Actinogen Medical has fast-tracked recruitment in its XanaMIA Alzheimer’s trial, closing pTau biomarker screening early and increasing participant numbers, aiming for final results by mid Q4 2026.
- pTau biomarker screening closes October 31, one month ahead of schedule
- Total enrolment target increased to approximately 240 participants
- Currently 180 participants enrolled, with 60 more expected by year-end
- Final topline results projected for mid Q4 2026
- Interim safety and efficacy analysis planned for January 2026
Accelerated Recruitment Boosts Trial Momentum
Actinogen Medical (ASX, ACW) has announced a significant acceleration in the recruitment phase of its pivotal XanaMIA Phase 2b/3 trial targeting Alzheimer’s disease. The company will close pTau biomarker screening a full month earlier than planned, on October 31, 2025, reflecting robust enrolment and strong interest from participants and clinical sites.
Originally aiming for 220 participants, Actinogen has increased its target to approximately 240, with 180 already enrolled and an additional 60 expected by the end of the year. This expanded cohort is expected to enhance the statistical power of the trial, potentially strengthening the reliability of the results.
Xanamem’s Novel Approach to Alzheimer’s
The XanaMIA trial evaluates Xanamem, an oral therapy designed to modulate elevated brain cortisol levels, a hormone linked to cognitive decline and neuronal damage in Alzheimer’s disease. Unlike existing treatments, Xanamem targets the enzyme 11β-HSD1 to reduce cortisol synthesis within the brain without disrupting systemic cortisol production, aiming to slow disease progression.
The trial’s primary endpoint is the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB), an internationally recognized measure of cognitive and functional performance. The study is conducted across Australia and the United States, with a 36-week treatment period comparing Xanamem 10 mg daily against placebo.
Regulatory and Market Implications
Actinogen’s CEO, Dr Steven Gourlay, highlighted the accelerated enrolment as a positive signal of Xanamem’s market potential, especially given its oral administration and novel mechanism compared to existing anti-amyloid antibody infusions. The trial’s design aligns with recent FDA agreements, positioning XanaMIA as one of two pivotal studies underpinning future regulatory submissions.
An independent Data Monitoring Committee will conduct a formal interim analysis of safety and efficacy futility in late January 2026, providing an early read on the drug’s performance. Final topline results are anticipated by mid Q4 2026, marking a critical milestone for Actinogen and its investors.
Looking Ahead
Beyond XanaMIA, Actinogen is preparing an open-label extension study (XanaMIA-OLE) to further evaluate long-term safety and efficacy, as well as exploring Xanamem’s potential in depression and other neurological conditions. The company’s focus on cortisol modulation represents a promising frontier in neurodegenerative disease treatment, addressing a substantial unmet medical need.
Bottom Line?
With accelerated enrolment and expanded participant numbers, Actinogen is poised to deliver pivotal data that could reshape Alzheimer’s treatment paradigms by late 2026.
Questions in the middle?
- Will the interim analysis in January 2026 confirm early signs of efficacy and safety?
- How will the increased enrolment impact the statistical significance and regulatory confidence in the trial outcomes?
- What are the competitive implications for Xanamem against existing and emerging Alzheimer’s therapies?