NRx Pharmaceuticals, Inc. (NRXP) reported that the independent Data Safety Monitoring Board reviewed the safety and efficacy findings of the first fifty enrolled participants in the company's clinical trial of NRX-101 for the treatment of Severe Bipolar Depression and Subacute Suicidal Ideation or Behavior. The company said the DSMB found no futility signal at this stage of the trial. Also, no safety signals were identified. The DSMB recommended that enrollment in the trial continue as planned.
Based on the DSMB findings, the company has upgraded the ongoing trial to a phase 2b/3 trial whose results may be used in a future registrational filing, should the primary endpoint be met. The company expects top-line data from this trial in the fourth quarter of 2023.
NRX-101 is a fixed dose combination of D-cycloserine and lurasidone.
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