Bellerophon Therapeutics (NSDQ:BLPH) touted data today from a Phase II trial of pulsed, inhaled nitric oxide in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
The 10-patient trial was designed to evaluate the effects of pulsed, inhaled nitric oxide on targeted vasodilation and the chronic effect on hemodynamics and exercise capacity.
The data showed a statistically significant increase in blood vessel volume compared to baseline and a statistically significant increase in six-minute walking distance at 2 weeks and 4 weeks compared to baseline.
The study also showed a meaningful decrease in systolic pulmonary arterial pressure after 4 weeks. Bellerophon’s therapy was well tolerated, the company reported, with no related safety concerns.
“COPD patients with associated pulmonary hypertension have a poor prognosis with an approximately 4-year life expectancy and high hospitalization rates, which represents a significant unmet medical need for a safe and effective long-term treatment,” Dr. Raymond Benza, chairman of Bellerophon’s PH-COPD steering committee, said in prepared remarks. “Collectively, these Phase II data demonstrate the promising potential of INOpulse to safely deliver pulsatile nitric oxide in a targeted manner to achieve medically and statistically significant improvements in exercise capacity and hemodynamics.”
“These compelling data confirm and build upon the results from our previous acute studies, and reaffirm INOpulse’s potential role as a first-in-class therapy for PH-COPD patients,” CEO Fabian Tenenbaum added. “We believe INOpulse’s ability to provide targeted vasodilation to the well-ventilated areas of the lung could allow it, if approved, to become a safe and effective treatment for over 700,000 PH-COPD patients in the U.S. for whom there are currently no marketed therapies. We now have an experienced steering committee in place chaired by Dr. Benza to help guide our next clinical studies and the regulatory pathway towards the potential approval of INOpulse in PH-COPD.”