Actinogen Medical Advances in Alzheimer’s Research with US Trial Launch

In a significant step toward combating Alzheimer’s disease, Actinogen Medical Limited has announced the successful randomization and treatment of its first participant in the XanaMIA phase 2b/3 clinical trial in the United States. This milestone marks the beginning of an essential effort to explore new therapies aimed at patients with mild to moderate Alzheimer's disease.

The trial commenced in the US on December 9, 2024, and aims to enroll 220 participants who display biomarker-positive characteristics indicative of the disease, specifically through elevated levels of the blood biomarker pTau181.

A Comprehensive Study

The XanaMIA trial is meticulously designed to administer a daily dosage of Xanamem® at 10 mg over a 36-week period. Researchers are keenly focused on a diverse range of clinical endpoints that assess both cognitive function and daily living performance among participants. A pivotal aspect of the trial’s evaluation involves the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), which comprehensively assesses a patient’s cognitive and functional status. This validated measure is recognized by the FDA and is frequently employed by various companies as an essential endpoint for regulatory approval.

Earlier analyses of patients with mild Alzheimer’s who received Xanamem revealed promising results, indicating a statistically significant benefit over placebo after 12 weeks of treatment, reflected in an improvement of 0.6 points on the CDR-SB scale.

The trial will also take into account several secondary endpoints, such as the Amsterdam Activity of Daily Living scale, which gauges the ability to perform everyday tasks, alongside a suite of cognitive assessments designed to provide a thorough evaluation of participants' mental functions.

Trial Execution and Timeline

With the initiation of ten clinical sites in the United States, in addition to the existing fifteen sites in Australia, Actinogen anticipates a swift recruitment process and the early screening of potential trial participants. An interim analysis is scheduled for the third quarter of 2025 when around 100 patients are expected to complete 24 weeks of treatment. The final results of this ambitious trial are projected to be released in the latter half of 2026.

Dr. Steven Gourlay, CEO and Managing Director of Actinogen, expressed enthusiasm about the progress: “We are thrilled to announce the first participant treated in the US as part of our comprehensive phase 2b/3 trial in Alzheimer’s. The expansion into the US with ten new sites significantly enhances our recruitment efforts already underway in Australia.”

Leadership Expansion

In a strategic move to strengthen its operational capabilities, Actinogen has appointed Andrew (Andy) Udell as Chief Commercial Officer. Based in the United States, Udell brings extensive experience in guiding biotech companies from clinical phases to market readiness, which is crucial as Actinogen gears up for the commercial landscape surrounding Alzheimer's treatment. His past successes include steering Calliditas Therapeutics through critical phases of trial and market launch in North America.

Media Attention and Community Response

The innovative mechanism of Xanamem, which regulates cortisol levels in the brain, has attracted considerable media attention in Australia and beyond. The exciting potential of this compound to safely and effectively treat Alzheimer’s disease has piqued public interest, resulting in an influx of inquiries from potential trial volunteers eager to participate in the crucial study.

As Dr. Gourlay noted, “It’s incredibly rewarding to see a surge in media interest around Xanamem’s unique properties, positioning it as a distinguished approach among existing therapies for Alzheimer’s.” With an ageing population and increasing life expectancy in Australia, the urgency for innovative therapeutic solutions has never been higher. The rise of dementia as a leading cause of mortality reinforces the importance of Actinogen's efforts.

About Actinogen Medical

Actinogen Medical (ASX: ACW) stands at the forefront of biotechnology, developing cutting-edge therapies for neurological and neuropsychiatric conditions linked to cortisol dysregulation. They are focused on the needs of patients with cognitive impairments, behavioral challenges, and other debilitating conditions. Xanamem, their lead compound, targets the underlying biological pathways linked to Alzheimer’s and depression, with the goal of improving patients' quality of life and cognitive functioning.

This phase 2b/3 trial represents hope not just for Actinogen, but for the millions affected by Alzheimer's, as it offers the potential for breakthroughs that could reshape the future of dementia treatment.