Monitoring Board Recommends NRx Pharma's Suicidal Bipolar Depression Study To Continue Enrollment

NRx Pharmaceuticals Inc NRXP reported that the independent Data Safety Monitoring Board (DSMB) reviewed the safety and efficacy findings of the first 50 enrolled participants in its clinical trial of NRX-101 for Severe Bipolar Depression and Subacute Suicidal Ideation or Behavior.
NRX-101 is a proprietary fixed-dose combination of D-cycloserine and lurasidone.
The people enrolled in this trial had bipolar depression and suicidal thoughts.
The DSMB found no futility signal at this stage of the trial.
Similarly, no safety signals were identified in association with NRX-101, and the DSMB recommended that enrollment in the trial continue as planned.
The DSMB will continue to monitor safety and efficacy in the trial.
The company has upgraded the ongoing trial to a phase 2b/3 trial whose results may be used in the future registrational filing, should the primary endpoint be met.
Topline data from this trial in the fourth quarter of 2023.
In the Type B meeting conducted with the FDA, the company was guided to explore the use of NRX-101 in this broader population of patients who may benefit from NRX-101 without prior use of ketamine.
The company plans to discuss the path to approval in this population of people with Suicidal Treatment-Resistant Bipolar Depression in the planned Comprehensive Breakthrough Therapy Meeting with the FDA that is planned for Q2 2023.
Price Action: NRXP shares are up 1.40% at $0.74 on the last check Monday.