The INOpulse nitric oxide delivery system met its primary Phase 2 clinical trial goal of increasing the blood-vessel volume of pulmonary hypertension patients with idiopathic pulmonary fibrosis (PH-IPF), according to its maker, Bellerophon Therapeutics.
Researchers presented the results at the American Thoracic Society International Conference in Washington on May 22. The presentation was titled “Unravelling the Mode of Action of Pulsed Inhaled Nitric Oxide in Severe IPF Using Functional Respiratory Imaging (FRI).”
The company also presented preliminary results of a study of INOpulse’s ability to widen the blood vessels of pulmonary hypertension patients with chronic obstructive pulmonary disease (PH-COPD). That study was titled “Pulsed Inhaled Nitric Oxide Has the Potential to Improve Exercise Tolerance in Severe COPD Subjects with Pulmonary Hypertension.”
Not only did four weeks of INOpulse therapy widen blood vessels, but it also reduced pulmonary artery pressure, or blood pressure in the heart’s pulmonary artery, an average of 17.4%. The full study results are expected shortly.
The bottom line was that INOpulse improved both hypertension and the conditions associated with them — either IPF or COPD.
INOpulse delivers inhaled nitric oxide to patients’ respiratory systems in pulses. Bellerophon describes the device as an extension of the continuous-flow inhaled nitric oxide system that hospitals use.
Nitric oxide is a vasodilator, or therapy that widens blood vessels. It can reduce hypertension in patients with IPF, studies have shown.
Bellerophon conducted the Phase 2 trial (NCT01457781) to evaluate INOpulse’s ability to widen PH-IPF patients’ blood vessels and improve their blood-flow dynamics and exercise capacity.
The device increased patients’ blood-vessel volume by 15.3%, meeting the trial’s primary objective. The nitric oxide the device delivered also improved ventilation — or the lungs’ ability to inhale and exhale. That improvement was the result of wider blood vessels, researchers said.
In addition, INOpulse reduced systolic pulmonary artery pressure by 14 percent, and improved patients’ exercise capacity.
Bellerophon now plans a Phase 2b clinical trial with a larger patient population.“Pulsed iNO has a potentially unique and distinguishing advantage,” Dr. Wilfried De Backer, director of the Department of Pulmonary Medicine at University Hospital and University of Antwerp, said in a press release. “The data from these trials shows that it can provide selective vasodilation to the well-functioning parts of the lung, allowing for improvement in hemodynamic [blood-flow] measures as well as increased exercise capacity without worsening oxygenation.”
There are no treatments yet for PH combined with either IPF or COPD. That has led to high numbers of hospitalizations and a high mortality rate among these patients.
Therapies are available for people with PH who have other diseases, but they have been ineffective in PH patients with IPF or COPD.
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