Therapeutics

ALZ-101

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Overview

Name: ALZ-101
Therapy Type: Immunotherapy (active) (timeline)
Target Type: Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 1)
Company: Alzinova AB

Background

This candidate vaccine is designed to provoke an immune response specific to soluble oligomeric Aβ assemblies, but not to monomeric or fibrillar Aβ. A proprietary protein-engineering technology uses disulfide bonds to cross-link Aβ peptides into a conformation that assembles into stable, soluble oligomers or protofibrils (Sandberg et al., 2010, Dubnovitsky et al., 2013). These assemblies are formulated into the ALZ-101 vaccine.

No preclinical work on ALZ-101 has been published.

Findings

In September 2021, Alzinova began a Phase 1b study in Finland to evaluate tolerability, safety and immunological response to the vaccine. The blinded study will enroll 26 patients with CSF biomarker-confirmed early AD to receive four intramuscular injections of 125 or 250 μg ALZ-101 or placebo over 20 weeks. Primary endpoints are adverse events, especially injection related events, amyloid-related imaging abnormalities, and cognitive or functional worsening in the year after vaccination. Secondary outcomes relate to Aβ-specific antibody responses. Exploratory endpoints are blood and CSF AD biomarkers. The trial will run through July 2023 (see press release and trial design slide on company website).

For trial details, see clinicaltrials.gov.

Last Updated: 13 May 2022

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References

Paper Citations

  1. . Stabilization of neurotoxic Alzheimer amyloid-beta oligomers by protein engineering. Proc Natl Acad Sci U S A. 2010 Aug 31;107(35):15595-600. PubMed.
  2. . Amyloid-β protofibrils: size, morphology and synaptotoxicity of an engineered mimic. PLoS One. 2013;8(7):e66101. PubMed.

External Citations

  1. press release
  2. trial design slide
  3. clinicaltrials.gov

Further Reading

Papers

  1. . Amyloid-β protofibrils: size, morphology and synaptotoxicity of an engineered mimic. PLoS One. 2013;8(7):e66101. PubMed.
  2. . Amyloid-β protofibrils: size, morphology and synaptotoxicity of an engineered mimic. PLoS One. 2013;8(7):e66101. PubMed.