Phase 1/2a trial commenced for Alzheimer’s dementia immunotherapy
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Key takeaways:
- Trial to assess safety, tolerability, efficacy of ALZN002 in 20 to 30 individuals with mild to moderate dementia.
- ALZN002 is designed to bolster the immune system to reduce beta-amyloid protein burden.
Alzamend Neuro Inc. announced initiation of a phase 1/2a clinical trial for its proprietary immunotherapy vaccineALZN002 to treat mild to moderate dementia associated with Alzheimer’s disease.
According to an Alzamend release, the study will examine safety, efficacy and tolerability of multiple ascending doses of ALZN002 compared with placebo in 20 to 30 individuals with mild to moderate dementia. With the trial, the company aims to determine an appropriate dose of ALZN002 for a larger phase 2b efficacy and safety clinical trial, which should begin within 3 months of data acquisition from the phase 1/2a trial.
“There remains a need to develop new therapies that alter the progression of Alzheimer’s and prevent, reverse or slow neurodegeneration and cognitive decline,” Stephan Jackman, CEO of Alzamend, stated in the release.
ALZN002 consists of autologous dendritic cells — activated white blood cells taken from each patient — that are engineered outside of the body to target AD-related amyloid-beta proteins and, along with a novel amyloid-beta peptide, bolster the patient’s immune system to reduce signs and symptoms of disease, per the release.
“Intermittent use of our immunotherapeutic vaccine (ALZN002) may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease,” Jackman stated in the release.