Alzheimer’s Trial Milestone Sets Stage for Critical Safety and Efficacy Review
Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.
- 100+ participants enrolled in XanaMIA Alzheimer’s trial
- Interim safety and efficacy futility analysis scheduled for January 2026
- Final trial results expected in Q4 2026 with 220 participants
- FDA meeting planned in H2 2025 to discuss regulatory pathways
- Open-label extension trial to start in Q1 2026
Milestone Enrollment in Alzheimer’s Trial
Actinogen Medical has announced a significant milestone in its development of Xanamem, a novel oral therapy targeting Alzheimer’s disease. The company has enrolled its 100th participant in the pivotal XanaMIA phase 2b/3 trial, a key step that triggers the timeline for an interim analysis by an independent Data Monitoring Committee (DMC). This milestone confirms the trial is progressing on schedule, with the 24-week treatment visit for these participants expected in late December 2025.
Interim Analysis and Safety Oversight
The DMC, composed of independent clinical and statistical experts, will conduct a confidential review of unblinded safety and efficacy data in January 2026. This interim analysis is designed as a futility check, meaning the trial will only be stopped early if the data suggest the treatment is unlikely to demonstrate benefit or if there are major safety concerns. Importantly, the committee will not recommend stopping the trial early for success, underscoring Actinogen’s commitment to robust data collection through full enrollment of 220 participants.
Regulatory Engagement and Future Plans
Looking ahead, Actinogen plans to meet with the US Food and Drug Administration (FDA) in the second half of 2025 to discuss potential regulatory approval pathways for Xanamem. The company is exploring both conventional and expedited routes, depending on the strength of the trial’s efficacy and safety data. An open-label extension trial, where all participants receive active treatment, is set to commence in early 2026, offering additional long-term safety and efficacy insights.
Xanamem’s Unique Mechanism and Market Potential
Xanamem works by inhibiting the 11β-HSD1 enzyme to control cortisol levels in brain regions critical for memory and cognition. Elevated cortisol is linked to the progression of Alzheimer’s and cognitive decline, making this a novel therapeutic target. The drug’s once-daily oral dosing and low potential for drug interactions position it as a convenient option that could be used alone or alongside existing treatments.
Looking to 2026 and Beyond
Final results from the XanaMIA trial are anticipated in the fourth quarter of 2026, with a second pivotal phase 3 trial planned to start in early 2027. Actinogen’s CEO, Dr Steven Gourlay, expressed confidence in the trial’s progress and the potential of Xanamem to become a meaningful addition to Alzheimer’s treatment options. The company’s strategic approach, combining rigorous clinical evaluation with proactive regulatory engagement, will be closely watched by investors and the broader biotech community.
Bottom Line?
The January 2026 interim review will be a crucial checkpoint for Xanamem’s future, setting the tone for regulatory discussions and the next phase of development.
Questions in the middle?
- Will the interim analysis reveal any early signs of efficacy or safety concerns?
- How might FDA feedback influence Actinogen’s regulatory strategy and timelines?
- What partnerships or collaborations could accelerate Xanamem’s commercialisation?