“The U.S. Food and Drug Administration approved the design of a Phase 2b trial of INOpulse, a device that delivers nitric oxide, as a treatment for patients with pulmonary hypertension associated with lung disease.
INOpulse’s developer, Bellerophon Therapeutics, said the sign-off came after a meeting with the FDA in June. In addition to the Phase 2b design, the meeting covered positive results of the completed Phase 2a iNO-PF trial [using Functional Respiratory Imaging (FRI)] (NCT01457781). That study involved INOpulse’s use in patients with PH associated with idiopathic pulmonary fibrosis.
INOpulse widens narrowed blood vessels, allowing more blood flow to the heart. The Phase 2a trial achieved its primary objective of widening vessels by increasing blood vessel volume 15.3 percent. The trial also showed a significant association between the blood-vessel widening — or vasodilation — that INOpulse provides and improved ventilation, or movement of air in and out of the lungs.”
Figure 1. Changes in blood vessel volume after administration of iNO: Green indicates a positive regional increase in blood vessel volume, red indicates a reduction in blood vessel volume