Opsumit macitentan: Additional Phase III data

Additional data from the double-blind, international Phase III SERAPHIN trial in 742 patients with symptomatic PAH showed that once-daily 3 and 10 mg oral Opsumit each reduced the composite of time to first morbidity or mortality event, the primary endpoint, irrespective of background PAH therapy vs. placebo. In the presence of background PAH therapy, low-dose Opsumit reduced the risk of a morbidity or mortality event, defined as death, atrial septostomy, initiation of IV or subcutaneous prostanoids, lung transplantation or other worsening of PAH, by 17% compared to placebo, while high-dose Opsumit reduced the risk by 38%. In the absence of background PAH therapy, low-dose Opsumit reduced the risk by 47% compared to placebo, while high-dose Opsumit reduced the risk by 55%. Background PAH therapy included phosphodiesterase-5 (PDE-5) inhibitors and oral/inhaled prostanoids. Additionally, low-dose Opsumit reduced the risk of either death due to PAH or hospitalization due to PAH, a secondary endpoint, by 33% compared to placebo (p=0.0146), while high-dose Opsumit reduced the risk by 50% (p<0.0001). Data will be presented at the American College of Chest Physicians meeting in Atlanta this week. ...