- The FDA has accepted Bellerophon Therapeutics Inc’s (NASDAQ:BLPH) proposal to reduce the study size for its ongoing registrational REBUILD Phase 3 trial of INOpulse for the treatment of fibrotic Interstitial Lung Disease (fILD).
- The new study size of 140 subjects does not impact the trial’s principal objective or endpoints. It maintains a power of >90% (p-value < 0.01) for the primary endpoint of Moderate to Vigorous Physical Activity (MVPA) based on the effect size observed in Phase 2.
- Following the evaluation of baseline MVPA characteristics and review of safety data of the randomized subjects in the ongoing Phase 3 REBUILD study, the trial’s independent Data Monitoring Committee (DMC) supported reducing the target study size from 300 to 140 subjects.
- “With over 100 subjects randomized to date, we expect to complete enrollment in the first quarter of 2023 and anticipate the availability of pivotal top-line data in the third quarter of 2023,” said Naseem Amin, Chairman of Bellerophon.
- Price Action: BLPH shares are up 28.39% at $1.24 on the last check Tuesday.
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