Bellerophon Therapeutics (NSDQ:BLPH) presented data for its INOpulse nitric oxide device in patients with pulmonary arterial hypertension at the International Society of Heart and Lung Transplantation’s annual meeting.
Researchers studied the effects of pulsed inhaled nitric oxide, delivered by the INOpulse device in 10 patients with pulmonary arterial hypertension both before and after exercise. The patients previously had a CardioMEMS device implanted as part of an ongoing study.
The study’s primary endpoint was a measurement of the difference in pulmonary artery pressures and total pulmonary resistance, before and after exercise. The researchers also measured exercise markers like a 6 minute walk test distance, oxygen saturations and other parameters from the CardioMEMS device.
Readings from the CardioMEMS device were taken a 6 time points – baseline, after a 6 minute walk test, after 30 minutes rest, 30 minutes after drug wash-in, after another 6 minute walk test and a final reading 30 minutes after drug discontinuation.
Patients who received inhaled nitric oxide consistently improved in regards to “at rest” measurements of pulmonary arterial pressure, cardiac index, RV stroke work index and effective compliance. Researchers said this trend was preserved with exercise when compared to patients who did not receive inhaled nitric oxide.
The inhaled nitric oxide did not appear to impact systemic blood pressure, heart rates or respiratory rates, according to the team.
“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,” lead investigator Dr. Raymond Benza said in prepared remarks. “PAH continues to be a life-threatening, progressive disorder, despite the availability of several approved treatments. 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.”
Bellerophon said it expects topline results in mid-2018, with interim data at the end of this year. The company added that it has an agreement with the FDA that the company’s Phase III INOvation-1 trial and a 2nd confirmatory withdrawal study can serve to support a New Drug Application filing for INOpulse in PAH.
BLPH shares fell -18% today, trading at $1.21 in mid-afternoon activity.