Actinogen Medical launches Alzheimer’s trial to test impact of Xanamem on cognitive health
Actinogen Medical (ASX: ACW) has treated the first subject in its clinical trial of patients with biomarker-positive mild to moderate Alzheimer’s disease.
The XanaMIA Phase 2b trial involves 220 participants with elevated levels of the blood biomarker pTau and measures the effects of a Xanamem 10mg daily dose versus placebo over a 36-week treatment period.
Actinogen’s chief executive officer and managing director Dr Steven Gourlay said the trial is being conducted at 13 Australian sites before subsequently expanding to the USA.
The Phase 2b trial is designed to further confirm that Xanamem is a safe and effective new treatment for Alzheimer’s disease.
“Based on encouraging safety and clinical activity seen in multiple prior trials of Xanamem and a strong scientific rationale for reducing brain cortisol levels, we are confident that the trial will confirm clinically and statistically meaningful results,” Dr Gourlay said.
“The clear priority for the next 18 months is to deliver high-quality results from our ongoing Phase 2 clinical trials in depression and Alzheimer’s disease, the first of which will report results in Q3 this year.”
Major impact
Alzheimer’s disease causes the brain to shrink and brain cells to eventually die. It is the most common cause of dementia—a gradual decline in memory, thinking, behaviour and social skills.
According to Health Direct, nearly 70% of people with dementia have Alzheimer’s disease.
Alzheimer’s disease affects up to one in ten Australians over 65 years of age.
This figure increases to three in ten over 85 years.
Benefits identified
The benefits of Xanamem on cognition were observed in three earlier placebo-controlled trials including an initial study.
The primary endpoint for the new Alzheimer’s trial is a cognitive test battery comprising seven different digital assessments.
The trial’s secondary endpoint will be the assessment of clinical dementia rating—sum of boxes scale (CDR-SB), the validated combined cognitive and functional measure.
FDA-approved test
The CDR-SB test is used by the Food and Drug Administration (FDA) and many companies as a primary or secondary endpoint for regulatory approval.
An analysis of biomarker-positive patients with mild Alzheimer’s disease treated with Xanamem previously identified clinically significant benefits on cognition and the CDR-SB endpoint.
An interim analysis is planned for mid-2025 when approximately 100 patients reach 24 weeks of treatment, with final results anticipated in H1 CY26.