Australian biotechnology company Actinogen Medical has treated the first subject in the XanaMIA Phase IIb clinical trial of Xanamem in biomarker-positive mild to moderate Alzheimer’s disease (AD) patients.
The placebo-controlled, double-blind trial will enrol 220 participants with mild-to-moderate AD and increased plasma pTau levels.
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It aims to assess Xanamem’s safety and potential to maintain cognition and function over 36 weeks of 10mg daily dosing compared with placebo.
A cognitive test battery involving seven digital assessments is the trial’s primary endpoint.
One of the trial’s secondary endpoints is Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), a validated combined cognitive and functional measure.
In a prior analysis of biomarker-positive mild AD patients who received Xanamem treatment, significant benefits were observed in cognition and the CDR-SB endpoint.
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By GlobalDataThe trial will also explore other secondary endpoints such as the Amsterdam Activity of Daily Living scale, which assesses the participants’ ability to perform everyday tasks.
It is currently underway at 13 Australian sites and is set to expand to the US.
Actinogen CEO Dr Steven Gourlay said: “We are very pleased to announce the first patient treated in our phase IIb trial in patients with 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.
“This phase IIb trial is designed to confirm that Xanamem is a safe and effective new treatment for Alzheimer’s disease and represents a major opportunity for patients and the company.”
Actinogen plans to carry out an interim analysis of the trial next year, after nearly 100 subjects have completed 24 weeks of treatment.
The final results from the trial are due to be released in the first half of 2026.
