Lundbeck scraps stroke drug
pharmafile | December 18, 2014 | News story | Research and Development, Sales and Marketing | AIS, DIAS, Lundbeck, acute ischemic stroke, desmoteplase, stroke
Lundbeck has stopped development of its investigational stroke drug desmoteplase following disappointing results from its Phase III studies.
The DIAS-3 trial suggested that in most patients the drug had no benefit over placebos in reducing disability symptoms associated with acute ischemic stroke (AIS).
Although Lundbeck said that a few patient subgroups in both this trial and the more recent DIAS-4 study did see some benefits, it now concedes that it is “insufficiently clear how to select patients in future prospective studies” and will not continue with the trials.
The Danish firm adds that alternatives for the drug are now being evaluated, including the possibility of selling it to another company.
Desmoteplase is a genetically engineered version of a clot-dissolving protein found in the saliva of vampire bats. It is designed to restore blood flow in patients who have recently suffered from AIS to stop the brain being starved of oxygen and becoming damaged.
The drug had previously received fast-track designation from the FDA. It was hoped that it could provide an alternative to Genentech’s Activase (alteplase), which has a similar function but has shown mixed safety results in trials and has to be administered within three hours of the stroke.
Although desmoteplase has been shown to have a good safety profile, the proportion of patients in the Phase III trials who scored 0-2 on the modified Rankin scale (mRS) for disability was around 50% in both placebo and desmoteplase groups, three months after treatment.
As a result of the decision to drop the drug, Lundbeck will incur a write-down charge of 309 million Danish kroner ($51 million) in the fourth quarter of 2014.
The firm has also altered its financial guidance for 2014, lowering its expected reported profit from 0-0.5 billion kroner ($0-83 million) to 0-0.2 billion kroner ($0-33 million). It still expects its constant exchange rate revenue to be around 13.5 billion kroner ($2 billion), though.
George Underwood
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