Bellerophon Therapeutics Inc announced positive interim data from part 2 of a phase II study on INOpulse for the treatment of pulmonary arterial hypertension (PAH). Results from the study supported data from part 1 of the phase II study on INOpulse and also indicated a sustainability of benefit in PAH patients.
The company also announced that the FDA has issued a Special Protocol Assessment for the phase III program on INOpulse, which is expected to be initiated later this year. The phase III program will include two studies — one with two treatment arms (iNO 75 and placebo) and the other with three treatment arms (iNO 75, iNO 50 and placebo) — undertaken either sequentially or simultaneously.
We note that INOpulse is also being evaluated for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is currently in phase II development.
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