Actinogen Medical Limited (ASX: ACW) Highlights Xanamem’s Dual Potential at World’s Leading Dementia Forum – The AAIC 2025.
- Noel Ong
- 7 days ago
- 6 min read
Announcement
Actinogen Medical Limited (ASX: ACW) has added another important milestone in its clinical development journey, showcasing new data that reinforces the mechanism and therapeutic promise of Xanamem® (emestedastat). The company’s Chief Medical Officer, Dr Dana Hilt, and Senior Clinical Scientist, Dr Jack Taylor, are presenting a scientific poster at the prestigious Alzheimer’s Association International Conference (AAIC 2025) in Toronto, the world’s largest platform for dementia research and discussion.
Their poster—Validating the Cortisol Hypothesis: Xanamem Demonstrates Positive Clinical Effects by Lowering CNS Cortisol in MDD—presents data that supports the targeted inhibition of cortisol in the brain as a meaningful intervention for patients with moderately severe major depressive disorder (MDD). The poster summarises statistically and clinically significant benefits from the XanaCIDD Phase 2a trial and reinforces the enzyme target that underpins Xanamem’s development pathway.
Key Highlights & Summary - The Path to A Solution for Dementia.
1. Clinical Data from the XanaCIDD Trial
The trial involved 167 MDD patients with treatment-resistant depression and mild cognitive impairment.
Patients received 10 mg of Xanamem or placebo once daily for 6 weeks in a double-blind design.
The trial demonstrated (Figure 1):
A 2.7-point improvement on the MADRS scale (Cohen’s d = 0.43, p = 0.02) post-treatment.
A 4.16-point improvement in SSRI-concurrent patients (Cohen’s d = 0.64, p = 0.03).
PGI-S improvements were also recorded, confirming patient-reported reductions in symptom severity.
Figure 1: Xanamem displaying clinically significant improvements in depression. (source: Actinogen)
A higher proportion of patients receiving Xanamem achieved ≥50% reductions in Montgomery-Asberg Depression Rating Scale (MADRS) scores and reached symptom remission compared to placebo (Figure 2).
Figure 2: Patients treated with Xanamem showed higher rates of both clinically meaningful improvement (≥50% reduction in MADRS scores) and remission (MADRS scores <10) compared to placebo, indicating a stronger overall therapeutic response in depressive symptoms.
Importantly, Xanamem was well tolerated with a safety profile comparable to placebo. No serious drug-related adverse events were reported.
2. Xanamem's Mechanism and Broader Implications
Xanamem is a first-in-class, once-daily oral inhibitor of the 11β-HSD1 enzyme, designed to lower brain cortisol without affecting systemic production.
Cortisol is strongly implicated in neurodegenerative and mood disorders, with chronic elevation known to damage neurons and impair cognition.
The XanaCIDD trial validates that reducing cortisol via Xanamem improves depressive symptoms, affirming the role of this pathway in both MDD and Alzheimer’s disease.
3. Phase 2b/3 Alzheimer’s Disease Trial – XanaMIA
A major late-stage program currently underway, testing Xanamem in 220 patients with mild to moderate Alzheimer’s disease.
The primary endpoint is the CDR-SB score, with interim data expected in January 2026 and final results in Q4 2026.
A 24-month open-label extension (XanaMIA-DUR) is also planned, set to commence in early 2026.
Dr Dana Hilt, Chief Medical Officer at Actinogen, commented:
“The positive results from the XanaCIDD depression trial of Xanamem validate Xanamem’s mechanism of action and 10 mg daily dose. We are confident that the current Phase 2b/3 XanaMIA trial can generate the confirmatory data needed to support future global regulatory approvals.”
With the cortisol hypothesis increasingly gaining attention in neuropsychiatric research, Xanamem’s dual-pathway targeting of both mood and memory-related disorders presents a compelling development strategy.
Samso Concluding Comments
From a Samso perspective, this update is a promising continuation of what the company is trying to achieve as the ultimate prize for the business. Actinogen has long signalled its belief in cortisol’s pivotal role in brain health, and the data from the XanaCIDD trial brings critical clinical validation to that theory.
The ability to show both mechanistic and symptomatic improvements, particularly in a condition as complex as major depressive disorder, speaks volumes about the potential crossover efficacy for Alzheimer’s disease. While drug development remains an inherently risky endeavour, especially in neurology, this kind of peer-reviewed, data-driven progress offers reassurance to long-term investors watching the Actinogen story unfold.
As the company moves towards key readouts in 2026 for Alzheimer’s disease, this MDD data gives the market a valuable glimpse into Xanamem’s broader utility. For investors, it’s a signal that Actinogen is aligning solid clinical science with commercial ambition—and that’s a formula worth paying attention to.
Figure 3: The actinogen share price chart as of 11th May 2025. (source: commsec).
Actinogen is one of the many health related companies that seem to be close to the holy grail of discovery/ A discovery of success with what Actinogen is trying to do will be a game changer for the company as anything that alleviates patients with Dementia symptoms would be lucrative. With a current market capitalisation of AUD $79.42M. It does seem expensive for a punt, but if the path is near the end of the race, this may turn out to be a cheap punt.
What I have learnt over the years in the mineral exploration industry and what I am quickly learning from the biotech sector is that the path to glory is a positive log scale with the biotech sector. The mineral exploration sector kind of goes the other way. As you get closer to realising the discovery is moving from a resource to a reserve, the interest in the stock diminishes. The excitement goes away, and the slow decline in share prices begins until production happens.
Hence, the higher market capitalisation for the company may actually be a truer indication that confidence is in the stock, and the anticipation of a share price value rising may be closer.
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At Samso, we’re always focused on the science behind the story. A company like Actinogen Medical may operate in a space where volatility and sentiment often obscure fundamentals, but here, the evidence speaks for itself. Clinical proof, peer-reviewed validation, and a well-defined regulatory strategy are the cornerstones of compelling biotech narratives. Xanamem is delivering those pillars, step by step.
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