NRx Pharmaceuticals Provides Business Update and Reports Second Quarter 2022 Results Focusing on Reactivation & Advancement of its Psychiatry Franchise

Company to Host Conference Call and Webcast August 15, 2022, at 8:30am ET

RADNOR, Pa., Aug. 15, 2022  /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the second quarter of 2022 and provided a business and clinical update.

"During our second quarter, we reactivated clinical development in our psychiatry franchise around our lead compound, NRX-101. NRX-101 has been awarded Breakthrough Therapy designation and a Special Protocol Agreement for severe bipolar depression with acute suicidal ideation and behavior (ASIB) by the U.S. Food and Drug Administration (FDA), said Stephen Willard, Chief Executive Officer of the Company. "We anticipate initiation of the study in severe bipolar depression with acute suicidal ideation and behavior (ASIB) to commence at the end of 2022 or at the beginning of 2023.

During this quarter, we commenced enrollment in our Phase 2 trial of NRX-101 in patients with Bipolar Depression and Sub-Acute Suicidal Ideation & Behavior (SSIB)", said Willard. "The purpose of this trial is to expand our potential indication from bipolar depression in patients with acute suicidality to the significantly larger population of patients with bipolar depression and sub-acute suicidality, who are being treated in the ambulatory setting.  We are evaluating the adequacy of the protocol to support approval for the treatment of the larger SSIB population.  We project a readout of the data from this trial by the end of the year or early Q1 of next year".

"We expect to release commercial-stage material of NRX-101 in the coming weeks. This material will be used in our phase 2b/3 trial of NRX-101 for severe bipolar depression in patients with acute suicidal ideation & behavior (ASIB) under the FDA Special Protocol Agreement, which we expect to start in Q4," said Mr. Willard.

Many approved drugs for bipolar depression have warning labels for increased risk of suicide.  To our knowledge, NRX-101 is the only oral antidepressant in the bipolar segment that targets patients with active suicidality, which typically is an exclusion criterion in clinical studies of depression and PTSD.  Phase 2 STABIL-B trial1 data of NRX-101 demonstrated a significant reduction in both depression and suicidality compared to standard therapy in acutely suicidal patients who were first stabilized with ketamine. We have released non-clinical findings demonstrating that, unlike ketamine, both components in NRX-101 have not shown potential for addiction and are not neurotoxic (i.e., do not cause death of brain cells in FDA-required assays).2

In Q2, we repatriated the manufacture of NRX-101 drug supply to North Carolina and are currently manufacturing clinical supplies for P3 as part of the commercial readiness program.

Our psychiatry franchise builds on a strong scientific and intellectual property foundation with 47 granted patents and 43 pending applications around the world. Our focus is to address this major unmet medical need for which the only currently approved treatment is electroshock therapy.  It is estimated that 50% of individuals with bipolar disorder attempt suicide over their lifetime.  We believe NRX-101 is a potentially life-saving medicine that could change the treatment paradigm for individuals with bipolar depression that are also experiencing suicidality." 

We expect to evaluate the options for ZYESAMI® in COVID-19 Respiratory Failure and other lung disorders once we receive the full data set from NIH towards the end of Q3 or early Q4 and have conducted our own analysis.

Although we are not funding additional clinical trials of ZYESAMI® at this time, we have completed manufacture of phase 3/commercial ready ZYESAMI®.  We also received an independent assessment of chest X-ray data from a sub-study that included a subgroup of approximately 80 patients that had survived to day 10 in our Phase 2b/3 study of ZYESAMI®. The sub-study showed a statistically significant improvement in chest X-rays using the RALES score in patients with COVID-19 respiratory failure, compared to a worsening in patients treated with placebo (P