Bellerophon Therapeutics has completed participants enrolment in the Phase III REBUILD study of its pulsatile nitric oxide delivery system, INOpulse, to treat fibrotic interstitial lung disease (fILD).
The double-blind, randomised, placebo-controlled, dose escalation and verification Phase III clinical trial has been designed for assessing the efficacy and safety of pulsed inhaled nitric oxide (iNO) in patients who are at risk for pulmonary hypertension that is associated with pulmonary fibrosis on long-term oxygen therapy.
A total of 145 participants have been enrolled in the trial.
The change in moderate to vigorous physical activity (MVPA) as measured by an actigraphy is the study’s primary endpoint.
Nitric oxide is a molecule which is naturally produced in the endothelial lining of blood vessels. It plays an important role in vasodilation, or the opening of the arteries, such as the arteries in the lung.
The company anticipates to receive the pivotal top-line results from the trial in the middle of this year.
Bellerophon Therapeutics CEO Peter Fernandes said: “This study will provide the randomised dataset to evaluate the change in moderate to vigorous physical activity (MVPA) following treatment with INOpulse in patients with fILD.
“These patients struggle to perform basic activities of daily living such as walking, climbing stairs, or showering.
“The ability to monitor changes in their level of physical activity, specifically the difference in MVPA as the novel endpoint, which correlates to household tasks and activities of daily living, has the potential to inform directly on the patient’s overall health, well-being, and quality of life.”
It intends to use the data from the REBUILD study for the submission of the new drug application (NDA) for approval of INOpulse to treat fILD.