Alzamend Neuro is set to collaborate with Biorasi as its contract research organisation (CRO) for a Phase I/IIA study of autologous amyloid beta mutant peptide-pulsed dendritic cells (ALZN002) in individuals with mild-to-moderate dementia of the Alzheimer’s type.
The first-in-human, double-blind, randomised, placebo-controlled, parallel group trial will evaluate the safety, tolerability, and efficacy of ALZN002.
In the trial, ALZN002’s multiple ascending doses will be compared with a placebo in 20 to 30 subjects with mild-to-moderate dementia.
In addition, the Phase I/IIA trial will determine the optimal ALZN002 dose to treat patients with Alzheimer’s in a larger Phase IIB efficacy and safety study.
This larger trial is expected to start within three months of obtaining results from the initial trial.
ALZN002 is a method using a mutant-peptide sensitised cell as a cell-based treatment vaccine that aims to restore the immunological system ability of a patient to fight Alzheimer’s.
Alzamend Neuro CEO Stephan Jackman said: “We are thrilled to add Biorasi to the team and have full confidence in their ability to conduct our Phase I/IIA clinical trial of ALZN002.
“With the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami manufacturing the vaccine as announced on December 28 2022, Biorasi’s appointment to the team completes all logistics encompassing our ALZN002 clinical trial.
“We are advancing the process and expect to initiate this study by the end of March 2023.”
An ‘active’ immunotherapy product, ALZN002 is produced by the immune system of each patient and comprises autologous dendritic cells, which are activated white blood cells collected from each patient and engineered outside of the body to attack amyloid-beta proteins related to Alzheimer’s.