Breakthrough in Alzheimer's disease

AFFiRiS halted clinical progression in Alzheimer patients upon treatment with AD04 in a phase II clinical study

06-Jun-2014 - Austria

AFFiRiS AG released for the first time results of a clinical phase II study in Alzheimer patients of its proprietary compound AD04, a therapeutic drug against Alzheimer's disease. 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. 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.

Commenting on these results Dr. Walter Schmidt, CEO and Co-founder of AFFiRiS AG, states: "Our results demonstrate 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 has so far moved forward four different product candidates namely AD01 – AD04 into clinical development."

https://www.bionity.com/en/news/148579/breakthrough-in-alzheimer-s-disease.html