The company’s placebo-controlled study is slated to evaluate the safety and efficacy of pulsed, inhaled nitric oxide in patients with PH-ILD, including those with idiopathic pulmonary fibrosis, Bellerophon reported.
Forty patients will be enrolled in the trial, the company said, and the study’s primary endpoint is the change in six minute walk distance from baseline to week eight.
“The initiation of our iNO-PF study represents an important milestone in our INOpulse development program,” CEO Fabian Tenenbaum said in prepared remarks. “PH associated with ILD, including PH-IPF, are devastating conditions with no approved therapies. Patients suffering from these conditions represent an orphan population with a mean survival of only two years from diagnosis and for whom systemic vasodilators have proven to be ineffective.
The proprietary and targeted INOpulse mechanism of action, and the positive data generated from our previously completed Phase IIa study, suggest that INOpulse has the potential to become the first approved therapy to address this critical treatment void. We look forward to working with our Steering Committee and investigators to continue the development of INOpulse for PH-ILD.”
BLPH shares were up 1.5% on the news today, trading at $2.68 apiece in mid-morning activity.