Phase 2 Trial to Test INOpulse in Patients with PH and Chronic Obstructive Pulmonary Disease

INOpulse, a nitric oxide delivery device that is being developed by Bellerophon Therapeutics, was approved by health authorities in Belgium to be used in a Phase 2 trial in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The first patient is expected to be enrolled in the third quarter of 2016, and the company intends to report trial results by year’s end.

COPD patients with advanced disease often have low blood-oxygen levels, which may lead to a protective mechanism known as hypoxic vasoconstriction that is meant to increase the amount of oxygen transferred to the blood, but which also may cause pulmonary hypertension. This puts extra strain on the heart, and is associated with increased hospitalization rates, impaired exercise capacity, and decreased life expectancy.

Bellerophon is developing INOpulse to deliver nitric oxide (NO) directly into the lungs of patients with PH-COPD. This molecule is thought to be absorbed by the muscle cells surrounding the pulmonary vessels, helping them to relax and, most likely, reduce a patient’s blood pressure.

“The prognosis of COPD patients with severe PH is very poor and there is currently no approved therapy to treat this condition. We look forward to developing a therapy for this serious unmet medical need,” Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, said in a press release.

The study builds on the results of a previous Phase 2a trial conducted by Bellerophon, as well as a trial developed by researchers at the Department of Respiratory Medicine at the University Hospital Antwerp, showing that acute doses of INOpulse induced vasodilation in PH-COPD patients.

Ten PH-COPD patients on long-term oxygen therapy are expected to enroll in the open-label Phase 2 study, evaluating INOpulse potential on exercise capacity. Patients will receive NO (30 mcg/kg/hour) for four weeks, after which a high-resolution computed tomography (HRCT) scan will be used to measure vasodilation in their pulmonary arteries. A key secondary endpoint at four weeks is 6-minute walking distance (6MWD; a test to measure exercise capacity). As follow-up, patients will be evaluated two weeks after the last administration of NO.

Bellerophon’s INOpulse is also under development for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF).