INOvation-1 phase III trial of INOpulse for pulmonary arterial hypertension confirms action.- Bellerophon Therapeutics.

Bellerophon Therapeutics has presented updated interim results from the Pulmonary Arterial Hypertension (PAH) Phase III trial, INOvation-1 evaluating INOpulse for the treatment of pulmonary arterial hypertension. The interim results from INOvation-1, evaluating INOpulse for the treatment of PAH, verified the INOpulse mechanism of action and support its potential in treating PH-ILD patients.

Specifically, following 16 weeks of blinded therapy, subjects on iNO demonstrated clinically meaningful improvement consistent with currently marketed PAH drugs in the following key areas: Pulmonary vascular resistance (PVR) improved by 75 dyne/sec/cm as compared to placebo, which worsened by 111 dyne/sec/cm; Cardiac output (CO) improved by 0.5 L/min as compared to placebo, which worsened by 0.2 L/min; NT-ProBNP, a peptide biomarker for right ventricular failure, improved by 48 pmol/L compared to placebo, which worsened by 20 pmol/L; Clinically meaningful decline in change in six-minute walk distance (6MWD) (more than 15%) was twice as high in the placebo arm as compared to INOpulse; and finally 6MWD improved 41 meters (mono PAH therapy) and 25 meters (excluding prostanoids).