Actelion’s Opsumit drug missed a primary endpoint in a late-stage study of patients with pulmonary arterial hypertension due to Eisenmenger Syndrome, a doctor involved in the trial said in a statement from the Swiss drugmaker.
ZURICH Actelion’s Opsumit drug missed a primary endpoint in a late-stage study of patients with pulmonary arterial hypertension due to Eisenmenger Syndrome, a doctor involved in the trial said in a statement from the Swiss drugmaker.
Actelion has been doing the Phase III trial amid its push to expand the clinical use of Opsumit — its follow-on medicine to blockbuster PAH drug Tracleer that has lost patent protection — for patients suffering from different forms of the deadly heart-lung ailment.
Falling short of the trial’s primary endpoint — exercise capacity as measured in a six-minute walk test — could limit Opsumit’s revenue potential that is seen as one reason U.S. healthcare giant Johnson & Johnson J&J.N has been engaged in weeks of exclusive talks to acquire Actelion.
“Although the results point towards a benefit of treatment with macitentan (Opsumit), we do not see a significant treatment effect on the primary endpoint of exercise capacity as measured in the 6 minute walk test,” said Nazzareno Galie, head of the Pulmonary Hypertension Center at the University of Bologna’s Institute of Cardiology.
The result may have been influenced by an “unexpected improvement” in the study’s placebo arm, Galie said, adding that researchers must “fully analyze the data to understand what could have caused this phenomenon”.
Actelion shares were seen falling 1.4 percent on Monday, according to pre-market indicators.
(Reporting by John Miller- Editing by Michael Shields)
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