AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company based its fast decision on the first interim analysis of the secondary endpoints at the six month time point. Furthermore, based on this analysis, the AD02 patients from the completed Phase I study will now be offered an AD02 booster vaccination.
AFFiRiS AG announced today, that Alzheimer's vaccine candidate AFFITOPE AD02 will undergo immediate tests for potential efficacy in a Phase II trial. This means that the company can focus its diversified development program for Alzheimer's vaccines earlier than initially planned. The reason for the decision is based on the interim analysis of the preceding Phase I testing.
Dr. Walter Schmidt, CEO and co-founder of the company, explains the company's surprisingly rapid decision: "Both vaccines AD01 and AD02 met the primary phase I endpoints demonstrating safety and tolerability and therefore both qualified for phase II testing. However, as a small biotech with a strong focus on optimized resourcing, we are always keen to prioritize. Based on the first interim analysis of secondary endpoints, which is confidential at this stage, we decided to focus in the first instance on AD02. The Phase II trial will start as early as possible, hopefully early next year."