INOpulse is a nitric oxide delivery system under development by Bellerophon Therapeutics. The device is being tested as a treatment for patients with chronic obstructive pulmonary disease (COPD) with associated pulmonary hypertension (PH), or COPD-PH.

How INOpulse works

The active substance delivered by INOpulse is inhaled nitric oxide (iNO). NO is naturally produced by the lining of blood vessels as a vasodilator, a compound that acts to relax the smooth muscle controlling the diameter of arteries, causing them to dilate or open.

In COPD patients, the body can trigger a protective mechanism called hypoxic vasoconstriction to try to maximize the intake of oxygen into the blood. This narrows the blood vessels in regions where the air sacs (alveoli) in the lungs have been damaged and are not receiving enough oxygen, redirecting blood flow to the healthy regions. However, this mechanism can result in an increase in pulmonary artery pressure, leading to the development of PH.

INOpulse is designed as a portable device to ensure a constant and appropriate dose of gaseous nitric oxide throughout the day. It aims to deliver a short pulse of iNO targeted at the ventilated functioning sections of the lung. As iNO is quickly deactivated, it is thought to only open the blood vessels in the targeted healthy sections of the lung. This promotes increased blood flow and gas exchange in these regions without affecting the protective mechanisms at work in other lung regions.

The device is small, light-weight, and battery-powered. This is to allow patients to easily carry it around inside and outside of the home.

INOpulse in clinical trials

INOpulse is currently in Phase 2 clinical trials.

An initial randomized, placebo-controlled, and open-label Phase 2 study  was completed in Austria in June 2014. In total, 32 COPD-PH patients were randomly assigned either an oxygen placebo (n=17) or oxygen with pulsed iNO (n=15) for three months. No treatment-assocıated adverse events were observed after three months, and treated patients showed both a decrease in pulmonary arterial pressures and an improvement in cardiac output. Another Phase 2 trial (NCT01728220), a dose-confirming study on patients with COPD-PH, was completed in July 2014 .

A Phase 1 trial (NCT03135860) is currently assessing the benefits of INOpulse on the exercise capacity of COPD-PH  patients on long-term oxygen therapy. It is an open-label, randomized, placebo-controlled two-part study with 10 patients with confirmed COPD and PH, and is still enrolling people at its test site in Belgium. Bellerophon Therapeutics announced that the trial has produced positive results so far at the American Thoracic Society 113th International Conference, which ran May 19–24, 2017. Preliminary data from the first four patients showed a significant association between selective vasodilation (opening of the blood vessels) in the lungs and ventilation, and an average reduction in systolic pulmonary arterial pressure (sPAP) of 17.4%. Full trial results are expected in mid-2017, the company reported.

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