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Roche and Evotec’s Alzheimer’s drug ineffective

Sembragiline failed to show cognitive and memory benefits

Alzheimer's disease brain scanThe quest for an effective therapy for Alzheimer's disease seems to have claimed another casualty, with a drug developed by Evotec and Roche flunking a phase II trial.

Roche reports that sembragiline – a drug in the monoamine oxidase type B (MAO-B) inhibitor class – was unable to show a significant benefit on the cognitive and memory deficits in Alzheimer's patients in the year-long MAyflOwer RoAD study.

The trial involved patients with moderate Alzheimer's who were randomised to receive either sembragiline or placebo on top of background therapy with one of the four approved drugs for the disease – the cholinesterase inhibitors donepezil, galantamine and rivastigmine or glutamate NMDA receptor antagonist memantine.

Roche has not yet revealed whether it intends to drop the drug from development, but there was an air of finality in Evotec's statement on the disappointing data, with chief executive Werner Lanthaler emphasising that the company still has “more than 70 product opportunities within our portfolio in the fields of CNS and pain, metabolic diseases, oncology and anti-infectives.”

The results of the study are particularly disappointing as sembragiline is one of only a handful of drugs in development for Alzheimer's that are addressing mechanisms other than trying to block the formation of the amyloid plaques that are found in the brains of patients with the disease.

MAO-B levels are known to be elevated in the central nervous system of patients with Alzheimer's and other neurodegenerative disorders such as Parkinson's disease. As the enzyme is involved in the creation of reactive molecules that can damage cells and increase with age, it has been hypothesised that it plays a role in both diseases as well as age-related cognitive decline.

There are already drugs on the market for other indications that act via MAO-B inhibition – including generic selegiline and Teva's Azilect (rasagiline) – but to date these drugs have not been shown to have much efficacy in Alzheimer's.

A meta-analysis of trials studying selegiline in the disease concluded there was scant evidence for efficacy. Last year, the Alzheimer's Drug Discovery Foundation (ADDF) raised more than $1m expressly to support a trial that will see whether rasagiline can be re-purposed to treat Alzheimer's as well as Parkinson's disease. 

Roche and Evotec formed an alliance in 2011 for the development of the MAO-B inhibitor, which included a $10m upfront payment and potential milestones of $820m. The compound was originally licensed from Roche to Evotec in 2006 for a different indication and was Evotec's most advanced clinical project.

Article by
Phil Taylor

1st July 2015

From: Research

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