NRx Pharmaceuticals Publishes Shareholder Update Letter

Rhea-AI Summary

NRx Pharmaceuticals announces data sharing agreement for Ketamine study, potential NDA filing in 2024

Positive

• Potential NDA filing for NRX-100 in 2024
• Data support NMDA as a more potent target in Bipolar Depression
• Considerable laboratory evidence supporting a ketamine-like effect with DCS
• SMR Spectroscopy showed comparable effect of DCS and Ketamine on brain glutamate levels

Negative

• None.

• Focus on implications of the recent Data Sharing Agreement relating to a landmark trial of Ketamine in the treatment of Suicidal Depression
• NMDA antagonist highly effective in Bipolar subgroup (p<0.001)

RADNOR, Pa., Sept. 20, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service stay up to date on company's progress here: NRX Email Alerts . (Note: not all updates will be included in a Press Release in the future).

Today's update highlights potential implications of the Company's recent announcement of a Data Sharing Agreement to gain access to the patient level (anonymized) data from a major Ketamine study in France (BMJ 2022; 376 Link).  The key points include:

• Potential NDA filing for NRX-100 in 2024; Breakthrough Therapy Designation previously granted
• Data support NMDA as a more potent target in Bipolar Depression than Major Depressive Disorder
• Review of other published evidence for ketamine-like effect with NRX-101
  • Considerable laboratory evidence supporting a ketamine like effect with DCS
  • MR Spectroscopy showed comparable effect of DCS and Ketamine on brain glutamate levels – a key biomarker in Bipolar Disorder

Please subscribe to the Company's email for future updates.  NRX Email Alerts Not all of these will be the subject of a Press Release in the future.

About NRX-101

NRX-101, a fixed dose combination of D-cycloserine and lurasidone, has been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support from the FDA for Suicidal Treatment Resistant Bipolar Depression (S-TRBD).  Additionally, the product is being developed in chronic pain and PTSD.

Up to 50% of individuals with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. The only FDA-approved treatment for patients with treatment-resistant suicidal bipolar depression remains electroconvulsive therapy.

Conventional antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101 is a patented, oral, fixed dose combination of D-cycloserine and lurasidone, neither of which has shown addiction potential in preclinical models. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from the FDA for the treatment of severe bipolar depression in patients with Acute Suicidal Ideation and Behavior (ASIB) after initial stabilization with ketamine or other effective therapy.

NRX-101 is one of the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as chronic pain, PTSD and other indications, as well as potential use in Urinary Tract Infections (UTI).

About NRx Pharmaceutical
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's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor and is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression (S-TRBD), which includes patients with both acute and sub-acute suicidality, an indication for which the only approved treatment is electroshock therapy. The Company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD, to help bring NRX-101 to a global population of patients with unmet medical need. NRx Pharmaceuticals is currently exploring NRX-101's potential to act as a non-opioid chronic pain treatment option and is continuing to plan to enroll patients in an Israeli-based trial of patients suffering from post-traumatic stress disorder with depression and suicidality.

Cautionary Note Regarding Forward-Looking Statements

This press release 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. 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. Actual results could differ materially from those contemplated by the forward-looking statements. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, as may be supplemented, or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements.

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.

CORPORATE CONTACT
Jeremy Feffer
LifeSci Advisors, Inc.
jfeffer@lifesciadvisors.com

Matthew Duffy
Chief Business Officer
mduffy@nrxpharma.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-publishes-shareholder-update-letter-301932966.html

SOURCE NRx Pharma