Bellerophon Announces Results of Interim Analysis of Phase 3 INOvation-1 Study Evaluating INOpulse for Treatment of Pulmonary Arterial Hypertension

Bellerophon Therapeutics (Nasdaq:BLPH) a clinical-stage biotherapeutics company, today 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 3 INOvation-1 study evaluating INOpulse® for the treatment of pulmonary arterial hypertension (PAH).

As quoted in the press release:

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.

As previously agreed upon with the U.S. Food and Drug Administration (FDA), the pre-specified interim analysis was conducted by the DMC after half of the planned subjects completed 16-weeks of blinded treatment.  The DMC considered four potential recommendations relative to its review of the data: stopping the trial early for efficacy, continuing to enroll the study as planned, increasing the targeted enrollment size if the original design was slightly underpowered, and stopping the study for futility or safety concerns.

Click here to read the full press release.