Bellerophon announces fda acceptance of change to ongoing phase 3 rebuild study of inopulse® for treatment of fibrotic interstitial lung disease

Warren, n.j., sept. 27, 2022 (globe newswire) -- bellerophon therapeutics, inc. (nasdaq: blph) (“bellerophon” or the “company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, announced today that the u.s. food and drug administration (fda) has accepted the company's 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 and maintains 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.
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