INOpulse fails phase III trial to treat pulmonary arterial hypertension.- Bellerophon Therapeutics.
Bellerophon Therapeutics, Inc.has announced that the Data Monitoring Committee (DMC) has completed its pre-specified interim analysis from the first 75 enrolled subjects completing 16-weeks of treatment in the Phase III INOvation-1 study evaluating INOpulse (nitric oxide delivery system) for the treatment of pulmonary arterial hypertension.
The DMC has recommended that the trial be stopped for futility. INOpulse was well-tolerated and there were no safety concerns that led the DMC to recommend concluding the trial. The data showed improvement in pulmonary vascular resistance, however, the DMC deemed the overall change in 6 minute walk distance, the primary endpoint of the trial, insufficient to support the continuation of the study.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.