Bellerophon Therapeutics Reports 2015 Third Quarter Operational And Financial Results
HAMPTON, N.J., Nov. 12, 2015 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today reported operational and financial results for the third quarter ended September 30, 2015.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, commented, “We are on track to start enrollment this year in our Phase 3 program for patients suffering from Pulmonary Arterial Hypertension (PAH). We have finalized the protocol through a Special Protocol Assessment (SPA) with the FDA, which defines six minute walk distance compared to placebo after 16 weeks as the primary endpoint for approval of the therapy, and we have agreed to this protocol with the European Medicines Agency (EMA) through their Scientific Advice Working Party (SAWP) process. The Mark 2 INOpulse® delivery device is ready to be deployed in the program, providing much greater convenience and usability for patients compared to the device used in Phase 2. INOpulse has shown very encouraging results in Phase 2 for patients on long-term oxygen therapy whose disease is progressing despite taking one or more existing PAH therapies.
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Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, commented, “We are on track to start enrollment this year in our Phase 3 program for patients suffering from Pulmonary Arterial Hypertension (PAH). We have finalized the protocol through a Special Protocol Assessment (SPA) with the FDA, which defines six minute walk distance compared to placebo after 16 weeks as the primary endpoint for approval of the therapy, and we have agreed to this protocol with the European Medicines Agency (EMA) through their Scientific Advice Working Party (SAWP) process. The Mark 2 INOpulse® delivery device is ready to be deployed in the program, providing much greater convenience and usability for patients compared to the device used in Phase 2. INOpulse has shown very encouraging results in Phase 2 for patients on long-term oxygen therapy whose disease is progressing despite taking one or more existing PAH therapies.
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