Bellerophon Therapeutics will soon initiate a Phase 3 trial for its INOpulse inhaled nitric oxide therapy for the treatment of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).
The company completed its End-of-Phase 2 Meetings with the US FDA and has finalized the key elements of its planned pivotal Phase 3 study. Those elements include:
- The use of moderate to vigorous physical activity (MVPA) as the primary endpoint for approval,
- the patient population of pulmonary fibrosis subjects at risk of PH,
- the dose of iNO45 (45 mcg/kg IBW/hr).
According to Bellerophon, these elements were evaluated in its Phase 2 clinical trial and the therapy achieved a statistically significant improvement (p=0.02) in moderate to vigorous physical activity versus placebo.
“We are very pleased with the alignment reached with the FDA on the design of our pivotal Phase 3 trial which allows us to move confidently towards the initiation of this important study,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “There is a pressing need to develop a safe and effective treatment for patients with PH-PF, a disease with no approved therapies and a median life expectancy of approximately 18 months.
“INOpulse, with its targeted pulmonary vasodilation, would potentially become the first therapy to treat a broad PH-PF population that includes patients at low, intermediate and high risk of pulmonary hypertension. We look forward to initiating our pivotal Phase 3 study in PH-PF shortly.”
