Desmoteplase: Phase III data
Top-line data from the double-blind, European and Asian Phase III DIAS-3 trial in 479 patients showed that 90 µg/kg IV desmoteplase given 3-9 hours from onset of stroke symptoms missed the primary endpoint of a greater proportion of patients with an 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 (PP) population showed that desmoteplase had a “favorable effect” on mRS score relative to placebo, but the company declined to disclose details. Desmoteplase was well tolerated with mortality and symptomatic intracranial hemorrhage rates comparable to placebo. The trial enrolled patients with symptoms of stroke and treatable ischemic stroke pathology, defined as proximal cerebral vessel occlusion/high-grade stenosis without signs of extensive infarction, intracranial hemorrhage or sub-acute infarction. The company 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. Lundbeck declined to provide a timeline for when data from DIAS-4 are expected. ...