Name: Affitope AD02
Therapy Type: Immunotherapy (active) (timeline)
Target Type: APP and Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2)
Company: AFFiRiS AG, GlaxoSmithKline (GSK)
Affitope AD02 is a synthetic peptide of six amino acids that mimics the N-terminus of Aβ. AFFiRiS hypothesizes that this fragment enables exclusive recognition of Aβ without cross-reacting with APP, and hence may have a favorable safety profile. This immunogen is short and non-self. Lacking the most common T cell epitope (within amino acids 15–42 of Aβ) but including the B cell epitope (within the first 11–15 amino acids of Aβ), it may allow for the production of anti-Aβ antibodies while minimizing a pro-inflammatory TH1 response.
A Phase 1 study conducted in Austria tested subcutaneous AD02 alone and with aluminium hydroxide adjuvant in 24 patients with mild to moderate Alzheimer's disease. It showed a favorable safety and tolerability profile at one year. No meningoencephalitis was reported. Phase 1b extensions tested booster doses, immunogenicity, and tolerability at two years. A 300-patient, multicenter Phase 2 trial of AD02 without adjuvant in patients with early AD is expected to finish in 2014. See all AD02 trials listed in clinicaltrials.gov.
Clinical Trial Timeline
- Phase 2
- Study completed / Planned end date
- Planned end date unavailable
- Study aborted
- Schneeberger A, Mandler M, Otawa O, Zauner W, Mattner F, Schmidt W. Development of AFFITOPE vaccines for Alzheimer's disease (AD)--from concept to clinical testing. J Nutr Health Aging. 2009 Mar;13(3):264-7. PubMed.
- Schneeberger A, Mandler M, Mattner F, Schmidt W. AFFITOME® technology in neurodegenerative diseases: the doubling advantage. Hum Vaccin. 2010 Nov;6(11):948-52. PubMed.