Phase 2b/3 Alzheimer's trial enrolment passes 50% - twenty US trial sites continuing to recruit participants

SYDNEY , Aug. 27, 2025 /PRNewswire/ -- 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.

Who can join?

• Individuals aged 50 or older with a diagnosis of mild to moderate Alzheimer's disease
• Participants with a study partner willing to attend clinic visits
• Additional eligibility criteria apply

You can find out more information in these ways:

• Check eligibility: https://app.clinials.io/en-US/alzheimers
• Email Actinogen's clinical trials team: clinicaltrials@actinogen.com.au
• Trial website link: https://actinogen.com.au/xanamia-phase-2b-trial/

About Actinogen Medical

Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem® (emestedastat), its novel oral therapy for Alzheimer's disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem, has been studied in eight clinical trials with more than 400 people treated to date and has a promising safety and efficacy profile. ACW's ongoing clinical trial, XanaMIA, is a phase 2b/3 trial of 220 participants with mild to moderate Alzheimer's disease (AD) and is currently enrolling in Australia and the US. To find out more about the trial click here.

About Xanamem (emestedastat)

Xanamem's novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer's Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer's disease and improve depressive symptoms in patients with moderately severe depression. To view Xanamem's two-minute Mechanism of Action video, click here.

Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical.

List of XanaMIA phase 2b/3 trial clinical sites in the US

To check eligibility: https://app.clinials.io/en-US/alzheimers

Disclaimer

This announcement and attachments may contain certain "forward-looking statements" that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered "at-risk statements" - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realized.

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SOURCE Actinogen Medical Limited