AFFiRiS Unveil Results For Phase I Alzheimer’s Trial

AFFiRiS’ phase I clinical studies of its two alzheimer’s vaccines AD01 and AD02 met primary endpoints and has demonstrated favourable safety and tolerability profiles.

Reportedly, these results trigger a E10m milestone payment from licensee GSK Biologicals. All 48 patients treated in these studies were given four vaccinations. The results suggested that the studies were well tolerated and no serious side effects associated with the vaccine candidates were observed.

The clinical studies for the two therapeutic Alzheimer’s vaccines were conducted in Vienna, Austria, using two different peptide antigens. 24 patients with mild to moderate stage of the disease were recruited for each of the two studies. Each patient received four vaccinations at four-weekly intervals. Both groups were divided into two subgroups of 12 patients who received the vaccine with or without an adjuvant.

Frank Mattner, CSO of AFFiRiS, said: “All 48 patients were able to complete the study without any problems, with the data now evaluated demonstrating acceptable tolerability of vaccine candidates AD01 and AD02. None of the 48 participants in the studies showed any indications of meningoencephalitis or other autoimmune reactions that have caused severe problems for other Alzheimer’s vaccine candidates. We are now analysing the immunological data and results of the cognitive tests in detail.”

While analysing the clinical outcome in detail the company, together with GSK Biologicals is progressing to the next development stage. AFFiRiS is also using Affitome technology to develop vaccines for Parkinson’s disease, atherosclerosis and four other indications.

Walter Schmidt, CEO at AFFiRiS, said: “This initial demonstration of safety and tolerability is an outstanding milestone in our joint efforts with GSK Biologicals to develop a therapeutic Alzheimer’s vaccination. However, the results also highlight the potential capability of our Affitome technology, which forms the basis for the two vaccine candidates. This technology is also the platform for our six other vaccine programmes, including Parkinson’s and atherosclerosis currently under development. The results not only represent an important milestone in the development of our Alzheimer’s vaccination but also confirm our basic strategy. We will be investing all of this milestone payment in our research and development projects.”