Bellerophon Therapeutics completes phase 3 study for fibrotic interstitial lung disease drug
James Spargo | May 12, 2023 | News story | Medical Communications | Bellerophon Therapeutics, Cardiology, clinical trial, lung disease
US clinical stage biotherapeutics company Bellerophon Therapeutics has announced that the last patient has completed its phase 3 REBUILD study, for the treatment of fibrotic interstitial lung disease (FILD).
INOpulse is a proprietary pulsatile nitric oxide delivery system. Nitric oxide is naturally produced in the endothelial lining of the blood vessels and plays a significant role in vasodilation. When inhaled by patients with constricted blood vessels, such as those with FILD, it can help these muscles relax and cause the blood vessels to dilate. This can reduce blood pressure in the lungs, lessening the strain on the right ventricle.
REBUILD is a phase 3, randomised, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide (iNO) in patients at risk of pulmonary hypertension associated with pulmonary fibrosis on long-term oxygen therapy. 145 FILD patients were dosed with either INOpulse at a dose of iNO45 or placebo.
Results showed a 90% success in reaching the primary endpoint of a change in Moderate of Vigorous Physical Activity (MVPA) measured by actigraphy. This builds on results from the phase 2 trial, which showed improvement in multiple cardiopulmonary parameters, including pulmonary vascular resistance after acute treatment and benefit in MVPA.
Peter Fernandes, Bellerophon’s CEO, stated: “The successful and timely completion of the blinded treatment phase of our pivotal Phase 3 REBUILD trial represents a key milestone in our INOpulse development programme and we look forward to the availability of top-line results from this important study in the middle of this year.”
James Spargo
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