Phase 2b trial of AD04 in mild Alzheimer’s enrolls first patient
Study’s main goal is to evaluate changes in cognitive function
A proof-of-concept Phase 2b clinical trial evaluating the safety and efficacy of Advantage Therapeutics’ investigational immunotherapy AD04 in people with mild Alzheimer’s disease has enrolled its first patient.
The placebo-controlled study is being conducted in Austria, France, Poland, Bulgaria, and Slovakia, and is expected to open clinical sites in Germany and the U.K. The first patient was enrolled at the Institut Neuromed in Korneuburg, Austria.
“Inclusion of this first patient is representative of many years and many dedicated professionals collaborating toward the common goal of better treating Alzheimer’s disease,” Achim Schneeberger, MD, chief medical officer of Advantage, said in a company press release. “We look forward to continuing our collaboration with the European regulatory agencies and the clinical sites to populate this important trial.”
Alzheimer’s “represents a significant global problem as the adult population is aging which further challenges our ability to care for those who suffer from this terrible, progressive disease,” said Andreas Winkler, MD, the trial’s principal investigator at Institut Neuromed. “AD04 represents a significant departure from approaches seen to date and one that may change our understanding of how to manage it as well as the disease itself. We look forward to continuing to participate in the trial to help contribute to its development.”
Alzheimer’s is a progressive neurodegenerative disorder believed to be caused by the toxic accumulation amyloid-beta and tau protein aggregates in the brain. These accumulated proteins damage nerve cells, eventually leading to their death. Microglia, the brain’s resident immune cells, as well as inflammation, also are thought to contribute to Alzheimer’s neurodegeneration.
Advantage says AD04 may suppress immune, inflammatory responses
Advantage believes that AD04 — an immunomodulator used in human and animal vaccination programs to increase vaccines efficacy — may suppress the immune and inflammatory responses that drive Alzheimer’s.
In preclinical mouse studies, AD04 treatment resulted in fewer inflammatory microglia in the hippocampus, a brain region affected by Alzheimer’s that is important for learning and memory, and improved cognitive function.
In a prior trial using AD04 as a control molecule against therapeutic candidates in early Alzheimer’s patients, 2 mg of the therapy were found to safely and significantly slow the decline in cognitive function, quality of life, and hippocampal volume — a marker of disease progression.
AD04 was recently awarded an innovation passport, the first step in the U.K.’s Innovative Licensing and Access Pathway aimed at accelerating the development and approval of new therapies for conditions of unmet medical need.
In the ongoing Phase 2b trial, participants are randomly assigned to receive either AD04 or a placebo for one year.
The study’s main goal is to evaluate changes in cognitive function using a composite score that integrates three measures: the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale, and the Clinical Dementia Rating-Sum of Boxes.
Changes in these individual cognitive measures, as well as in the Neuropsychiatric Inventory questionnaire, which evaluates dementia-related behaviors, the hippocampal volume, and life quality also will be assessed.
“It is gratifying to achieve this milestone after months of labor by a most dedicated team of professionals,” said Jeffrey Madden, Advantage’s CEO. “We intend to create medicines that will help to prolong lives but also improve their quality. We look forward to providing additional updates on the progress of this potentially landmark trial.”
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