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.”