Affiris AD02 vaccine to enter Phase II in April
Austrian Affiris AG’s (Vienna) short peptide AD02, which mimics the N-terminal portion of the Ab 40-42-peptide, has met its safety endpoints and shown the first signs of efficacy in a Phase I trial with 12 Alzheimer patients and 12 healthy controls. According to CEO Walter Schmidt, only mild to moderate adverse events like pain at the injection site and itching were observed. Additionally, nine of 12 patients vaccinated with AD02 plus aluminumhydroxide as an adjuvant led to the stabilisation of cognitive capabilities over 18 months. AD02 also provided the first signs of disease stabilisation that seemed to correlate with higher titres of antibodies induced by the substance. However, the number of enrolled patients was too low to provide statistical significance. In April, Affiris was just preparing the start of Phase II trials with 420 volunteers to back up the results.