Bellerophon Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted the Company's proposal to reduce the study size for its ongoing registrational REBUILD Phase 3 trial of INOpulse for the treatment of fibrotic Interstitial Lung Disease. The new study size of 140 subjects does not impact the trial's principal objective or endpoints and maintains power of >90% for the primary endpoint of Moderate to Vigorous Physical Activitybased on the effect size observed in Phase 2. Following the evaluation of baseline MVPA characteristics, as measured by actigraphy, compliance to treatment and review of safety data of the randomized subjects in the ongoing Phase 3 REBUILD study, the trial's independent Data Monitoring Committee supported reducing the target study size from 300 to 140 subjects. The REBUILD study is a Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide in subjects on long-term oxygen therapy who are at risk for pulmonary hypertension associated with pulmonary fibrosis.

The study plans to enroll 140 fILD subjects who will be treated with either INOpulse at a dose of iNO45 or placebo. The trial's primary endpoint is the placebo corrected change in MVPA, as measured by actigraphy.