- NRx Pharmaceuticals Inc (NASDAQ: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.
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