Bellerophon Therapeutics recently announced that the Phase 3 INOvation-1 clinical trial evaluating the safety and efficacy of the INOpulse delivery of nitric oxide (NO) in patients with pulmonary arterial hypertension (PAH) has enrolled its first patient. In addition, the company is developing two other INOpulse devices, which may be used to treat patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), and pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF).
INOpulse is a proprietary device consisting of a pulsative delivery system of nitric oxide (NO), a molecule that is naturally produced by the endothelial cells lining the blood vessels to promote the opening of the arteries, or vasodilation. Patients with PAH are characterized by high blood pressure in the arteries that take blood from the heart to the lungs, and it is expected that inhaled NO will be absorbed by the smooth muscle cells that surround the blood vessels, inducing their relaxation and reducing blood pressure in the lungs.
INOvation-1 is expected to enroll 188 PAH patients in 17 different countries, and is one of two planned studies that will involve a total of about 450 people. The primary endpoint for each is the Six Minute Walk Distance, with Time to Clinical Worsening (TTCW) as a secondary endpoint, pooled across both trials.
Bellerophon released results from the Phase 2 long-term extension trial that preceded this Phase 3 study in February, demonstrating a sustained clinical benefit in PAH patients on long-term oxygen therapy, whose disease was progressing despite use of one or more treatments.
Given that NO is rapidly inactivated after coming into contact with blood, the gas delivered by INOpulse through inhalation is expected to act locally in the lungs with minimal effects in other parts of the body, which is important in reducing potential side effects.
“The initiation of enrollment in INOvation-1, Bellerophon’s first Phase 3 trial in PAH, marks an important milestone for the company and offers a new potential treatment to patients who continue to suffer poor outcomes,” Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, said in a press release. “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.”
The use of INOpulse devices in patients with PH-IPF and PH-COPD is currently being evaluated in Phase 2 clinical trials, and results are expected by the end of 2016.