NeuroRx

NRx is a clinical-stage pharmaceutical company that is developing ZYESAMI (aviptadil acetate) for COVID-19 and NRX-101, the first oral therapeutic for the treatment of Acute Suicidal Behavior/Ideation (ASIB) in Bipolar Disorder. In an FDA phase 2b/3 clinical trial, ZYESAMI demonstrated statistically significant increased survival at 60 days, statistically significant increased likelihood of being alive and free of respiratory failure, and 11 days shorter median hospitalization, compared to placebo. ZYESAMI is based on 50 years of research, pioneered by Prof. Sami Said, on the role of Vasoactive Intestinal Peptide in preventing and treating acute lung injury by protecting the Type II cell in the lung. The company is built upon 30 years of basic science and clinical expertise in understanding the role of the brain’s N-methyl-D-aspartate (NMDA) receptor in regulating human thought processes in general and in regulating depression and suicidality. NeuroRx’s investigational treatment approach begins with a single dose of ketamine, an FDA-approved anesthetic, followed by approximately six weeks of daily oral NRX-101. NRX-101 is being developed as a rapid-onset and sustained treatment for acute suicidal crisis associated with bipolar depression. NRX-101 combines D-cycloserine, an N-methyl-D-aspartate (NMDA) receptor modulator; and lurasidone, a 5-HT2a receptor antagonist. Peer-reviewed and published results from two Phase II clinical studies demonstrate a significant decline in symptoms of depression and suicidality following administration of D-cycloserine. Findings from one of these studies found that bipolar patients who were already receiving a 5-HT2a antagonist demonstrated more than a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation when ketamine and D-cycloserine were added to their treatment regimen. Side effects for patients in a P2a combination study of D-cycloserine and 5HT2a included mild sedation, headaches and hypomania