Actinogen Medical Limited (ASX: ACW) announces that a recent trial designed to confirm therapeutic blood levels of the intended commercial tablet formulation of Xanamem®, given both with and without food, demonstrated the expected blood levels or "exposure", comparable with prior studies of a capsule formulation. This indicates that 10 mg once daily remains the target therapeutic dose for the clinical program.

The trial was conducted at the CMAX clinical research center in Adelaide, Australia where 16 individuals were studied on two occasions, one week apart. Each received a 10 mg tablet of Xanamem once while fasting and once after a high fat meal. Blood levels of Xanamem were then measured frequently over the ensuing 48 hours.

Key results include the median time to maximum blood concentration of 4 to 6 hours (4 hours fasted, 6 hours after a high fat meal), and very similar Xanamem exposures (area under the concentration-time curve) and elimination half-life of 15 hours in both fed and fasted situations.

Professor Paul Rolan, Actinogen's Clinical Pharmacologist commented:

"This trial confirmed that the intended commercial formulation of Xanamem produces consistent and therapeutic levels in the blood that are similar when given with or without food, giving full flexibility for dosing. These data support the use of the 10 mg daily dose irrespective of food intake in the ongoing XanaMIA phase 2b/3 trial in people with mild to moderate Alzheimer's disease. Xanamem is a remarkable oral therapeutic with low drug interaction potential, and a 15-hour half-life suitable for once daily dosing in an elderly population."

XanaMIA phase 2b/3 Alzheimer's disease trial progress

Enrolment in the pivotal XanaMIA phase 2b/3 Alzheimer's disease (AD) clinical trial has passed 55% as at the end of July 2025.

The trial is enrolling 220 participants with elevated levels of the blood biomarker pTau181, designed to identify participants with biomarker-positive AD whose disease is likely to progress during the 36-week treatment period of the trial, and therefore augment the ability to detect a Xanamem (emestedastat) treatment benefit. The primary endpoint of the trial is the Clinical Dementia Rating – Sum of Boxes scale, universally included in contemporary AD trials. Other measures include the effects of Xanamem on clinical endpoints of cognition and functional ability.

A planned safety and efficacy futility interim analysis of all available data by an independent Data Monitoring Committee will occur in January 2026.

Final results for the full enrolment of 220 participants are expected in Q4 2026.

How to enrol in the XanaMIA phase 2b/3 Alzheimer's disease trial in the US

Actinogen is encouraging individuals and their loved ones affected by Alzheimer's disease to take part in a groundbreaking clinical trial that could transform the way we treat this devastating condition.

The trial is enrolling people diagnosed with mild to moderate Alzheimer's disease, offering them a chance to participate in cutting-edge research aimed at stabilizing the cognitive and functional decline of Alzheimer's.

Xanamem inhibits the production of the "stress hormone", cortisol, in key areas of the brain that are linked to memory and critical thinking. Watch a two-minute explainer video on how Xanamem works here.

The trial involves taking a single pill once a day of Xanamem or matching placebo ("sugar pill") and a series of clinic visits for the assessment of Alzheimer's progress. It does not involve frequent brain scans or complicated procedures such as lumbar puncture.

All participants at the end of the XanaMIA trial are eligible for Actinogen's open-label extension trial of active Xanamem for up to 24 months. This extension trial will open to completed XanaMIA participants in early 2026.