US-based biotechnology firm Bellerophon Therapeutics has reported that its Phase III REBUILD clinical trial of INOpulse for the treatment of fibrotic interstitial lung disease (fILD) failed to meet its primary endpoint.
The placebo-controlled, randomised, double-blind study assessed the safety and efficacy of INOpulse in patients with fILD.
A total of 145 patients with fILD were randomised to receive INOpulse at a dose of iNO45 or a placebo.
The change in moderate to vigorous physical activity (MVPA), as measured by actigraphy after 16 weeks of chronic treatment, was the study’s primary endpoint.
In the trial, iNO45 performed worse than the placebo by 5.49 minutes a day.
The trial’s secondary endpoints showed minimal difference between the two groups, with none approaching statistical significance.
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Overall activity and six-minute walking distance, as assessed over 16 weeks of blinded treatment, showed benefits in favour of iNO45.
Patient-reported outcomes were found to be slightly in favour of the placebo, while time-to-event assessments demonstrated little difference and none were statistically significant.
INOpulse was safe, well-tolerated and consistent with the overall safety profile demonstrated in Phase II and other INOpulse programmes in PH-Sarcoidosis and PH-COPD.
Bellerophon Therapeutics CEO Peter Fernandes said: “The REBUILD study did not match the outcomes we saw in the exploratory Phase II 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.”
Based in New Jersey, Bellerophon Therapeutics develops therapies to address significant unmet medical needs in the treatment of cardiopulmonary diseases.