Phase II trial of AD 04 shows benefits in Alzheimers - AFFiRiS

AFFiRiS AG has released results of a clinical Phase II study in Alzheimer patients of AD 04. The results show an impressive therapeutic effect and make it the first ever compound demonstrating clinical and biomarker evidence consistent with disease modification of Alzheimer's disease. 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.

There was also a stabilization of the cognitive/functional endpoint found in those patients of this study who were treated with AD 02, so far the company's lead compound in AD. Dependent on dosage and formulation of AD 02 in three different study arms, 24-31% of the patients showed cognitive/functional stabilization or improvement. However, statistically significant correlation with biomarker Hippocampus volume could not be demonstrated within the observation period of 18 months. Altogether 332 patients were treated in an international multi-centric clinical trial into five different study arms, and over 85% completed the study. Therefore, these results for the very first time meet all of the criteria for disease modification as defined by US and European Regulatory Agencies FDA (Food and Drug administration) and EMA (European Medicines Agency).