Actinogen’s Xanamem®: A Promising Leap in Alzheimer’s and Depression Treatment
- Noel Ong
- May 16
- 5 min read
Actinogen Medical Limited (ASX: ACW) is advancing one of the most promising neuroscience drug candidates in the global biotech pipeline. With its novel oral drug Xanamem® (emestedastat), the company is targeting two of the largest and most urgent unmet needs in modern medicine: Alzheimer’s disease (AD) and Major Depressive Disorder (MDD). The company’s unique approach of controlling brain cortisol levels offers a fresh mechanism of action that stands out in the crowded field of central nervous system (CNS) therapeutics.
Why Cortisol? Why Now?
Figure 1: Xanamem is a small molecule tissue cortisol synthesis inhibitor (11β-HSD1 enzyme) (Source: ACW Corporate Presentation February 2025)
Excess cortisol in the brain is increasingly recognised as a key driver of neurodegeneration and depression. Oral Xanamem® selectively inhibits the enzyme 11β-HSD1, reducing tissue cortisol synthesis in the brain without impacting adrenal cortisol production. This makes it the first and only brain-penetrant cortisol controller in clinical development—a significant competitive edge.
Over 400 patients treated with strong safety results
Low drug interaction risk—ideal for combination therapy
First-in-class oral drug designation with WHO-assigned INN: emestedastat
Alzheimer’s Disease: Early Signals of Disease Modification
Alzheimer’s remains one of the most difficult neurological diseases to treat, with current therapies offering only modest benefits. In contrast, Actinogen’s Phase 2a trial showed that Xanamem slowed disease progression in biomarker-positive AD patients, measured by changes in the gold-standard CDR-SB scale.
pTau181-positive patients experienced clinically meaningful slowing of decline
Interim data from the larger Phase 2b/3 XanaMIA trial is expected in Q4 2025, with final results in H2 2026
This trial includes 220 patients across Australia and the US and aims to build a regulatory pathway with the FDA and EMA already engaged.
Depression: A Safe, Oral Option with New Potential
The Phase 2a XanaCIDD trial in moderate MDD delivered clinically and statistically significant results on key endpoints:
MADRS (depression severity) scores showed improvement from Week 6
Patients on Xanamem had better outcomes when combined with SSRIs
Low side effect burden—no evidence of suicide risk or withdrawal syndrome
With over 365 million antidepressant prescriptions written annually, the demand for well-tolerated alternatives with novel mechanisms is massive. Actinogen’s once-daily, brain-penetrant Xanamem could fill this gap.
Backed by Science, Protected by Patents
Core composition-of-matter patent protection through 2031 (extendable to 2036)
5–10 years of data exclusivity depending on the jurisdiction
Patents covering manufacturing, use in depression and prevention in cognitively normal individuals
Corporate Highlights
Actinogen (ASX: ACW) is a well-funded biotech company with a market cap of approximately $100 million and $22.9 million in cash as of December 2024, providing runway into mid-2026. Key shareholders include Biotech Value Fund (~7%) and CEO Dr. Steven Gourlay (~5%), reflecting strong internal and institutional confidence.
The company is led by a highly experienced board and executive team with deep expertise in biotech, pharma, and central nervous system disorders. including:
Dr. Steven Gourlay – CEO & MD, ex-Roche/Genentech
Dr. Dana Hilt – CMO, veteran neurologist & CNS trial expert
Andy Udell – CCO, commercial strategist with US/EU pharma experience
Dr. Geoff Brooke – Chairman, biotech investor & founder
Upcoming Milestones to Watch
✅ FDA Type C meeting (MDD) – Q1 2025
✅ First patient in US Alzheimer’s trial – Q4 2024
✅ 100th patient enrolled (XanaMIA) – Q2 2025
✅ Peer-reviewed publications – throughout 2025
🔜 Interim Alzheimer’s trial data – Q4 2025
🔜 Final Alzheimer’s and MDD Phase 2 trial results – H2 2026
The Takeaway for Investors
Actinogen is entering a critical window of value creation. With positive Phase 2a data in both AD and MDD, strong patent protection, a unique mechanism, and no direct competitors, Xanamem may represent a transformative asset in CNS therapeutics. Upcoming data readouts and regulatory interactions could serve as major catalysts for the company (Figure 2).
Figure 2: Strong cortisol control scientific rationale to address huge unmet medical need. (Source: ACW Corporate Presentation February 2025)
As the global burden of Alzheimer’s and depression grows, Actinogen’s science-driven approach could deliver not just returns, but real change.
Executive Perspective
Dr. Steven Gourlay, CEO of Actinogen, commented:
“The first quarter of 2025 was a busy period for the team as the XanaMIA trial accelerated and many essential initiatives commenced in parallel with the trial, designed to prepare the Company for partnering and eventual marketing approvals. I was particularly pleased with the positive and clear outcomes from our Type C meeting with the FDA on MDD that provided excellent guidance for the Xanamem program.”
Concluding Comments From Samso
Actinogen Medical is emerging as a key player in neuroscience with its novel drug Xanamem®, targeting Alzheimer’s and depression by safely reducing brain cortisol. Backed by promising clinical results, strong patent protection, and an experienced leadership team, the company is entering a critical phase with upcoming trial milestones.
Samso sees Actinogen as a well-positioned biotech with real potential to deliver both investor value and transformative patient outcomes. The current market capitalisation of AUD $86M would make this more than a punt but one needs to fully understand the potential pathway ahead.
It goes without saying that a potential medial solution to Alzheimer’s disease and Major Depressive Disorder would propel the company's valuation. This is the most obvious decision making process. The fundamental parts of funding, having significant shareholder credibility, proven patents and a clear pathway to FDA approval with final trials is something that is very promising.
This is the kind of story we love to follow. One that merges solid science, smart strategy, and a path to real-world solutions.
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