Bellerophon Announces Positive Results for INOpulse Therapy for Pulmonary Hypertension Associated with COPD

INOpulse as a therapy for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) showed promising results in a Phase 2 clinical trial, Bellerophon Therapeutics, the clinical-stage company developing the INOpulse program, announced.

INOpulse is a portable nitric oxide delivery system being developed for the treatment of PH-COPD. Nitric oxide is a potent vasodilator that widens blood vessels.

“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, chairman of Bellerophon’s PH-COPD steering committee, said in a press release.

INOpulse’s effects on vasodilation and on patients’ hemodynamics and exercise capacity were assessed in a four-week, Phase 2 trial (NCT02267655). The study enrolled 10 patients with PH-COPD and used a dose of 30 mcg/kg IBW/hr (iNO 30).

Results showed that the treatment led to a significant dilation of blood vessels relative to baseline. Also, nitric oxide delivery resulted in a significant correlation between ventilation and vasodilation, supporting a targeted delivery towards the lungs’ alveoli, the tiny sacs where the exchange of oxygen and carbon dioxide takes place.

Researchers also observed that INOpulse use led to significant and clinically meaningful increases in six-minute walking distance (6MWD, a measure of exercise capacity), at both two weeks and four weeks, relative to baseline.

A clinically significant decrease of 19.9% in systolic pulmonary arterial pressure (sPAP) at four weeks was also observed.

“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.

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

Furthermore, the therapy was found to be safe, without any reports of safety concerns.

“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,” Tenenbaum added.

Bellerophon is conducting additional clinical trials to investigate INOpulse as a therapy for pulmonary arterial hypertension (NCT02725372), and recently concluded a Phase 2 clinical trial in idiopathic pulmonary fibrosis patients with pulmonary hypertension.