Lundbeck's desmoteplase misses primary endpoint in Ph III stroke study

Danish CNS specialist Lundbeck (LUND: CO) released disappointing initial headline conclusions from DIAS-3, the first of two Phase III clinical trials of desmoteplase for the treatment of adult patients with acute ischemic stroke.

The study did not meet the primary endpoint, ie, the proportion of patients with a favorable outcome of modified Rankin Scale (mRS) score 0-2 at Day 90 was not statistically different between patients treated with desmoteplase (51.3%) and those in the placebo control group (49.8%). Lundbeck’s shares rose 2.4% to 147.40 Danish kroner by close of trading on Friday.

The DIAS-3 study confirmed the favorable safety profile of desmoteplase by providing excellent safety and tolerability data. Desmoteplase was well tolerated with adverse events at placebo level. In particular, the mortality was equal between treatment groups and the rate of symptomatic intracranial haemorrhage (the most serious adverse event associated with the current available thrombolytic treatment) after desmoteplase treatment was also comparable to placebo.