BioCentury
ARTICLE | Clinical News

Lundbeck's desmoteplase misses in ischemic stroke

June 27, 2014 11:50 PM UTC

H. Lundbeck A/S (CSE:LUN) said IV desmoteplase given 3-9 hours from onset of stroke symptoms missed the primary endpoint vs. placebo in the Phase III DIAS-3 trial to treat acute ischemic stroke. Desmoteplase did not lead to a greater proportion of patients with a modified Rankin Scale (mRS) score of 0-2 points at day 90 vs. placebo (51.3% vs. 49.8%). Lundbeck said data from only patients in the per protocol population showed desmoteplase had a "favorable effect" on mRS score relative to placebo, but declined to disclose details. The trial enrolled 479 patients with symptoms of stroke and treatable ischemic stroke pathology.

Lundbeck said it will consult with clinical and regulatory experts during the next few months about the future of desmoteplase, which is also in the Phase III DIAS-4 trial to treat acute ischemic stroke. Desmoteplase is a genetically engineered fibrin-dependent salivary plasminogen activator from the vampire bat Desmodus rotundus. ...