The U.S. Food and Drug Administration (FDA) agreed to the Phase 2 study of INOpulse in pulmonary hypertension (PH) patients with interstitial lung disease. This is the third potential treatment application of INOpulse, a device that delivers inhaled nitric oxide, developed by Bellerophon Therapeutics.
In patients with pulmonary hypertension, the pulmonary arteries constrict and their walls become thickened. But inhaled nitric oxide therapy may contribute to vasodilation (the opening of blood vessels in the affected area) and help patients regulate their lung pressure.
Currently, nitric oxide can be administered to ventilated patients in hospitals. But the portable device INOpulse, which is roughly the size of a paperback book, may enable patients to carry it and inhale nitric oxide inside or outside their homes.
Bellerophon’s INOpulse device synchronizes with patients’ breathing patterns, automatically adjusting to ensure consistent nitric oxide delivery to the lungs through a nasal cannula (a flexible tube with two prongs that go into the nostrils). Previous clinical trials have tested the device in patients with pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF) and patients with pulmonary arterial hypertension.
The FDA’s green light for the Phase 2b trial followed the positive results of a Phase 2a study (NCT01728220) testing INOpulse for the treatment of PH-IPF. The findings, presented at the American Thoracic Society (ATS) International Conference on May 21, 2017, showed that INOpulse improves respiratory and exercise capacity in patients with difficult-to-treat PH-IPF.
The new study, called iNO-PF, will also include patients with pulmonary hypertension associated with interstitial lung disease (ILD).
“We are very pleased to have concordance with the FDA on our iNO-PF Phase 2b trial for INOpulse in ILD and to have a finalized plan to move forward with this important trial,” Fabian Tenenbaum, chief executive officer of Bellerophon Therapeutics, said in a press release.
“The proprietary targeted delivery and the dual mode of action of INOpulse may allow it to be used in pulmonary fibrosing diseases where systemic vasodilators have proven to be ineffective,” he added. “The lack of approved therapies for pulmonary hypertension associated with interstitial lung diseases represents a unique opportunity to develop a new therapy in this serious and significant unmet medical need.”
The trial, planned for 2018, will recruit 40 subjects diagnosed with pulmonary fibrosis, half of whom are at intermediate to high risk of pulmonary hypertension. Importantly, the FDA has agreed to a trial design that eliminates the need for right heart catheterization, an invasive procedure that can present significant challenges for potential study participants.