Bellerophon’s INOpulse Shows Promise in Phase 2 Clinical Trial for PH-COPD

Bellerophon recently announced promising results in a trial assessing INOpulse, its investigational treatment device for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Results showed the device led to an average increase in exercise capacity by the end of the four-week trial and a decrease in lung artery blood pressure.

INOpulse is a portable device that delivers inhaled nitric oxide (iNO) — a vasodilator that widens blood vessels — to the lungs. Patients can use the device daily, either at home or elsewhere.

PH involves high blood pressure in the arteries that supply blood to the lungs. It can occur as a result of COPD, where lungs are obstructed or blocked, making it hard to breathe. Currently, no therapies are available to treat PH-COPD.

“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,” Raymond L. Benza, of the Cardiovascular Institute at Allegheny General Hospital in Pittsburgh, and chairman of Bellerophon’s PH-COPD steering committee, said in a press release.

Bellerophon’s study (NCT02267655) assessed the effects of a four-week treatment with INOpulse on blood flow and exercise capacity in 10 patients with PH-COPD.

Results indicated that the nitric oxide delivered by the INOpulse reached the alveoli, which are tiny air sacs in the lungs. The six-minute walking distance (6MWD) test, a measure of exercise capacity where the distance walked in six minutes is recorded, increased by an average of 50.7 meters, about 166 feet.

The results showed a significant increase of 4.2% on average in blood vessel volume after four weeks. And a 19.9% drop was seen in systolic pulmonary arterial pressure (sPAP) after four weeks. sPAP is the blood pressure in the arteries that supply blood to the lungs.

“Collectively, these Phase 2 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,” Benza said.

The treatment was found to be well-tolerated with no related safety concerns.

“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,” said Fabian Tenenbaum, Bellerophon’s chief executive officer.

“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,” Tenenbaum said. “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.”