Model ALZ-101 - Vaccine that Stimulates the Production of Antibodies against the Toxic Aß Oligomers

Several clinical setbacks within anti-amyloid methods to treat Alzheimer’s disease have highlighted that non-clinical in vivo efficacy studies in transgenic disease models alone cannot prove a drug’s potential. Alzinova has therefore complemented the early selection process with in vitro and ex vivo pharmacology studies utilizing patient-derived toxic material.

In brief, the selection of ALZ-101 was based on three important criteria:

1. Specificity for the CNS-specific oligomeric forms has been demonstrated in vitro.
2. Information of potential efficacy has been obtained by assessing the direct toxic effect(s) of brain material, and neutralizing this effect ex vivo.
3. Target engagement in the CNS has been demonstrated in vivo using a preclinical efficacy model (transgenic mice) which focused on relevant markers of oligomer-pathology.

This combined information serve as a good indicator of ALZ-101’s potential efficacy.

ALZ-101 has also proven to be immunogenic. It generates an immune response that is not associated with any findings suggestive of systemic toxicity in mice, rabbits and non-human primates. A GLP-compliant toxicology and safety pharmacology study in non-human primates demonstrated that it was clinically well tolerated in this species.