Bellerophon Therapeutics has enrolled the first patient in a Phase 2b clinical trial evaluating INOpulse as a treatment for pulmonary hypertension associated with interstitial lung disease, or PH-ILD.
The trial (NCT03267108) will assess the safety and effectiveness of Bellerophon’s pulsed, inhaled nitric oxide treatment for people with PH-ILD, including those with idiopathic pulmonary fibrosis, or IPF. Nitric oxide is a vasodilator, or substance that widens blood vessels.
“The initiation of our iNO-PF study represents an important milestone in our INOpulse development program,” Fabian Tenenbaum, chief executive officer of Bellerophon, said in a press release. “PH associated with ILD, including PH-IPF, are devastating conditions with no approved therapies. Patients suffering from these conditions represent an orphan [rare disease] population with a mean survival of only two years from diagnosis and for whom systemic vasodilators have proven to be ineffective.”
Researchers will gather information on patients during the first week of the study. The next eight weeks will involve treatment.
The trial’s main objective is to see whether INOpulse can increase a measure of patients’ exercise capacity known as the six-minute walk distance. Another objective will be to see if the treatment can improve the functioning of the right side of patients’ heart.
Researchers are recruiting up to 40 participants in several locations, including the Lung Research Center in Chesterfield, Missouri, where the first patient was enrolled.
Bellerophon is developing INOpulse for people with pulmonary hypertension, COPD and PH-ILD.
The company updated patients and others interested in the therapy in November 2017. Part of the update was that promising trial results had led to it working with the U.S. Food and Drug Administration to try to accelerate regulatory approval.
“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,” Tenenbaum said. “We look forward to working with our [trial] Steering Committee and investigators to continue the development of INOpulse for PH-ILD.”
Initial results of the study are expected to be available by the end of 2018. For more information on trial recruitment, please visit this link.