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Bellerophon completes patient enrollment for Phase 2 Trial of INOpulse

Bellerophon Therapeutics has completed enrollment for its Phase 2 clinical trial of INOpulse indicated to treat pulmonary arterial hypertension (PAH) patients.

Designed to deliver brief, controlled pulses of nitric oxide, a selective, short-acting pulmonary vasodilator that are inhaled by the patient, the portable device INOpulse enables the treatment of ambulatory patients on daily basis outside the hospital.

The 80-patient Phase 2 clinical trial is a randomized, placebo-controlled trial of INOpulse as an add-on therapy for use in patients whose disease is progressing in spite of treatment with other PAH medications.

Being conducted at 52 sites in the US and Canada, the Phase 2 trial will evaluate the safety, tolerability and efficacy in this population of two different doses of INOpulse for PAH and is scheduled to be completed by the end of 2014.

The primary endpoint of the trial includes a change in pulmonary vascular resistance at 16 weeks from baseline while secondary endpoints involve change in mean pulmonary arterial pressure and cardiac index as well as change in six-minute walk distance.

Bellerophon interim chief executive officer Daniel Tasse said the U.S. Food and Drug Administration has granted orphan drug designation for nitric oxide for the treatment of PAH, which will give the company seven years of exclusivity in the U.S. if INOpulse is the first inhaled nitric oxide therapy approved in this indication.

"There is presently no cure for PAH and, despite several approved therapies, the mortality rate remains high. The completion of enrollment in this important Phase 2 trial is therefore a key milestone for Bellerophon, and we look forward to the continued development of this potential new first-in-class therapy," Tasse added.

PAH is a life-threatening and progressive disorder, which is characterized by abnormal constriction of the arteries of the lung, leading to increased blood pressure in the lungs and abnormal strain on the heart’s right ventricle, finally leading to heart failure.