AFFiRiS' Alzheimer's vaccination shows promising results

15-Mar-2011 - Austria

AFFiRiS' Alzheimer's vaccine candidate AD02 showed indicative evidence for potential efficacy in a phase I clinical trial. This was demonstrated by the analysis of the data from secondary clinical study endpoints. AFFiRiS AG previously announced that their Alzheimer vaccine candidate AD02 met the primary endpoints of phase I clinical testing by demonstrating safety and tolerability. 24 subjects were vaccinated, 12 received the vaccine with adjuvant and 12 without.

The recently completed analysis from this study of secondary clinical endpoints of AD02 based treatment - regarding cognitive performance of the subjects, body weight development and vaccine induced immune responses - suggests evidence for potential disease modifying activity of this vaccine candidate.

CEO and co-founder of AFFiRiS, Dr. Walter Schmidt, comments: "We really observed some positive results from this phase I trial. Most important was the stabilisation of the cognitive capabilities of 9 out of 12 subjects treated with the adjuvanted AD02 formulation over the complete observation period of 18 months. During the clinical trial all adverse events were mild to moderate in nature, like pain at the injection site and itching."

These Phase I results indicated a surprisingly robust and persistent stabilisation of the cognitive functions. The subjects' cognitive decline did not occur as expected from the natural course of disease. Furthermore, a boost vaccination was applied and the positive trend was prolonged.

The obtained disease stabilisations were related to the subjects' MMSE values at study entry. It became evident that patients with a MMSE score of 20 and above were found to have stable scores at the end of the study, while this could not be observed for the study participants with an entry score below 20.

These results were further supported by findings from the development of the body weight of the subjects. This is a potential biomarker that has hardly been considered in clinical studies in the past. Typically, Alzheimer patients lose weight during the course of their disease. Their sense of taste might be disturbed or they might just simply forget to eat. In contrast, patients treated with adjuvanted AD02 experienced a stabilisation of their body weight.

Finally, the analysis of the immunological data regarding antibody titers induced upon vaccination further supported the possible correlation between AD02 based vaccination and the observed stabilisation of cognitive functions.

Since the end of last year, vaccine candidate AD02 is in clinical phase II testing designed to evaluate the efficacy in Alzheimer patients. The study design already takes into account the indicative results of the phase I study. The study is currently in the recruitment phase with 30 study centers in Austria, Germany, France, Croatia and Slovakia (Czech Republic in preparation) being involved. A total of 420 patients will be included (http://klinische-studien-vienna.info/). Preliminary results regarding this study are expected to be available by the end of 2012.

https://www.bionity.com/en/news/131317/affiris-alzheimer-s-vaccination-shows-promising-results.html