Bellerophon Therapeutics (NASDAQ: BLPH) this morning said the U.S. FDA has approved proposed modifications to the company’s phase 3 program for INOpulse in Pulmonary Arterial Hypertension (PAH). The protocol changes have the potential to reduce the time to market and are expected to result in “substantial” costs savings. “We are gratified that the FDA has agreed with the proposed modifications to our PAH Phase 3 program, which have the potential to make INOpulse available to PAH patients approximately two years earlier than otherwise would have been possible under the original Phase 3 program,” Bellerophon president and CEO Fabian Tenenbaum stated in the news release. “PAH is a rare disease and many patients continue to suffer from poor outcomes with currently available treatments. We believe INOpulse has the potential, if approved, to be an effective and well-tolerated treatment alternative for these patients. The modification of our Phase 3 program will also substantially reduce Bellerophon’s clinical development costs.”
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About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first candidate is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF); both of these products are in Phase 2 development. For more information, please visit www.bellerophon.com
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