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.
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.
Dr Walter Schmidt, CEO and co-founder of the company, has explained the company's 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.’
Dr Frank Mattner, CSO and co-founder, added: ‘It is part of our strategy in the early phase of vaccine development to focus on more than one candidate, if possible. In this way, we diversify our risk. Based on this, we can then back in the first instance the potentially most promising candidate and put the others on hold. This is exactly what we did with our Alzheimer's vaccination program and the outcome in the Phase I trials at this stage enabled us to make this decision earlier than we expected and to offer a booster vaccination to the AD02-treated patients. Finally, we can also redirect our resources which will now be available for our other vaccination programs.’ AFFiRiS AG can also invest all of the €10 million, paid by licensing partner GSK Biologicals as a milestone payment for the positive completion of the Phase I studies, in the other R&D programmes.
The vaccine development programme of AFFiRiS is based on the company's AFFITOME technology, which also delivered the vaccines tested so far. Also based on this technology are six other vaccination programmes being developed by AFFiRiS AG, which target (among other indications) Parkinson's disease and atherosclerosis.