Bellerophon Therapeutics, Inc announced that enrollment in its Phase 3 INOvation-1 study evaluating INOpulse® in patients with pulmonary arterial hypertension (PAH) now exceeds 100 patients, representing more than half of the anticipated enrollment.  As previously agreed with the U.S. Food and Drug Administration (FDA), an interim analysis of this trial will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase.  The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the trial size should be increased.  The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study toward the end of 2018. The INOpulse PAH Phase 3 program consists of two studies, the INOvation-1 study, and a confirmatory randomized withdrawal study with approximately 40 patients who will cross over from the INOvation-1 study. The INOvation-1 study is evaluating the safety and efficacy of the INOpulse delivery system for the treatment of patients with PAH on long-term oxygen treatment (LTOT).  The INOpulse delivery system utilizes a proprietary technology to deliver pulsatile inhaled nitric oxide (iNO), allowing for use in a portable chronic setting.  The primary endpoint of the study is Six Minute Walk Distance (6MWD), with Time to Clinical Worsening as a secondary endpoint. The INOvation-1 trial includes an interim analysis after approximately half the patients have completed the 16-week blinded phase on either iNO at a dose of 75 mcg/kg IBW/hr (iNO75) or placebo.  The interim analysis will be conducted by the independent Data Monitoring Committee, which will provide the Company with one of four predetermined decisions, including allowing the trial to be stopped early if efficacy has been demonstrated, continuing the trial to the planned size, increasing the trial size to reach a threshold of conditional powering, or halting the trial for futility. As agreed with the FDA, the INOvation-1 and withdrawal studies can serve as the two adequate and well-controlled studies required to support a New Drug Application filing for INOpulse in PAH subjects on LTOT.