Bellerophon announces FDA agreement on INOpulse Phase 2b study design
Bellerophon announced agreement with the FDA on the Phase 2 study design for INOpulse in pulmonary hypertension associated with Interstitial Lung Disease, or ILD. The company met with the FDA in June 2017 to present positive results from its recently completed Phase 2a study in idiopathic pulmonary fibrosis, or IPF, and to review clinical plans for its Phase 2b trial, entitled iNO-PF, in IPF as well as other pulmonary fibrosing diseases within ILD. Subsequently, the Agency has accepted the company's proposed Phase 2b study design as well as an Investigational New Drug, or IND, application to assess the effect of INOpulse on patients at both low and high risk for pulmonary hypertension associated with pulmonary fibrosis. The FDA recognized the dual mode of action of vasodilation and ventilation/perfusion matching of pulsed iNO therapy, which the Company believes can provide a clinically important benefit to a wide range of patients, including those that may not exhibit signs of pulmonary hypertension at rest.