|View printer-friendly version|
|Positive Clinical Data on INOpulse® Presented at the American Thoracic Society 113th International Conference|
Acute and Chronic Benefits Demonstrated with INOpulse in Patients with PH-IPF; Patients Achieved Statistically Significant Increases in Blood Vessel Volume; Consistent Improvements were Observed in Hemodynamics, 6MWD and Composite Endpoints of Oxygen Saturation and 6MWD
Preliminary Results from an Ongoing Study in PH-COPD Support a Consistent Improvement in Vasodilation and Meaningful Reduction in Pulmonary Artery Pressures with 4 Weeks of INOpulse Treatment
“Pulmonary Hypertension with IPF or COPD has no approved therapies and has been associated with increased hospitalizations and mortality. The therapies used in other pulmonary hypertension populations, which act systemically, have failed to show a benefit for these patients, creating a critical unmet need for effective and safe long-term treatment options,” said Prof. W. De Backer MD, Director in the Department of Pulmonary Medicine, University Hospital and University of
The PH-IPF study was a proof of concept study (n=4) designed to evaluate the ability of pulsed inhaled nitric oxide (iNO) to provide selective vasodilation as well as assess the potential for improvement in hemodynamics and exercise capacity in PH-IPF patients. The study met its primary endpoint showing an average of 15.3% increase in blood vessel volume (p<0.001) during acute inhalation of iNO as well as showing a significant association between ventilation and vasodilation, demonstrating the ability of INOpulse to provide selective vasodilation to the better ventilated areas of the lung. The study showed consistent benefit in hemodynamics with a clinically meaningful average reduction of 14% in systolic pulmonary arterial pressure (sPAP) with acute exposure to iNO. The study also assessed the chronic effects of iNO on exercise capacity showing an average 75 meter improvement in 6MWD and consistent improvement of approximately 80 m% in composite endpoints of 6MWD and oxygen saturation with four weeks of treatment. The study assessed both the iNO 75 and iNO 30 dose, supporting iNO 30 as a potentially safe and effective dose.
The next step in this program will be to conduct a larger Phase 2b study to inform the design of a pivotal registration trial.
The company also shared preliminary results of an ongoing PH-COPD study (n=10) designed to evaluate the acute effects of pulsed iNO on vasodilation as well as the chronic effect on hemodynamics and exercise tolerance. The interim data results from the first four patients showed a significant association between ventilation and vasodilation on acute treatment with iNO, suggesting that regions with better ventilation experience greater vasodilation. In addition, a meaningful reduction in sPAP (average 17.4%) was seen on all patients with chronic treatment of iNO. The full study results are expected around the middle of 2017.
Contacts At Bellerophon: