Bellerophon Therapeutics has received health authority approval in Belgium to commence a Phase 2 trial for INOpulse, its patented and proprietary pulsatile nitric oxide (NO) delivery device, to treat pulmonary hypertension in chronic obstructive pulmonary disease, or PH-COPD.
This follows results from the company’s Phase 2a study and proof of mechanism work, which indicated that INOpulse could be both safe and effective in PH-COPD.
Bellerophon expects to enroll the first patient in the third quarter of 2016 with results of the trial expected before year end, according to a company news announcement.
Approximately 12 million people in the United States suffer from COPD of which approximately 700,000 are PH-COPD patients. Severe COPD is often associated with secondary pulmonary hypertension, which worsens its prognosis, is associated with high hospitalization rates, impaired exercise capacity and carries with it a median life expectancy of four years. Earlier Phase 2a data showed that in an acute setting, Bellerophon’s INOpulse safely reduced PH for COPD patients and increased blood volume in the vessels within the lung.
The Phase 2 study of INOpulse for PH-COPD is designed to demonstrate the potential benefit of INOpulse on exercise capacity for patients suffering from PH-COPD and will enroll 10 COPD patients with PH on LTOT.
The trial is an open-label study of iNO 30 mcg/kg IBW (Ideal Body Weight)/hour for four weeks with a follow up visit two weeks after discontinuation of iNO. After four weeks of treatment, patients’ vasodilation in pulmonary arteries will be measured by high resolution CT scanning (HRCT), with a key secondary endpoint of 6MWD at four weeks.
“This study builds on the results of earlier work by the Vonbank group in Austria, our own Phase 2a 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,” stated Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics.
“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 and reporting results by year end 2016,” concluded Peacock.