AFFiRiS, Michael J. Fox Foundation Report Positive Results On PD01A Parkinson's Vaccine
By Cyndi Root
AFFiRiS announced in a press release that a study on PD01A, a Parkinson’s disease vaccine, has shown positive results. The research, sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), met its primary endpoint as two different doses of PD01A were well tolerated and safe. AFFiRiS and MJFF intend to conduct a follow-up study in Vienna, Austria starting in September on the immunological and clinical effects of a boost vaccination, and then proceed to Phase II trials.
Walter Schmidt, PhD, Co-founder and CEO of AFFiRiS, said, "The safety and tolerability observed in this study, especially in a protein such as alpha-synuclein where we do not yet know its normal function, are encouraging. We are grateful for the continued support of The Michael J. Fox Foundation as we progress in clinical development."
PD01A
AFFiRiS' proprietary therapeutic vaccine, PD01A, was evaluated in the AFF008 trial. PD01A is an immunotherapy vaccine against Parkinson’s disease that targets the protein alpha-synuclein. The agent produces alpha-synuclein-specific antibodies that are measurable in serum samples and cerebrospinal fluid. MJFF CEO Todd Sherer, PhD., said of the study results, "A treatment that could slow or stop Parkinson’s progression would be a game changer for the five million worldwide living with this disease and the many more who will become at risk as our population ages.”
The primary endpoint of the trial was safety and tolerability. The secondary endpoint was the alpha-synuclein-specific antibody response. Since alpha-synuclein protein aggregation in the brain cells is a hallmark of Parkinson’s disease, researchers hope that reducing alpha-synuclein accumulation will protect the brain and modify the disease.
In the study, researchers gave 15 µg and 75 µg of PD01A to 12 patients and followed with three more vaccinations at monthly intervals. All participants were evaluated for 12 months and were compared with a control group that had continued taking their usual care treatment, including standard medications. Researchers found that PD01A patients functionally stabilized compared to the control group and improved consistently in all parameters.
About AFFiRiS
AFFiRiS AG is an Austrian company based in Vienna, supported with investments from MIG-Fonds, Athos Service GmbH, and MJFF. The company focuses on immunotherapies and peptide-based agents. It works in Alzheimer’s, Parkinson’s, diabetes, and other diseases and conditions.