US-based Bellerophon shares top-line data from phase 3 trial of INOpulse for fILD
Bellerophon Therapeutics has announced top-line results from its phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse for the treatment of fibrotic Interstitial Lung Disease (fILD). The trial did not meet its primary endpoint related to the change in moderate to vigorous physical activity (MVPA), however INOpulse was safe and well tolerated, remaining consistent with its overall safety profile.
The randomised, double-blind, placebo-controlled phase 3 study aimed to assess the safety and efficacy of INOpulse for patients with fILD; 145 patients were enrolled and treated with either INOpulse or a placebo. The primary endpoint of change in MVPA was not met, with patients treated with INOpulse performing worse than placebo by 5.49minutesperday.Thesecondary endpoints demonstrated minimal difference between the two groups.
However, INOpulse was well tolerated and there were no safety concerns; this remains consistent with the established safety profile from prior phase 2 studies.
Peter Fernandes, Bellerphon’s chief executive officer, commented: “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. On behalf of Bellerophon, I would like to thank all the patients, clinical trial sites and investigators for participating and supporting the conduct of this pivotal study, allowing us to bring closure to the REBUILD clinical study.”
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