Bellerophon gets approval in Belgium to begin Phase II trial of INOpulse to treat PH-COPD

25 July 2016 (Last Updated July 25th, 2016 18:30)

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).

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 INOpulse delivery system delivers nitric oxide in a targeted way towards the well-functioning part of the lung."

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.