Summary:

• Independent Data Safety Monitoring Board (DSMB) reviewed the safety findings of the first 50 enrolled participants in the Company’s Phase 2 study in patients with Bipolar Depression and Subacute Suicidality (not requiring hospitalization)
  • The DSMB recommended that enrollment in the trial continue as planned and identified no drug-related Serious Adverse Events or other safety issues of concern
• The Company anticipates that the DSMB will examine unblinded study data in Mar 2023 to assess the study for safety, potential futility, and conditional power
• The Company views today’s safety finding as important because this is the first time, to the Company’s knowledge that patients with Bipolar Depression and Subacute Suicidal Ideation and Behavior have been actively recruited into an outpatient clinical trial of a novel NMDA based antidepressant
• Trial Details: NCT03395392, Phase 2; n=70; Patients with Bipolar Depression and sub-acute suicidality and behaviour; Recruiting; NRX-101 BID vs. Lurasidone BID; Primary outcome: MADRS-10 total score; PCD: Dec 2022; Location: US
  • Unlike the Company’s previously completed Phase 2 study which enrolled acutely suicidal patients, this current Phase 2 study addresses the needs of the much larger population of patients with Bipolar Depression and sub-acute levels of suicidality, i.e., not requiring stabilization in a clinical setting, who are cared for in the outpatient setting, including doctors’ offices, community mental health centers, and outpatient clinics
  • The Company’s Bipolar Depression with Acute Suicidal Ideation or Behavior (ASIB) study requires that patients first be stabilized in a clinical setting. However, patients enrolled in this Phase 2 trial are randomly assigned to NRX-101 or Lurasidone

 “…We appreciate the DSMB’s work in guiding us to continue this trial.  We are now exploring a registrational path forward to serve this much larger group of individuals with Bipolar Depression and subacute levels of suicidality. This population of patients encompasses a much larger proportion of the approximately 7 Mn individuals in America who have Bipolar Disease, half of whom are reported to attempt suicide at some point in their lives” said Stephen Willard, CEO