Date: 2014-06-04
Type of information: Results
phase: 2
Announcement: results
Company: Affiris (Austria)
Product: AD04, AD02
Action mechanism:
Disease: Alzheimer's disease
Therapeutic area: Neurodegenerative diseases
Country:
Trial details:
Latest
news: * On June 4,2014, AFFiRiS announced the results of a phase II study in Alzheimer patients. AFFiRiS\' proprietary compound AD04 is the first drug ever to demonstrate clinical and biomarker effects consistent with disease modification in Alzheimer patients. Upon treatment with AD04, effects consistent with disease modification were achieved for at least 18 months in 47 % of treated patients. This beneficial effect was dose dependent and more effective in early disease patients. Furthermore, prevention of hippocampal decline was correlated with the beneficial impact on clinical progression and was statistically significant. The results show a therapeutic effect of AD04 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 AD02, so far the company\'s lead compound in AD. Dependent on dosage and formulation of AD02 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. Dr. Frank Mattner, CSO and Co-founder, adds: \"Both compounds applied in this trail, AD02 and AD04, showed excellent safety profiles. Top compound AD02 performed very well in stabilization of cognitive functions in a dose dependent manner. 24 – 31 % of treated patients showed stabilization of clinical progression. However, AD04 turned out to be superior to AD02 as 47 % of the patients stabilized regarding their cognitive/ functional status. On top of this, this effect was statistically significantly correlated with the rescue of the hippocampus, the region of the human brain, where cognitive and memory functions are located (p=0.0016). This correlation of significant clinical and biomarker effects meets EMA\'s and FDA\'s definition of disease modification in the context of a compound with a consistent mode of action\". Therefore, Affiris will strongly focus on AD04 for further clinical development.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).
