Predix phase 1b study indicates PRX-08066 reduces hypoxia-induced pulmonary blood pressure

By Lisa Kerner

Erie, Pa., April 19 - Predix Pharmaceuticals completed a phase 1b clinical trial to study the pharmacodynamics and tolerability of its 5-HT2B selective antagonist, PRX-08066, in 15 adults conditioned to exercise at high altitudes, with elevated pulmonary artery pressures induced by low oxygen levels (hypoxia).

In the randomized, double-blind trial, each subject received drug or placebo twice daily for 3 days in three separate periods, with an interval of approximately 2 weeks between visits.

Subjects were challenged with hypoxic conditions for 90 minutes to induce increases in pulmonary blood pressure during each dosing day.

A reduction in the systolic pulmonary blood pressure during resting hypoxia and during exercise hypoxia was observed with PRX-08066 treatment, at a dose level of 200 mg given orally bid (twice daily).

Of the 15 subjects who received at least one dose of study drug, 10 completed all phases of the trial.

The preliminary results indicate that in a human model for pulmonary hypertension, PRX-08066 significantly reduces pulmonary artery blood pressure during hypoxic exercise without affecting systemic blood pressure.

Predix is developing PRX-08066 to provide symptomatic improvement through selective dilation of diseased pulmonary blood vessels and to slow disease progression by inhibiting the thickening of the pulmonary artery vessels.

PRX-08066 has demonstrated selective pulmonary vasodilation in both acute and chronic animal models of pulmonary hypertension, as well as potential disease-modifying effects in in vitro biochemical pathway studies.

Predix is a pharmaceutical company based in Lexington, Mass.

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