in N=345 young, healthy subjects across 8 scanning sites with 3T scanners and heterogeneous scanning protocols, drawn from the 1000 functional connectome project. We first empirically show that typical functional networks were reliably found at the group level in all sites, and that the amplitude of the inter-site effects was small to moderate, with a Cohen's effect size below 0.5 on average across brain connections. We then implemented a series of Monte-Carlo simulations, based on real data, to evaluate the impact of the multisite effects on detection power in statistical tests comparing two groups (with and without the effect) using a general linear model, as well as on the prediction of group labels with a support-vector machine. As a reference, we also implemented the same simulations with fMRI data collected at a single site using an identical sample size. Simulations revealed that using data from heterogeneous sites only slightly decreased our ability to detect changes compared to a monosite study with the GLM, and had a greater impact on prediction accuracy. However, the deleterious effect of multisite data pooling tended to decrease as the total sample size increased, to a point where differences between monosite and multisite simulations were small with N=120 subjects. Taken together, our results support the feasibility of multisite studies in rs-fMRI provided the sample size is large enough.

Antibiotics (Basel, Switzerland)

NRX-101 (D-Cycloserine + Lurasidone) Is Active against Drug-Resistant Urinary Pathogens In Vitro

Article

Author: Sapko, Michael T. ; Panicucci, Riccardo ; Javitt, Jonathan C. ; Manyak, Michael

D-Cycloserine (DCS) is a broad-spectrum antibiotic that is currently FDA-approved to treat tuberculosis (TB) disease and urinary tract infection (UTI). Despite numerous reports showing good clinical efficacy, DCS fell out of favor as a UTI treatment because of its propensity to cause side effects. NRX-101, a fixed-dose combination of DCS and lurasidone, has been awarded Qualified Infectious Disease Product and Fast Track Designation by the FDA. In this study, we tested NRX-101 against the urinary tract pathogens Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter baumannii in cation-adjusted Mueller–Hinton broth (caMHB) and artificial urine media (AUM). Several strains were multidrug resistant. Test compounds were serially diluted in broth/media. Minimum inhibitory concentration (MIC) was defined as the lowest concentration of the test compound at which no bacterial growth was observed. DCS exhibited antibacterial efficacy against all strains tested while lurasidone did not appreciably affect the antibacterial action of DCS in vitro. In AUM, the MICs ranged from 128 to 512 mcg/mL for both DCS and NRX-101. In caMHB, MICs ranged from 8 to 1024 mcg/mL for NRX-101 and 32 to 512 mcg/mL for DCS alone. Our data confirm that DCS has antibacterial activity against reference and drug-resistant urinary pathogens. Furthermore, lurasidone does not interfere with DCS’s antimicrobial action in vitro. These results support the clinical development of NRX-101 as a treatment for complicated urinary tract infections.

153

News (Medical) associated with NeuroRx, Inc.

31 Oct 2024

·ir.nrxpharma.com

NRx Pharmaceuticals to present at The Emerging Growth Conference, discussing update on HOPE Therapeutics

MIAMI, Oct. 31, 2024 (GLOBE NEWSWIRE) -- EmergingGrowth.com a leading independent small cap media portal announces NRx Pharmaceuticals (NASDAQ: NRXP) will appear on the Emerging Growth Conference today in response to multiple requests and investor demand. The Emerging Growth Conference identifies companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long-term growth. Jonathan Javitt, MD, MPH, Founder and Chairman will be discussing its first steps towards acquisition through its HOPE Therapeutics subsidiary of a national network of interventional psychiatry clinics focused on treatment of suicidal depression and PTSD with ketamine, transcranial magnetic stimulation, digital therapeutics, and other therapies that affect the NMDA receptor of the brain. Register Here for the presentation.

Acquisition

23 Oct 2024

·www.globenewswire.com

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) and HOPE Therapeutics, Inc. Announce Participation at the ThinkEquity Conference October 30, 2024

