In the trial, AD04 showed clinical and biomarker effects consistent with disease modification in Alzheimer patients.
Following treatment with AD04, effects consistent with disease modification were achieved for at least 18 months in 47% of treated patients and this effect was dose dependent and more effective in early disease patients.
In addition, prevention of hippocampal decline was correlated with the beneficial impact on clinical progression and was statistically significant.
Therefore, the results for the very first time meet all of the criteria for disease modification as defined by US and European Regulatory Agencies FDA and EMA.
The company said that a statistically significant correlation was showed 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.
AFFiRiS CEO and co-founder Walter Schmidt said the results show that AD04 is the first drug ever to show disease modifying properties in Alzheimer’s patients.
"This success is owed to our strategy of clinical maturation, which in the case of Alzheimer’s has so far moved forward four different product candidates namely AD01 – AD04 into clinical development."