Actelion announces ‘successful’ Tracleer study

Actelion has presented the results of the endothelin antagonist trial in mildly symptomatic pulmonary arterial hypertension (PAH) patients. The trial showed that patients administered with Tracleer (bosentan) for six months exhibited a significant reduction in pulmonary vascular resistance.

Tracleer is an orally administered dualendothelin receptor antagonist currently available in the US, EU and elsewhere in the world for the treatment of patients with PAH.

Isaac Kobrin, head of development at Actelion, said that he was “pleased” that the compound had shown a delay in clinical worsening in patients with mild PAH symptoms with their exercise capacity well preserved.

“Also, in this population, we observe a significant reduction in pulmonary vascular resistance, a measurement gained by a direct invasive procedure and considered to be a robust indicator of disease severity.”

He added that approval of PAH drugs by regulators is focused on significant symptomatic changes in patients, with such changes being observed by patients administered with Tracleer taking the six-minute-walk test, despite the existing well-preserved exercise capacity.

Earlier this month, Actelion announced the start of a phase III programme investigating the tissue targeting endothelin receptor antagonist Actelion-1 for the treatment of pulmonary hypertension and other indications.