AFFiRiS reports breakthrough in Alzheimer's disease with AD04

Austrian biotech firm AFFiRiS has released Phase II results with its proprietary AD04 vaccine, saying it is the first drug ever to demonstrate clinical and biomarker effects consistent with disease modification in Alzheimer patients.

The results show an impressive therapeutic effect of AD04 and make it the first ever compound demonstrating clinical and biomarker evidence consistent with disease modification of Alzheimer's disease (AD). A statistically significant correlation was demonstrated between the cognitive/functional outcome and the volume of the hippocampus, the region of the brain locating the cognitive/memory functions, both of which demonstrated positive impact on disease progression over 18 months. Similar stabilization was also seen across behavioral and quality of life outcomes.

These results for the very first time meet all of the criteria for disease modification as defined by US and European regulatory agencies - the Food and Drug administration and European Medicines Agency, the company noted.