Lundbeck has initiated a clinical phase III programme with desmoteplase in the treatment of acute ischemic stroke.
The programme consists of two phase III clinical placebo-controlled trials, each enrolling approximately 320 patients.
Approximately 80% of stroke patients are not diagnosed and ready for treatment until more than three hours after the stroke takes place. The only currently approved medical treatment for patients suffering from stroke must be applied within a maximum of three hours after the stroke takes place.
Following consultations with health authorities the trials have been designed with the aim of measuring efficacy of one dosage of desmoteplase (90mg/kg) administered in a window of between three and nine hours after the stroke has occurred.
The two trials will enrol patients internationally at sites in Europe, USA, Canada, South America and Asia. The efficacy of desmoteplase will be assessed after 90 days.
“Desmoteplase has the potential to treat patients with acute ischaemic stroke up to nine hours after onset of symptoms. That is up to six hours more than existing treatment and will allow a large group of patients time to reach the hospital and be treated”, says Executive Vice President Anders Gersel Pedersen, Head of Development at Lundbeck. “Desmoteplase has the potential to become a significant benefit to patients in an area with substantial unmet medical needs.”
Desmoteplase, the most fibrin-specific plasminogen activator known today, is a genetically engineered version of a clot dissolving protein found in the saliva of the vampire bat Desmodus rotundus. It has received fast track designation from the US Food and Drug Administration for the indication of acute ischemic stroke.