Model ALZ-101 - Vaccine that Stimulates the Production of Antibodies against the Toxic Aß Oligomers
ALZ-101 is a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers. A first-in-human study in patients with early Alzheimer’s disease was initiated during third quarter of 2021.
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Preclinical Development
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:
- Specificity for the CNS-specific oligomeric forms has been demonstrated in vitro.
- Information of potential efficacy has been obtained by assessing the direct toxic effect(s) of brain material, and neutralizing this effect ex vivo.
- 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.
Clinical Development
Alzinova has designed a first-in-human clinical study to evaluate the safety and immunogenicity of ALZ-101. Exploratory endpoints are biomarkers in cerebrospinal fluid (CSF) and serum and preliminary efficacy measured with a package of psychometric tests.
Our goal is that patients will be recruited in the ongoing clinical trial over a 12-month period. The results of the study are expected to be available in the second half of 2023. Please return later for more information and updates.
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