Predix initiates Ph II trial of PRX-08066

Massachusetts, USA-based Predix Pharmaceuticals, which recently announced a definitive agreement to merge with EPIX Pharmaceuticals, says that it has initiated a Phase II clinical trial to evaluate the short-term efficacy and safety of PRX-08066, a serotonin 5-HT2B antagonist, in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.

"We hope to build on the promising results seen in our recently-completed Phase Ib trial, where adults conditioned to exercise at high altitudes that were given PRX-08066 experienced a statistically-significant reduction in systolic pulmonary blood pressure during exercise-induced hypoxia," said Michael Kauffman, chief executive of Predix, adding: "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."

The randomized, double-blind, placebo-controlled Phase II trial is expected to enroll around 72 patients with PH associated with COPD. The primary endpoint is to assess the effect of PRX-08066 compared to placebo on systolic pulmonary artery pressure in patients with this condition following two weeks of treatment. The trial will also assess the safety and tolerability of PRX-08066 during the course of therapy.