Bellerophon says DMC recommends stopping Phase 3 INOvation-1 study of INOpulse
Bellerophon Therapeutics announced that the Data Monitoring Committee 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.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, 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. "While we are disappointed in the overall efficacy results of this study, we are encouraged by the positive data in hemodynamics and pleased with the safety and tolerability profile of INOpulse. Over the next few weeks, we intend to further analyze the full data set available to us from this interim analysis in order to determine the next steps in our PAH program. On behalf of everyone at Bellerophon, I would like to thank all of the patients and physicians who participated in the INOvation-1 study," said CEO Fabian Tenenbaum. "Based on the results of our Phase 2 studies in pulmonary hypertension associated with interstitial lung disease and pulmonary hypertension associated with chronic obstructive pulmonary disease, we remain positive regarding the potential of our other INOpulse programs. Unlike PAH, patients with PH-ILD and PH-COPD have underlying lung disease for which systemic vasodilators have been ineffective and there are currently no approved therapies. Our ongoing Phase 2b trial in PH-ILD is progressing well, with top-line results expected around the end of 2018. PH-ILD is a significant unmet medical need which we believe represents a substantial potential market opportunity." Bellerophon has sufficient resources to support its currently planned activities into the first half of 2019.