CoTherix has announced data from a Phase II randomized clinical study, designed to evaluate the safety and pilot efficacy of adding Ventavis (iloprost) Inhalation Solution to stable doses of Tracleer (bosentan) in patients with pulmonary arterial hypertension (PAH). These data, from the company's STEP trial (iloprost inhalation solution Safety and pilot efficacy Trial in combination with bosentan for Evaluation in Pulmonary arterial hypertension), were presented at the American College of Chest Physicians meeting in Montreal, Canada.
The data showed that the addition of Ventavis to Tracleer resulted in similar safety trends to those seen in the larger experience of a Phase III study with Ventavis. In addition, data from the secondary endpoints in the STEP study showed an improvement in the six-minute walking exercise test, a reduction in mean pulmonary artery pressure and a delay in clinical deterioration. Clinical deterioration is defined as any of the following: death due to worsening PAH (mortality), receipt of lung transplant or atrial septostomy, hospitalization for worsening PAH, or any early discontinuation from study drug due to worsening PAH.