Bellerophon Therapeutics, Inc. announced top-line results from its pivotal Phase 3 REBUILD clinical trial evaluating the safety and efficacy of INOpulse® for the treatment of fibrotic Interstitial Lung Disease (fILD). The REBUILD clinical trial was designed as a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD. A total of 145 fILD patients were enrolled and treated with either INOpulse® at a dose of iNO45 or a placebo.

The primary endpoint was the change in moderate to vigorous physical activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. The trial did not meet its primary endpoint, with iNO45 performing worse than placebo by 5.49 minutes per day (p=0.2646). The secondary endpoints demonstrated minimal difference between the two groups with none approaching statistical significance.

Overall, INOpulse® was well-tolerated with no safety concerns, consistent with what has been observed in the prior Phase 2 studies. Key REBUILD clinical trial secondary endpoints and safety outputs assessed over 16 weeks of blinded treatment included: Overall Activity showed 3.51 count/min benefit in favor of iNO45 (p=0.8572) 6 Minute Walk Distance showed 0.19 meter benefit in favor of iNO45 (p=0.9866) Patient reported outcomes (St. George's Respiratory Questionnaire and UCSD Shortness of Breath) were slightly in favor of placebo, while time to event assessments (Clinical Worsening, Clinical Deterioration and Clinical Improvement) showed little difference and none were statistically significant Subjects with treatment emergent adverse events was slightly in favor of placebo (84.0% vs 74.3%) Subjects with serious treatment emergent adverse events was balanced (20% vs 21.4%) Deaths were balanced (4.0% vs 4.3%).