Bellerophon Therapeutics (BLPH) Enrolls First Patient in Phase 3 INOvation-1
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Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) announced that the first subject has been enrolled in the Phase 3 INOvation-1 clinical trial. The first patient was enrolled by Jeremy Feldman, MD, Principal Investigator at Arizona Pulmonary Associates, Ltd.
INOvation-1 is a clinical trial evaluating the efficacy and safety of the INOpulse® delivery system for the treatment of patients with Pulmonary Arterial Hypertension (PAH) with an anticipated enrollment of 188 subjects in 17 countries. The INOpulse delivery system utilizes a proprietary technology to deliver pulsatile inhaled nitric oxide allowing for use in a portable chronic setting.
Bellerophon has also enrolled the first subject in a Phase 2 trial evaluating the safety and efficacy of the INOpulse delivery system in patients with pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF) in collaboration with Professor W. DeBacker, MD, Director Department of Pulmonary Medicine, University Hospital and University of Antwerp.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “The initiation of enrollment in INOvation-1, Bellerophon’s first Phase 3 trial in PAH, marks an important milestone for the company and offers a new potential treatment to patients who continue to suffer poor outcomes. Additionally, with the initiation of the clinical trial in IPF and a planned clinical trial in pulmonary hypertension associated with COPD, we are positioned to gain additional insight in 2016 for our future development programs for INOpulse.”
INOpulse Clinical Program Focus
The focus of the company’s INOpulse clinical program is the continued development of its nitric oxide therapy for patients with pulmonary hypertension (PH). The lead indication for INOpulse is Pulmonary Arterial Hypertension (PAH), for which FDA issued Special Protocol Assessment for the Phase 3 program and agreement was reached with European Medicines Agency (EMA) through its Scientific Advice Working Party (SAWP) process. The Phase 3 program will include 2 confirmatory trials in approximately 450 patients. The primary endpoint for each trial is Six Minute Walk Distance (6MWD), with Time to Clinical Worsening (TTCW) as a secondary endpoint, pooled across both trials. In February 2016, Bellerophon released encouraging results from the long-term extension of the company’s Phase 2 PAH clinical trial demonstrating benefit for patients on long-term oxygen therapy whose disease is progressing despite taking one or more existing PAH therapies. Bellerophon also plans to continue with Phase 2 testing in PH associated with Chronic Obstructive Pulmonary Disease (PH-COPD) and PH associated with Idiopathic Pulmonary Fibrosis (PH-IPF) for which results are anticipated by the end of 2016.
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