Bellerophon Gets Approval to Start Second Stage Study in PH-COPD

Bellerophon Therapeutics, Inc. BLPH revealed that it received health authority approval in Belgium to start a second stage study for INOpulse, its patented and proprietary pulsatile nitric oxide [NO] delivery device, to treat pulmonary hypertension in chronic obstructive pulmonary disease, or PH-COPD. Bellerophon said that the move came after results from its Phase 2a study, as well as, proof of mechanism work indicating that INOpulse could be both safe and effective in PH-COPD. The company expects to enroll the first patient in the third quarter of the current year and that the results of the study are expected before the current year. According to the company, about 12 million people suffer from COPD in the United States and 700,000 of them were PH-COPD patients. The company said that severe COPD is linked with secondary pulmonary hypertension is associated with high hospitalization rates, impaired exercise capacity and carried with it a median life expectancy of four years. Bellerophon indicated that its previous Phase 2a data demonstrated that in an acute setting, its INOpulse safely reduced PH for COPD patients. At the same time, it increased blood volume in the vessels within the lung. Its Chairman and CEO, Jonathan Peacock, said, "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." The stock traded 0.9 percent up on Monday following the news.