Bellerophon Therapeutics, Inc. announced that the last patient has completed blinded treatment 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 expects to report top-line results from this study in mid-2023. The REBUILD study is a Phase 3, randomized, double-blind, placebo-controlled 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.

A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo. The Phase 3 program builds on the results from the Company's previously reported Phase 2 studies which showed improvement in multiple cardiopulmonary parameters, including pulmonary vascular resistance after acute treatment and benefit in Moderate to Vigorous Physical Activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. 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.

If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension.