Bellerophon Therapeutics recently enrolled the first participants in the Phase 3 INOvation-1 clinical trial intended to test the efficiency and safety of INOpulse for the treatment of pulmonary arterial hypertension (PAH). Patients were enrolled by Dr. Jeremy Feldman, principal investigator at Arizona Pulmonary Associates.
In PAH patients, arteries that transport blood from the heart to the lungs become gradually narrowed, which restricts blood flow and generates high blood pressure in the vessels. Several classes of PAH medications with variable outcomes are currently available. All aim to reduce symptoms and extend the life expectancy of patients.
A novel product candidate from the INOpulse program with a proprietary pulsatile nitric oxide delivery device is being developed by Bellerophon, and has passed through several testing phases.
The results from a Phase 2 PAH trial were overall positive, demonstrating the benefit of INOpulse for patients treated with long-term oxygen therapy unresponsive to existing PAH therapies. Next, the trial moved to a Phase 3 study in which the primary endpoints are changes in categories that include six minute walk distance (6MWD) and time to clinical worsening (TTCW).
INOpulse is also being tested on patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), and PH associated with idiopathic pulmonary fibrosis (PH-IPF). Those studies are currently in Phase 2; outcomes will likely be known by the end of 2016.
INOvation-1 is a clinical trial aimed to test the efficacy and safety of INOpulse delivery system in patients with PAH. The trial is expected to include 188 participants in 17 countries.
Meanwhile, the first participants in the Phase 2 trial intended to test the safety and efficacy of the INOpulse delivery system in PH-IPF patients were enrolled. That trial will be performed in collaboration with Professor W. DeBacker, MD, Director Department of Pulmonary Medicine, University Hospital and the University of Antwerp.
In a press release, Jonathan Peacock, chairman and CEO of Bellerophon Therapeutics, said enrollment in INOvation-1, Bellerophon’s first Phase 3 trial in PAH, is a milestone for the company and offers new potential treatment to patients who continue to suffer poor outcomes.
“Additionally, with the initiation of the clinical trial in IPF and a planned clinical trial in pulmonary hypertension associated with COPD, we are positioned to gain additional insight in 2016 for our future development programs for INOpulse,” Peacock said.l
Bellerophon Therapeutics is a clinical-stage biotherapeutics company specialized in the development of innovative drugs/devices for the treatment of cardiopulmonary diseases.