#Australia #Sydney #Alzheimer's #Xanamem #Actinogen

Actinogen's Recent Trial of Xanamem for Alzheimer's Disease

Actinogen Medical Limited has announced exciting results from a trial aimed at evaluating their therapeutic drug, Xanamem, aimed at treating Alzheimer's disease. The significance of this trial lies in its ability to confirm the drug's effective blood levels regardless of whether patients took the medication with food or on an empty stomach. The findings from this trial are pivotal as they reinforce the proposed therapeutic dose of 10 mg daily, a critical component of their ongoing clinical strategy.

Trial Details

Conducted at the CMAX clinical research center in Adelaide, Australia, this trial involved 16 participants who were subjected to two separate evaluations, spaced a week apart. Each participant took a 10 mg tablet of Xanamem once while fasting and once after consuming a high-fat meal. The primary aim was to measure the resultant blood levels of the drug over a 48-hour period. Key findings revealed that the median time to reach the maximum blood concentration was achieved between 4 to 6 hours, demonstrating consistent absorption and effectiveness in both scenarios.

The results showed a similar exposure to the compound in terms of the area under the concentration-time curve and exhibited a 15-hour elimination half-life in both fed and fasted states. These results were explained by Professor Paul Rolan, Actinogen's Clinical Pharmacologist, who emphasized that the new commercial formulation of Xanamem offers flexibility in dosing, ensuring compatible therapeutic levels in the bloodstream.

Implications for Alzheimer's Treatment

The successful confirmation of these blood levels is not just academic; it directly supports the design of the ongoing XanaMIA phase 2b/3 trial focused on individuals with mild to moderate Alzheimer's disease. The trial’s enrollment has surpassed 55% as of late July 2025, with a goal of including 220 participants presenting elevated levels of the blood biomarker pTau181, indicative of likely disease progression. This biomarker-driven approach aims to enhance the trial's ability to measure the benefits of Xanamem in stabilizing cognitive decline and improving overall functional abilities in participants.

The primary endpoint will assess the clinical dementia rating, a standard measure in modern Alzheimer's studies, while secondary measures will evaluate cognitive performance and functional capabilities.

How to Participate

Actinogen is actively recruiting individuals diagnosed with mild to moderate Alzheimer's, encouraging potential participants to engage in this groundbreaking research. Adding to its appeal, the trial design is user-friendly, requiring daily intake of Xanamem or a placebo, alongside periodic clinic evaluations without the complexity of frequent brain scans or invasive procedures like lumbar punctures.

By participating, individuals can access innovative treatment avenues that could alter the landscape of Alzheimer's management. Moreover, they will have a chance to join an open-label extension trial, allowing for up to 24 months of active treatment upon completion of the initial trial.

About Actinogen Medical

Actinogen Medical is a biotechnology firm listed on the ASX (ACW), and it’s at the forefront of developing Xanamem (emestedastat), its promising oral therapeutic for Alzheimer's disease and depression. Hailing from Sydney, Australia, the company has executed more than eight clinical trials involving over 400 participants thus far, which sets a hopeful tone toward both safety and efficacy. The multi-national clinical endeavors, particularly the XanaMIA Phase 2b/3 trial, exemplify the organization's commitment to addressing the pressing challenges faced by those dealing with neurodegenerative conditions.

By keeping the same promising dose regardless of food intake, . This novel approach might significantly enhance flexibility and adherence in the Alzheimer’s patient population, subsequently paving the way for future advancements in treatment protocols.

For more information, interested parties can check eligibility here or reach out through the Actinogen clinical trials team at [email protected]