MIAMI, Oct. 23, 2024 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, (“NRx,” the “Company”) and HOPE Therapeutics, Inc., a medical and technology driven company and wholly-owned subsidiary of NRx, today announced they will be featured as a participating in the ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institutional investors, corporate clients, and other industry professionals to highlight groundbreaking innovations and financial strategies. Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx and Co-CEO of Hope, will be presenting at 8:30AM ET on October 30th. Members of the NRx management team will also be holding one-on-one investor meetings throughout the day. Interested investors can register to attend and schedule on-on-one meetings here. The presentation will also be live-streamed at the following link: NRx Events. About NRx Pharmaceuticals, Inc.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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for 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 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. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. About ThinkEquityThinkEquity is a boutique investment bank founded by professionals who have collaborated for over a decade, collectively financing over $50 billion in public and private capital raises, restructurings, and mergers and acquisitions. Past ThinkEquity conferences have featured over 70 company presentations, 700+ attendees, and 500+ one-on-one meetings, providing a valuable platform for companies and investors to connect. To register to attend The ThinkEquity Conference, please follow this link. Notice Regarding Forward-Looking StatementsThe 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. 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. 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. 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. 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 and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: CORPORATE CONTACTS: Jeremy Feffer, LifeSci Advisors, Inc.jfeffer@lifesciadvisors.com Matthew DuffyChief Business Officer, NRx PharmaceuticalsCo-CEO, HOPE Therapeutics, Inc.mduffy@nrxpharma.com

Fast TrackNDA

18 Jun 2024

·www.biospace.com

NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Neuroscience, Information Technology and Medical Technology Veteran to its Board of Directors

Dr. Dennis McBride brings extensive experience in Neuroscience and its interface with Information and Medical Technology Retired at a rank that is the civilian equivalent of a senior flag officer from the United States Navy RADNOR, Pa., June 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has added Dr. Dennis McBride to its Board of Directors. Dr. McBride brings deep experience in Neuroscience, Medical and Information Technology and digital therapeutics to the Company. "I am delighted to welcome Dennis to the Board of NRx. His unique background in both Neuroscience and Medical Technology will be an important asset to the company as we seek to develop more advanced treatments for patients," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "I have worked with Dennis previously on a highly successful digital therapeutic and know the quality he brings to our company." "I am proud to join the Board of NRx at such an exciting time for the company – the opportunities have never been greater in Neuroscience to advance and improve novel therapies," commented Dr. McBride. "I look forward to using my experience to help advance its strategy and further the development of NRx's impressive pipeline of CNS products and leading its initiative in digital therapeutics." Dr. Dennis McBride has led numerous national and international initiatives in neuroscience and its interface with information technology, national security, and medical technology/drug development both within the federal government and in the private sector, three of which are now multi-billion-dollar enterprises. He has formative experience in CNS-focused digital therapeutics, having participated with NRx founders in developing now military-proven digital therapeutic technology for reduction of stress and depression. He was instrumental to the founding of InQTel and other private sector-focused initiatives. Dr. McBride dedicated his Navy career to Aerospace Medicine and ergonomics, during which he served in leadership roles at six nationally-prominent laboratories, including the Defense Advanced Research Projects Agency (DARPA), Naval Aerospace Medical Research Lab, Naval Research Lab, the Office of Naval Research, and the Naval Medical Research Institute. Upon retiring as a highly decorated Navy Captain, he assumed leadership of the Potomac Institute for Policy Studies, where he continues to serve as President Emeritus. He then joined the National Defense University as a Professor to lead the Center for Technology and National Security Policy, completing his term as a Senior Executive-4 (Civilian equivalent to Vice Admiral). Most recently, he served a tour of duty in the Office of the Secretary of Defense. Dr. McBride has served as an adviser to Cabinet Secretaries, US Congressional Committees, and to corporate C-Suite executives. His educational background includes the University of Georgia, Naval Aerospace Medical Institute, the University of Southern California, the London School of Economics, and Harvard Business School, earning a Ph.D. in experimental psychology and four master's degrees. About NRx Pharmaceuticals 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 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 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 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. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. ( ) 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. Notice Regarding Forward-Looking Statements 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. 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. 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. 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. 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 and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: NASDAQ-NMS:NRXP

Executive ChangeFast TrackBreakthrough Therapy

100 Deals associated with NeuroRx, Inc.

100 Translational Medicine associated with NeuroRx, Inc.

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Pipeline

Pipeline Snapshot as of 27 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ketamine Hydrochloride ( NMDA receptor )	Depressive Disorder More	Phase 3
Lurasidone/Cycloserine ( 5-HT1A receptor x 5-HT2A receptor x 5-HT7 receptor x D2 receptor x NMDA receptor x ddlA )	Nociceptive Pain More	Phase 2
IIBR-100 ( SARS-CoV-2 S protein )	COVID-19 More	Discontinued
Aviptadil ( VIPR1 x VIPR2 )	Respiratory Distress Syndrome More	Pending

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