Actinogen Medical has finalized enrollment and begun treatment of all 246 participants in its XanaMIA Phase 2b/3 Alzheimer’s trial, with topline results expected in November 2026. The oral drug Xanamem targets brain cortisol to potentially slow disease progression.
- Full enrollment of 246 participants in XanaMIA Alzheimer’s trial completed
- Topline final results scheduled for November 2026
- Interim safety and futility analysis by independent committee due January 2026
- Open-label extension phase to start in Q1 2026 offering active treatment to all participants
- Xanamem targets elevated brain cortisol, a novel approach in Alzheimer’s therapy
Full Enrollment Marks Milestone in XanaMIA Trial
Actinogen Medical Limited (ASX, ACW) has announced the completion of enrollment and commencement of treatment for all 246 participants in its pivotal XanaMIA Phase 2b/3 clinical trial for Alzheimer’s disease. This exceeds the original target of 220 participants, providing the trial with enhanced statistical power to assess the efficacy and safety of Xanamem, an oral once-daily drug designed to modulate elevated brain cortisol levels.
The XanaMIA trial is a randomized, double-blind, placebo-controlled study conducted across sites in Australia and the United States. It evaluates Xanamem’s ability to slow cognitive decline over 36 weeks in patients with mild to moderate Alzheimer’s disease, confirmed by elevated pTau181 biomarker levels. The primary endpoint is the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB), a widely accepted measure of cognitive and functional impairment.
Interim Analysis and Open-Label Extension
An independent Data Monitoring Committee (DMC) will conduct a confidential interim analysis in late January 2026 to assess safety and futility based on all available data. This review will determine whether the trial should continue as planned. Following the double-blind phase, an open-label extension will commence in the first quarter of 2026, allowing all participants, including those previously on placebo, to receive active Xanamem treatment for up to 25 months. This phase aims to gather longer-term safety and efficacy data.
Xanamem’s Novel Mechanism and Clinical Promise
Xanamem operates by inhibiting the enzyme 11β-HSD1, thereby reducing elevated cortisol levels in key brain regions implicated in Alzheimer’s pathology. Elevated brain cortisol is associated with accelerated cognitive decline and neuronal damage. Prior phase 2 trials have demonstrated encouraging signals, including a significant slowing of cognitive deterioration in biomarker-positive patients and improvements in depressive symptoms, which often co-occur with Alzheimer’s disease.
Actinogen’s CEO Dr Steven Gourlay expressed confidence in the trial’s progress and timeline, highlighting the drug’s safety profile and ease of administration as potential differentiators in a crowded Alzheimer’s treatment landscape. The company is actively engaging with regulatory authorities, including the FDA and European Medicines Agency, to streamline the path toward approval.
Commercial and Regulatory Outlook
With the Alzheimer’s market expanding rapidly, particularly in the United States, Xanamem’s oral administration and novel mechanism could offer a compelling alternative to existing therapies, many of which require intravenous administration and carry significant side effects. Actinogen is also pursuing partnerships and preparing for a pivotal Phase 3 trial, contingent on positive XanaMIA outcomes.
The company’s strategic approach includes leveraging robust biomarker-driven patient selection and comprehensive cognitive and functional assessments to maximize the trial’s potential to demonstrate meaningful clinical benefit.
Bottom Line?
As Actinogen advances toward critical interim and final readouts, the Alzheimer’s community and investors await confirmation of Xanamem’s potential to reshape treatment paradigms.
Questions in the middle?
- Will the January 2026 interim analysis affirm the trial’s continuation and safety profile?
- How will Xanamem’s efficacy compare to existing Alzheimer’s therapies upon final analysis?
- What regulatory milestones and partnership deals might follow positive XanaMIA results?