Positive results for Phase III trial of BAY 63-2521 (Bayer HealthCare) in patients with CTEPH

Data from the Phase III CHEST-1 trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery showed the study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance. In the CHEST-1 study, 261 patients with inoperable CTEPH or with persistent or recurrent pulmonary hypertension after pulmonary endarterectomy were randomized and treated with either riociguat or placebo orally for 16 weeks.

Patients treated with riociguat showed an improvement of 46 meters (95%-CI [25-67 meters]) compared to placebo. The drug also showed statistically significant improvements in secondary endpoints including pulmonary vascular resistance, N-terminal prohormone brain natriuretic peptide and WHO functional class. The results were presented at CHEST 2012, the annual meeting of the American College of Chest Physicians.