NRx Pharmaceuticals reports recommendations of DSMB for NRX-101 trial

NRx Pharmaceuticals reported the recommendations of an independent Data Safety Monitoring Board, or DSMB, which reviewed the safety findings of the first fifty enrolled participants in the company’s phase 2 clinical trial of NRX-101 for the treatment of Severe Bipolar Depression and Subacute Suicidal Ideation or Behavior. NRX-101 is a proprietary fixed dose combination of D-cycloserine and lurasidone. It is the only antidepressant currently in clinicals trials for patients with Bipolar Depression with acute or sub-acute suicidality, which also entails an NMDA component, similar to Auvelity and Spravator. 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, or ASIB, study requires that patients first be stabilized in a clinical setting, patients enrolled in this current Phase 2 trial are randomly assigned to NRX-101 or lurasidone – a widely used drug indicated for the treatment of bipolar depression. 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 March 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.