Thinly traded nano cap Bellerophon Therapeutics (NASDAQ:BLPH) is up 11% premarket on modest volume on the heels of its announcement that it has reached agreement with the FDA on the design of a Phase 2 clinical trial evaluating INOpulse in patients with pulmonary hypertension associated with Interstitial Lung Disease (ILD).
The study, called iNO-PF, will enroll ~40 patients with pulmonary fibrosis, with half at intermediate-to-high risk of pulmonary hypertension. The FDA has agreed to eliminate the need for right heart catheterization, an invasive procedure that would increase the risk for study participants. The trial should commence in 2018.
INOpulse is a drug-device combination system that delivers pulsed doses of nitric oxide. It is portable, suitable for at-home use and automatically adjusts to the patient's breathing patterns to deliver consistent dosing.
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