Results from a Phase II Study to Assess the Clinical and Immunological Activity of AFFITOPE® AD02 in Patients with Early Alzheimer’s Disease
ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a major focus on Alzheimer’s Disease (AD). We are currently preparing for clinical trials in Europe and in the US. Furthermore, ADvantage is developing potentially paradigm-changing therapies to treat AD in its labs at the Vienna BioCenter.MORE ABOUT US Our Breakthrough
Over the last 20 years, Alzheimer’s research concentrated on therapies to produce antibodies against different amyloid-beta peptide species, which were shown to accumulate in the brains of Alzheimer’s patients. However, clinical trial efficacy proved elusive.
Meanwhile, the research team led by Drs. Frank Mattner, Walter Schmidt and Achim Schneeberger developed a (mimotope-based) vaccine, AD02, against amyloid-beta peptides (with a free N-terminus).
In 2014, the team orchestrated a double-blinded, randomized clinical phase 2 trial with AD02 in 332 Alzheimer’s patients. In this trial, Alhydrogel® (now called AD04™) served as a control group.
Unexpectedly, the patients from the control group significantly benefited from the AD04™ application while the AD02 vaccinated groups did not. The shrinkage of the Hippocampus, where memory and orientation are located, was positively impacted by AD04™ treatment coupled with slowdown of cognitive decline.
After several years of negotiation, Frank and Walter bought the patent rights for AD04™. They joined Agustin Fernandez and Jeffrey Madden and founded ADvantage Therapeutics Inc. in order to provide Alzheimer’s patients a transformative, life-enhancing treatment.
*1 The Hippocampus is the part of the brain that harbors memory and orientation functions.
Our product candidate, AD04™, is a known immuno-stimulant: this compound has been widely used as an adjuvant in human and animal vaccination programs and has a well-established safety record. However, injection of this compound as single ingredient for the treatment of AD is a proprietary approach.
What results have you seen that support the clinical development of AD04™?
Our data obtained in patients with early AD indicated that AD04™, applied repeatedly to the subcutis of the upper arm induced a statistically significant slower decline over the combined 4 other groups on clinical outcomes (e.g. cognition and quality of life) and MRI hippocampal volume as biomarker. Importantly, reduced loss of the hippocampal volume correlated with significantly less decline in cognitive measures, e.g., adapted Alzheimer’s Disease Assessment Scale-cognitive (aADAS-cog), but not in functional endpoints supporting AD04™ as a therapeutic entity (see “Summary of Phase 2”).
AD04™ tested in the respective clinical trial arm (n=51 patients) was safe and well tolerated. There was neither evidence for autoimmunity nor for hematological abnormalities or hepato-/nephrotoxicity.MORE ABOUT OUR SCIENCE Our Pipeline