Actinogen Medical's Xanamem Trial Shows Positive Results
Actinogen Medical's Breakthrough in Alzheimer’s Treatment
Actinogen Medical Limited (ASX: ACW) has announced promising results from a recent trial aimed at validating the efficacy of Xanamem, its innovative tablet formulation intended for treating Alzheimer's disease. This trial confirmed that the therapeutic blood levels of the Xanamem tablet, when administered both with and without food, align with previous findings from earlier studies that utilized capsule forms.
Through the detailed investigation at a well-known clinical research center, researchers monitored 16 individuals over two distinct occasions separated by a week. Each participant received a 10 mg tablet of Xanamem once while fasting and again after consuming a high-fat meal. Blood levels of the medication were meticulously tracked over 48 hours, revealing essential pharmacokinetic data.
The study delivered key insights, showing that participants reached maximum blood concentration levels within 4 to 6 hours, depending on their meal state. Furthermore, it illustrated that the absorption and elimination of Xanamem remained consistent across fed and fasted states, with a notable 15-hour half-life allowing for convenient once-daily dosing.
Insights from Clinical Experts
Professor Paul Rolan, a prominent Clinical Pharmacologist at Actinogen, expressed enthusiasm regarding the trial findings, stating, "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. The data collected supports the continued use of the 10 mg daily dose, allowing ease of adherence for patients with Alzheimer's disease.”
Progress of the XanaMIA Phase 2b/3 Trial
The ongoing XanaMIA phase 2b/3 clinical trial has seen substantial progress, enrolling over 55% of its target of 220 participants diagnosed with mild to moderate Alzheimer's. This critical study aims to recruit individuals with elevated pTau181 blood biomarkers, highlighting those whose Alzheimer's is likely to progress during the 36-week treatment window.
One of the pivotal endpoints of the XanaMIA trial revolves around the Clinical Dementia Rating – Sum of Boxes scale, which is a standard measure in modern Alzheimer's trials. Additional metrics include evaluating the effects of Xanamem on cognition and functionality.
In January 2026, experts from an independent Data Monitoring Committee will conduct a safety and efficacy analysis, assessing the data collected thus far. The final results for the complete enrolment of participants are expected by Q4 2026, creating a ripple of anticipation among stakeholders.
How to Participate in the XanaMIA Trial
Actinogen is actively encouraging eligible individuals affected by Alzheimer's to engage in this transformative clinical trial. People diagnosed with mild to moderate Alzheimer’s have the opportunity to partake in cutting-edge research aimed at stabilizing cognitive and functional decline.
Participants will be required to take a daily pill dose of Xanamem or a matching placebo alongside periodic clinic visits. Importantly, the trial protocol avoids complex procedures like frequent brain scans or lumbar punctures, simplifying the participation process.
Upon completion of the XanaMIA trial, all participants will qualify for an open-label extension trial, allowing access to active Xanamem for an extended period of up to 24 months from early 2026.
Eligibility Criteria
To participate in this pivotal research, individuals must meet the following criteria:
- Aged 50 years or above with a diagnosis of mild to moderate Alzheimer’s disease.
- Have a study partner available to accompany them to clinical visits.
- Adhere to additional eligibility standards outlined by the research team.
About Actinogen Medical
Actinogen Medical is a biotechnology company listed on the ASX as ACW, committed to pioneering innovative therapies in the field of Alzheimer's and depression. With its headquarters in Sydney, the company spearheads numerous clinical trials across Australia and the United States. Xanamem has undergone extensive clinical evaluations, with participation from over 400 patients, showing promising safety and efficacy.
Xanamem's Innovative Mechanism of Action
Xanamem’s unique approach targets cortisol levels in the brain, inhibiting the cortisol synthesis enzyme, which is critical for managing stress hormones linked to memory and cognition. The biopharmaceutical aims to address chronically elevated cortisol levels, which have been associated with Alzheimer’s progression and depressive symptoms. Preclinical trials have shown that Xanamem can significantly mitigate these issues.
Frequently Asked Questions
What is the scope of the XanaMIA trial?
The XanaMIA trial focuses on evaluating the effects of Xanamem on mild to moderate Alzheimer’s disease, assessing both safety and efficacy over a treatment period.
How does Xanamem work?
Xanamem inhibits cortisol production in key brain regions, playing a crucial role in memory function and cognitive performance.
Can anyone join the XanaMIA trial?
Participants must be aged 50 or older with a mild to moderate Alzheimer’s diagnosis and fulfill other eligibility criteria.
What are the benefits of participation?
Participants gain access to a cutting-edge treatment and contribute to vital research aimed at improving Alzheimer’s management.
What happens after the trial?
Upon trial completion, participants may have the opportunity to join an open-label extension trial for access to Xanamem for further evaluation.
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