Shares of pharma firm H. Lundbeck A/S (HLUKY.PK, HLUKF.PK) declined around 7 percent in Copenhagen on Monday, following an update by the company on Friday that its late-stage study of desmoteplase, for the treatment of adult patients with acute ischaemic stroke, did not meet the primary endpoint.
Desmoteplase is a fibrin-dependent plasminogen activator, 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 U.S. Food and Drug Administration for the treatment of acute ischaemic stroke.
DIAS-3 was the first of two phase III clinical trials of desmoteplase for this indication.
It was a multi-center, randomized, double-blind, placebo-controlled study in 479 patients from 18 countries in Europe and Asia.
Patients with symptoms of stroke and a treatable ischaemic stroke pathology, as assessed by magnetic resonance imaging or computerised tomography scanning, were randomized to receive either desmoteplase 90 µg/kg or placebo within three to nine hours of symptom onset.
The study showed that the proportion of patients with a favorable outcome of modified Rankin Scale or mRS score 0-2 at Day 90 was not statistically different between patients treated with desmoteplase and patients in the placebo control group.
The DIAS-3 study confirmed the favorable safety profile of desmoteplase and it was well tolerated with adverse events at placebo level.
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.
Considering the failure to meet the primary outcome as well as the efficacy signal in the per protocol population and the excellent safety and tolerability, the company will evaluate further development.
Further, the company said the trial miss would have no influence on its financial guidance on revenue or core earnings before interest and tax for 2014.
The status of the desmoteplase program is dependent on the internal and external evaluation during the next few months. If the outcome of this evaluation is negative a write-down of 330 million Danish kroner will be recognised in the R&D cost line as the firm had previously informed.
The stock declined 6.9 percent to 137.30 kroner.
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