Bellerophon Therapeutics, who recently completed enrollment for a Phase 2 clinical trial evaluating INOpulse in patients with pulmonary hypertension, has fully enrolled another Phase 2 clinical trial, this time evaluating INOpulse in 159 pulmonary hypertension patients with chronic obstructive pulmonary disease (COPD).
The clinical trial is a two-part, dose-confirming study. The first part will identify a dose of inhaled nitric oxide within the range of 0.003 – 0.015 mg/kg ideal body weight (IBW) with outcomes measures of a change in pulmonary arterial systolic pressure and a decrease of more than 5 mmHg partial pressure of oxygen in arterial blood relative to baseline. Patients who partake in the first part (80 will be randomized among four groups) will be permitted to partake in the second part (60 will be randomized among three groups). The second part will use the same outcome measures, but the doses will be 0.030 or 0.075 mg/kg IBW. Both parts are placebo controlled.
Patients are between the ages of 40 and 80 years and have a confirmed diagnosis of World Health Organization Group 3 pulmonary hypertension in relation to a diagnosis of COPD. All were receiving long term oxygen therapy for more than three months before enrolling in the study.
Pulmonary hypertension is an occasional, serious complication related to COPD. The relationship is heterogeneous among patients, but it is commonly believed pulmonary hypertension results from vasoconstriction driven by hypoxic (low oxygen) conditions in COPD. Currently, the preferred treatment option is oxygen therapy, but it can be burdensome to patients.
Bellerophon’s INOpulse medication is inhaled nitric oxide delivered by the INOpulse device. Nitric oxide is a vasodilator that works by relaxing smooth muscles around blood vessels. The relaxation allows increased blood flow and lessens the pressure load the heart must work against to deliver blood to the rest of the body. As INOpulse is portable, it will enable patients to receive treatments daily outside the hospital while still being able to move around and perform normal activities.