The study indicated that six months of treatment with Tracleer showed a significant reduction in pulmonary vascular resistance, a primary endpoint of the study. Patients also showed a strong trend towards improvement in 6-minute-walk test compared to placebo, another primary endpoint.
The study met its main secondary endpoint, as treatment with Tracleer was associated with a significant delay in time to clinical worsening compared to placebo, representing a 70% reduction in risk. In this study, Tracleer's safety and tolerability profile was consistent with that observed in previous clinical trials.
The company will now fully analyze the data in anticipation of planned upcoming regulatory filings worldwide to expand the Tracleer indication to include mildly symptomatic pulmonary arterial hypertension (PAH) patients.
“Currently, regulatory approval of PAH drugs focuses on significant symptomatic changes. In this study where patients presented on average with well-preserved exercise capacity at baseline, the six-minute-walk test nevertheless showed a strong trend towards significance. More importantly, Tracleer has consistently demonstrated its unique ability to delay time to clinical worsening, the ultimate treatment goal,” concluded Isaac Kobrin, head of Development of Actelion.