The last patient has completed blinded treatment in Bellerophon Therapeutics’ (NASDAQ:BLPH) Phase 3 REBUILD study of INOpulse, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease.
The company expects to report top-line results from the study in mid-2023.
The REBUILD study enrolled 145 patients with fibrotic interstitial lung disease 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 as measured by actigraphy after 16 weeks of chronic treatment.
If approved, INOpulse would become the first therapy to treat a broad fibrotic interstitial lung disease population, including patients at low-, intermediate- and high-risk pulmonary hypertension.