The randomized, double-blind, placebo-controlled phase II trial is expected to enroll approximately 72 patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD). The primary endpoint of the trial is to assess the effect of PRX-08066, a serotonin 5-HT2B antagonist, compared to placebo on systolic pulmonary artery pressure in patients with PH associated with COPD following two weeks of treatment.
The trial will also assess the safety and tolerability of PRX-08066 during the course of therapy.
Predix has already completed three phase I clinical trials of PRX-08066 in healthy volunteers, including a phase Ib trial in athletes conditioned to exercise at high altitudes whose pulmonary artery pressures were increased by breathing a gas with a reduced oxygen level. The results of the phase Ib trial indicated that PRX-08066 significantly reduced the increase in pulmonary artery blood pressure during hypoxic exercise, without affecting systemic blood pressure.
Predix, which recently announced a definitive agreement to merge with Epix Pharmaceuticals, is also exploring other potential indications targeting the 5-HT2B receptor, such as the treatment of irritable bowel syndrome and other diseases in which this receptor may play a key role.
“We hope to build on the promising results seen in our recently completed phase Ib trial,” said Dr Michael Kauffman, president and CEO of Predix Pharmaceuticals. “There are currently no approved drugs to treat PH associated with COPD, and based on our promising phase I data, we believe PRX-08066 may benefit patients suffering from this disease.”