Actelion reports strong Ph II data with selexipag; says REVEAL study may advance patient care in PAH

Swiss biotechnology firm Actelion says that full data from the Phase II study of selexipag (proposed INN), the company's first-in-class, orally-available, selective IP receptor agonist in patients with pulmonary arterial hypertension (PAH) were presented by Gerald Simonneau, Chief of the Department of Pneumology, Hospital Antoine Beclere, Clamart, France, and Lead investigator on the trial, during the American Thoracic Society's 2010 international conference taking place this week in New Orleans, USA.

Results of the 43-patient, placebo-controlled, double-blind study, where patients were randomized in a 3:1 ratio receiving selexipag or placebo, showed a statistically significant reduction in pulmonary vascular resistance (PVR; primary parameter for the study). The treatment effect was shown to be 30.3% after 17 weeks of treatment (p=0.0045). Results also showed an encouraging numerical improvement in six-minute walk distance (6MWD), which was a secondary endpoint of this trial. Selexipag was well tolerated and the safety profile was in-line with the expected pharmacologic effect.

Prof Simonneau commented: "These Phase II results are very encouraging, particularly considering that the efficacy observed is on top of oral background therapy. They strongly support the study of this very promising oral IP receptor agonist in the ongoing Phase III study."