Bellerophon highlights Phase II data for INOpulse system
The proof-of-concept study enrolled 4 patients and was designed to evaluate the ability of pulsed inhaled nitric oxide to provide selective vasodilation. The study was also designed to assess the potential for improvement in hemodynamics and exercise capacity in the patient group.
The trial met its primary endpoint, showing an average of 15.3% increase in blood vessel volume during acute inhalation of inhaled nitric oxide. The data also showed a significant association between ventilation and vasodilation.
The researchers found consistent benefit in hemodynamics, with an average reduction of 14% in systolic pulmonary arterial pressure with acute exposure to inhaled nitric oxide.
The program’s next steps will include conducting a larger, Phase IIb study to inform the design of a pivotal registration trial, the company reported.
“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,” Dr. W. De Backer said in prepared remarks. “Pulsed iNO has a potentially unique and distinguishing advantage as 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 measures as well as increased exercise capacity without worsening oxygenation.”
Bellerophon also touted preliminary data from an ongoing study in PH-COPD, which showed consistent improvement in vasodilation and meaningful reduction in pulmonary artery pressures after 4 weeks of treatment with the INOpulse system. The trial’s full results are slated to be published in the middle of this year, according to the company.
NEXT: Pulmonx touts data for Zephyr endobronchial valves in emphysema patients