Bellerophon‘s positive top-line results from its Phase 2 trial testing INOpulse as a potential therapy for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) will be presented at an upcoming conference, the company announced.
Results of the trial, which were initially announced in September 2017, showed that INOpulse, a portable device that delivers a vasodilator gas called nitric oxide, or iNO, improved blood flow and increased patients’ exercise capacity. Patients can use the device daily, either at home or elsewhere.
Findings will be shared in a poster titled “Pulsed Inhaled Nitric Oxide (NO) Improves Exercise Tolerance in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients with Pulmonary Hypertension (PH)” at the American Thoracic Society 114th International Conference on May 21 in San Diego. The conference runs from May 18-23.
In the Phase 2 trial (NCT02267655), 10 PH-COPD patients underwent treatment with INOpulse for four weeks. The aim was to assess the therapy’s effects on patients’ blood flow — a parameter called hemodynamics — and exercise capacity.
Results showed that all patients experienced a significant increase in blood vessel volume — an average of 4.2% — following INOpulse treatment. Researchers found that this increase in vasodilation was associated with better ventilation.
Additionally, patients who completed four weeks of iNO therapy experienced significant reductions in their pulmonary arterial pressure — the pressure on the arteries that supply blood to the lungs — and better exercise capacity. This was shown by an average increase of 50.4 meters in the six-minute walk test, a measure of exercise capacity that records the distance walked in six minutes.
The treatment was found to be well-tolerated with no related safety concerns.
“We are pleased to present the positive results of our Phase 2 study at ATS, which demonstrate the potential for pulsed iNO therapy to improve pulmonary hemodynamics and exercise capacity in PH-COPD patients. Based on INOpulse’s ability to provide targeted vasodilation, as well as improve ventilation-perfusion matching, we believe it could fill the treatment void as the first approved therapy in PH-COPD,” Fabian Tenenbaum, CEO of Bellerophon Therapeutics, said in a press release.
“The co-morbidity of pulmonary hypertension in COPD greatly reduces patient quality of life and expected survival. There are currently no approved treatments for this serious condition, resulting in a large and profound unmet clinical need,” Tenenbaum said. “We look forward to continuing to progress INOpulse in this serious medical condition and recently reached agreement with the FDA on the design of our next Phase 2b study in our PH-COPD development program.”
This Phase 2b study will be conducted in the U.S. and is expected to enroll about 90 PH-COPD patients.