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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.