The first patient has been enrolled in Bellerophon Therapeutics Inc’s REBUILD Phase 3 registrational clinical study evaluating INOpulse, a pulsed inhaled nitric oxide therapy, as a potential treatment for fibrotic interstitial lung disease (fILD).
REBUILD is a Phase 3 randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of pulsed iNO [at a dose of 45 mcg/kg ideal body weight (IBW)/hour] versus placebo in fILD patients at risk of pulmonary hypertension (PH) on long-term oxygen therapy. The REBUILD trial is planned to enroll 300 patients who will receive either INOpulse or placebo for a 16-week blinded treatment period, after which patients are eligible to rollover into an open-label extension. The primary endpoint is change in moderate to vigorous physical activity (MVPA), as previously agreed upon with the US FDA.
Bellerophon previously reported positive top-line results from its iNO-PF Phase 2 study, a randomized, double-blind, placebo-controlled clinical study of INOpulse for the treatment of fILD. The Phase 2 studies established iNO45 as the preferred dose for the REBUILD Phase 3 study, with patients who received iNO45 over 16 weeks demonstrating clinically meaningful and statistically significant improvement in MVPA of 20% over baseline compared to placebo (p=0.02). Improvements in MVPA were further supported by placebo-corrected benefits in other key parameters, as measured by two patient-reported questionnaires, the University of California, San Diego Shortness of Breath Questionnaire, and the St. George’s Respiratory Questionnaire. The safety and tolerability profile of INOpulse in the double-blind period of iNO-PF has been maintained in the ongoing open-label extension period.
“Nitric Oxide is a pulmonary vasodilator that improves ventilation-perfusion matching, which can be impaired by systemic vasodilators. The benefits we observed in the Phase 2 study and into open-label extension, including activity levels and patient reported outcomes, underscore INOpulse’s potential to address this significant unmet medical need. I am excited to advance the Phase 3 study with the enrollment of the first patient, and look forward to the continued development of the promising INOpulse therapy for fILD,” said Jeremy Feldman, MD, Director Pulmonary Hypertension Program, Arizona Pulmonary Specialists and a lead investigator for the Phase 3 study.