BioCentury
ARTICLE | Clinical News

Adempas riociguat: Phase IIb discontinued

May 23, 2016 7:00 AM UTC

Bayer discontinued the double-blind, placebo-controlled, international Phase IIb RISE-IIP trial in 147 patients after the study’s IDMC observed that patients receiving Adempas were at a “possible increased risk for death and other serious adverse events” compared to placebo. The company said the IDMC did not identify a cause or common feature among patients who died, though many patients in the Adempas arm “appeared to have more serious and advanced underlying lung disease than the study population as a whole.” Bayer said patients with pulmonary hypertension associated with idiopathic interstitial pneumonia are a high-risk patient population. ...