A Phase 2b clinical study evaluating INOpulse as a treatment for pulmonary hypertension (PH) associated with interstitial lung disease (PH-ILD) enrolled the first patient, Bellerophon Therapeutics has announced.
Patients with PH-ILD, including PH associated with idiopathic pulmonary fibrosis (PH-IPF), now lack approved medications.
“Patients suffering from these conditions represent an orphan population with a mean survival of only two years from diagnosis and for whom systemic vasodilators have proven to be ineffective,” Bellerophon CEO Fabian Tenenbaum said in a press release. The first patient was treated at the Lung Research Center in Chesterfield, Missouri, by Dr. Neil A. Ettinger.
The trial (NCT03267108) will test the safety and efficacy of pulsed, inhaled nitric oxide (iNO), a vasodilator, in patients with PH-ILD, including PH-IPF, on long-term oxygen therapy, and compare it to a placebo. Research indicates that INOpulse may help dilate blood vessels in the lungs.
In the trial, which will enroll 40 patients, investigators will mainly analyze the change in 6-minute walk distance (a standard exercise test in pulmonary rehabilitation) before and eight weeks after the start of treatment. They will assess several other parameters as well, including the Right Ventricular Function, a key determinant of longevity in PH patients.
The company expects to release top-line results later this year.
“The initiation of our iNO-PF study represents an important milestone in our INOpulse development program,” Tenenbaum said. “The proprietary and targeted INOpulse mechanism of action, and the positive data generated from our previously completed Phase 2a study, suggest that INOpulse has the potential to become the first approved therapy to address this critical treatment void.”
Bellerophon, based in Warren, New Jersey, previously conducted a Phase 1 study (NCT02267655) in PH-IPF patients. It found that INOpulse treatment improved patients’ systolic pulmonary arterial pressure (sPAP; the blood pressure in the main artery supplying blood to the lungs) and exercise capacity.
A Phase 2a trial (NCT01457781) in PAH patients further showed that INOpulse widens blood vessels, improves ventilation and sPAP, and ameliorates patients’ exercise capacity. Taken together, these results suggest that INOpulse may become the first approved treatment for PH-ILD.
Bellerophon is developing INOpulse for people with pulmonary arterial hypertension, PH-ILD, and PH associated with chronic obstructive pulmonary disease (COPD). For more information on INOpulse trial recruitment, please visit this link.