Study Met its Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements in Six-Minute Walking Distance, Hemodynamics and Blood Vessel Volume
WARREN, NJ, USA I September 05, 2017 I Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced positive top line data from a Phase 2 clinical trial evaluating INOpulse® in patients with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD).
The Phase 2 study was designed to assess the acute effect of pulsed inhaled nitric oxide (iNO) on targeted vasodilation and the chronic effect (4 weeks) of iNO on hemodynamics and exercise capacity. The study enrolled 10 subjects and used a dose of 30 mcg/kg IBW/hr (iNO 30). The acute results showed a statistically significant increase (average 4.2%) in blood vessel volume on iNO compared to baseline (p=0.03), and a statistically significant correlation in Ventilation-Vasodilation (p=0.01), indicating targeted delivery to the well-ventilated alveoli. The chronic results demonstrated statistically significant and clinically meaningful increases in six-minute walking distance (6MWD) at both 2 weeks and 4 weeks (+50.7m; p=0.04), as compared to baseline. In addition, the study demonstrated a statistically significant and clinically meaningful decrease of 19.9% in systolic pulmonary arterial pressure (sPAP) at 4 weeks (p=0.02), as compared to baseline. The therapy was well tolerated with no related safety concerns.
“COPD patients with associated pulmonary hypertension have a poor prognosis with an approximately 4-year life expectancy and high hospitalization rates, which represents a significant unmet medical need for a safe and effective long-term treatment,” said Dr. Raymond L. Benza of the Cardiovascular Institute at Allegheny General Hospital, Pittsburgh, PA and Chairman of Bellerophon’s PH-COPD steering committee. “Collectively, these Phase 2 data demonstrate the promising potential of INOpulse to safely deliver pulsatile nitric oxide in a targeted manner to achieve medically and statistically significant improvements in exercise capacity and hemodynamics.”
“These compelling data confirm and build upon the results from our previous acute studies, and reaffirm INOpulse’s potential role as a first-in-class therapy for PH-COPD patients,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “We believe INOpulse’s ability to provide targeted vasodilation to the well-ventilated areas of the lung could allow it, if approved, to become a safe and effective treatment for over 700,000 PH-COPD patients in the U.S. for whom there are currently no marketed therapies. We now have an experienced steering committee in place chaired by Dr. Benza to help guide our next clinical studies and the regulatory pathway towards the potential approval of INOpulse in PH-COPD.”
In addition to PH-COPD, Bellerophon is currently conducting a Phase 3 trial for INOpulse for the treatment of pulmonary arterial hypertension (PAH), with interim and top-line data expected in 2018, and recently completed a Phase 2 clinical trial that investigated INOpulse in idiopathic pulmonary fibrosis patients with pulmonary hypertension (PH-IPF). The results of the PH-IPF trial were recently presented at the American Thoracic Society meeting and the next step in this program will be to conduct a larger Phase 2b study to inform the design of a pivotal registration trial.
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 system. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials. 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 Interstitial Lung Disease (PH-ILD), both of which are in Phase 2 development. For more information, please visit www.bellerophon.com.
SOURCE: Bellerophon
