It presented the results at the 37th Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT) in San Diego April 5-8. The title of the presentation was “Effects of Ambulatory Inhaled Nitric Oxide on Exercise Induced Increases in Pulmonary Pressures.”
“This study reinforces existing knowledge and provides real-world information that suggests pulsed inhaled nitric oxide, as delivered by the iNO pulse device, may have a role in blunting pulmonary pressures, both with and without exercise in PAH patients,” Dr. Raymond L. Benza, lead investigator of the clinical trial, said in a press release.
The goal of the study (NCT02734953) was to see whether iNO could help patients on two fronts. One was easing pulmonary vascular resistance, or the resistance that must be overcome to push blood through the circulatory system. The other was improving cardiac output, or amount of blood the heart pumps through the circulatory system in a minute.
The team evaluated pulmonary artery pressure (PAP), pulmonary resistance, and exercise capacity in 10 patients who used an INOpulse before and after exercising.
Before the test, researchers implanted a pulmonary artery monitoring device called a CardioMEMS in each patient. It records several vascular resistance-related parameters.
PAP, cardiac index, and right ventricular stroke work index values increased when patients exercised, researchers discovered. INO improved the values before and after exercise. In addition, iNO treatment did not cause any adverse side effects. Patients exhibited stable respiratory and heart rates throughout the study.
“PAH continues to be a life-threatening, progressive disorder, despite the availability of several approved treatments,” Benza said. “The use of the INOpulse therapy may allow for increases in exercise capacity and may have a role in the long-term treatment of these patients.”
The company is recruiting patients for its Phase 3 INOvation-1 trial (NCT02725372) to determine the effectiveness, safety, and tolerability of INOpulse in PAH patients. Initial results are expected by the end of the year.
Based on the Phase 3 trial results, and a secondary study’s results being confirmed, Bellrophon expects to file a New Drug Application with the U.S. Food and Drug Administration for using INOpulse to treat PAH patients.