Bellerophon Therapeutics, Inc. announced that the last patient has been enrolled in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD). The Company now expects to report pivotal top-line results in mid- 2023. The REBUILD study is a pivotal Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide (iNO) in patients at risk for pulmonary hypertension associated with pulmonary fibrosis on long-term oxygen therapy.

With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy, based on the results from Phase 2, and will be the basis for the submission of NDA for approval in fILD.