05.06.2023 13:43:55

Bellerophon Therapeutics: Phase 3 REBUILD Trial Fails To Meet Primary Endpoint

(RTTNews) - Bellerophon Therapeutics, Inc. (BLPH) reported top-line results from Phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse for the treatment of fibrotic Interstitial Lung Disease. The trial did not meet its primary endpoint, related to the change in moderate to vigorous physical activity. The secondary endpoints showed minimal difference between the two groups with none approaching statistical significance. Overall, INOpulse was well-tolerated, consistent with what has been observed in the Phase 2 studies.

"The REBUILD study did not match the outcomes we saw in the exploratory Phase 2 study in this patient population; however, the overall outcome of this pivotal validation study is conclusive and we do not see a path forward for continuing the REBUILD trial," said Peter Fernandes, Bellerophon's CEO.

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