Desmoteplase fails DIAS-3 study for Acute Ischaemic Stroke- Lundbeck
Lundbeck A/S announced the initial headline conclusions from DIAS-3 the first of two phase III clinical trials of desmoteplase for the treatment of adult patients with Acute Ischaemic Stroke. The study did not meet the primary endpoint, i.e. the proportion of patients with a favourable outcome of modified Rankin Scale (mRS) score 0-2 at Day 90 was not statistically different between patients treated with desmoteplase (51.3%) and patients in the placebo control group (49.8%).
The DIAS-3 study confirmed the favourable 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.