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The Editors blog

An inside look at what’s happening within the pharma industry and across the PMGroup from the PMLiVE editorial team

Burden of proof

Breakthroughs in Alzheimer's are sorely needed, but there's still lots of work to do on AD04
Alzheimers brain scan

Responsible for more than 60 per cent of dementia cases in Europe, Alzheimer's disease is an area desperately in need of treatment advances.

So AFFiRiS' recently announced 'breakthrough' should be a cause for celebration. But the Vienna-based biotech faces some hasty repositioning after AD02, its lead peptide-based vaccine, was beaten in a phase II trial by its AD04 comparator.

The results indicate AD04 is “the first drug ever to demonstrate clinical and biomarker effects consistent with disease modification”, according to the company, which says its effects were achieved for “at least 18 months in 47 per cent of patients”.

Breakthrough or not, AD04 still faces an uphill struggle. Drugs designed to dissolve or block the formation of amyloid plaques have consistently failed in late-stage clinical trials, often after encouraging results on cognitive measures in phase II.

And although AFFiRiS says AD04's results are the first ever to meet EMA and FDA criteria for disease modifications in Alzheimer's, the trial was not a controlled study and had no placebo group.

So a wait-and-see approach remains prudent - only further, rigorous testing will tell if AD04 really is a breakthrough.

Article by
Dominic Tyer

editorial director of PMGroup

6th June 2014

From: Research

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