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.
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