BioCentury
ARTICLE | Clinical News

Bayer halts Adempas trial on safety concerns

May 13, 2016 12:37 AM UTC

Bayer AG (Xetra:BAYN) said it stopped the 147-patient Phase IIb RISE-IIP study of Adempas riociguat to treat pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP) after the study's independent DMC "observed that patients receiving riociguat were at a possible increased risk for death and other serious adverse events" compared with those receiving placebo.

Bayer said the DMC 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." Spokesperson Rose Talarico declined to disclose details, including the number of deaths in the study. ...