Bellerophon Therapeutics has announced it will close its Phase III study of INOpulse, its treatment for fibrotic Interstitial Lung Disease (fILD), after the trail failed to meet its primary endpoint.
The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III 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. iNO45 performed worse than placebo by 5.49 minutes per day.
The secondary endpoints demonstrated minimal difference between the two groups with none approaching statistical significance.
“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,” said Peter Fernandes, Bellerophon’s Chief Executive Officer.
