US-based biotherapeutics company Bellerophon has secured the Belgium health authority’s approval to initiate the Phase II trial for INOpulse to treat pulmonary hypertension in chronic obstructive pulmonary disease (PH-COPD).
INOpulse is Bellerophon’s patented pulsatile nitric oxide (NO) delivery device which is being developed to treat pulmonary arterial hypertension (PAH), PH-COPD, and pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF).
The approval follows the company’s Phase IIa trial which suggested that INOpulse is both safe and effective to be used to treat PH-COPD.
The Phase II trial of INOpulse intended to exhibit the benefit of INOpulse on exercise capacity for patients suffering from the disease.
Bellerophon Therapeutics chairman and CEO Jonathan Peacock said: “This study builds on the results of earlier work by the Vonbank group in Austria, our own Phase IIa acute dose ranging study, as well as the results of a trial conducted in the Department of Respiratory Medicine at the University Hospital Antwerp, by Professor Wilfried De Backer and Bellerophon, published in the peer-reviewed International Journal of COPD (Hajian et al., Pulmonary vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension, International Journal of COPD, 2016, 11:1533-1541).”
COPD is a chronic progressive disease which is characterised by chronic inflammation and destruction of the airways and lung tissue leading to high-hospitalisation rates, impaired exercise capacity with a median life expectancy of four years.
The INOpulse delivery system delivers nitric oxide in a targeted way towards the well-functioning part of the lung.
The action stems from the theory that inhaled nitric oxide (iNO) is very short-acting and is deactivated quickly after contacting blood, INOpulse delivers it to well-ventilated parts of the lung to open up the blood vessels where good gas exchange is possible, while leaving body’s protective mechanism in other parts of the lung unaffected.
