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Lundbeck's desmoteplase flunks phase III stroke trial

No better than placebo at improving disability symptoms
Lundbeck HQ

Prospects for Lundbeck's stroke therapy desmoteplase are looking shaky after the company reported disappointing data in the first of two phase III trials of the drug.

The results of the DIAS-3 trial indicated that desmoteplase was no better than placebo in improving disability symptoms in stroke patients - as measured by the modified Rankin scale (mRS) - three months after treatment.

The proportion of patients with a score of 0-2 on the mRS scale indicating minimal disability was around 50 per cent in both the desmoteplase and control groups, although Lundbeck suggested a subpopulation of patients did appear to have a benefit.

Desmoteplase is a thrombolytic drug and is designed to work by dissolving blood clots in patients with acute ischaemic stroke (AIS), restoring blood flow and preventing further destruction of brain tissue that has been starved of oxygen.

An older thrombolytic called alteplase (tPA) - sold by Genentech as Activase - is already approved to treat stroke, but remains a controversial therapy as the drug has an extremely narrow therapeutic window and has to be given within three hours of stroke onset. Meanwhile, clinical trials have yielded mixed results, with some showing a benefit and others showing harm.

Lundbeck has been trying to show that desmoteplase is effective when given between three and nine hours from the start of symptoms, a much more realistic option for many stroke cases. The drug is also easier to administer than alteplase as it is given as a single bolus injection, while the older drug requires a bolus followed by an hour-long infusion.

"It is obviously disappointing for us, treating physicians and patients that desmoteplase did not met the primary endpoint in the study," said Lundbeck's head of R&D Anders Gersel Pedersen.

On the positive side there were no safety issues with the drug, particularly with regard to intracranial haemorrhage (ICH), which is a recognised side effect with alteplase and occurs in 3 to 7 per cent of patients.

Given the safety profile and the trend towards a benefit in the subpopulation analysis, Lundbeck is not giving up on desmoteplase just yet.

"Further development will be evaluated with advice from key clinical and regulatory experts during the next few months in order to evaluate if a path forward is feasible," said the company in a statement.

If desmoteplase is dropped the company said it will incur a write-down charge of around 330m Danish krone ($60m) in its accounts for the current financial year.

Desmoteplase is one of a stable of new products Lundbeck is bringing through development to handle the loss of patent protection for antidepressant Lexapro (escitalopram), along with next-generation antidepressant Brintellix (vortioxetine), once-monthly schizophrenia drug Abilify Maintena (aripiprazole) and alcohol dependence therapy Selincro (nalmefene).

Article by
Phil Taylor

30th June 2014

From: Research

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