Actelion's ERA drug enters Ph III testing

Swiss biotechnology firm Actelion has initiated a Phase III study assessing its tissue-targeting endothelin receptor antagonist Actelion-1 (ACT-064992). The SERAPHIN trial is designed to evaluate the safety and efficacy of the agent in delaying disease progression and mortality in patients with pulmonary arterial hypertension.

SERAPHIN is a global evaluation that will enroll more than 500 patients from at least 180 centers, randomized to receive two different doses of Actelion-1 (3mg and 10mg once daily) or placebo. The trial will evaluate the clinical benefit of the agent through the primary endpoint of morbidity and all-cause mortality in patients with symptomatic PAH.