Actinogen Clears Final Trial Hurdle Ahead of Alzheimer’s Data
Actinogen Medical has completed the final patient visit in its 247-participant XanaMIA Alzheimer’s disease trial, keeping topline results on track for November 2026. The milestone closes patient participation in the pivotal study, but provides no indication yet of whether Xanamem improved outcomes.
- Final patient visit completed in the 247-participant XanaMIA trial
- Topline results remain scheduled for November 2026
- 36-week placebo-controlled study tests Xanamem 10 mg
- Primary endpoint is the CDR-SB dementia scale
- Trial uses elevated blood pTau181 to select participants
The waiting game has entered its final stretch. Actinogen Medical (ASX:ACW) has completed the last patient visit in its 247-participant XanaMIA Phase 2b/3 Alzheimer’s disease trial, keeping the company’s planned topline readout on track for November 2026.
XanaMIA Completes Patient Participation
XanaMIA is a randomised, double-blind, placebo-controlled study comparing once-daily Xanamem 10 mg with placebo over 36 weeks. Participants were recruited across Australia and the United States, with 45% enrolled in Australia and 55% in the US.
The primary endpoint is the internationally recognised Clinical Dementia Rating Scale Sum of Boxes, or CDR-SB, alongside a range of other measures. The trial has already passed an independent Data Monitoring Committee review covering safety and efficacy futility, but today’s announcement does not disclose efficacy, safety or statistical results.
Biomarker Selection Shapes the Readout
A defining feature of XanaMIA is its use of elevated blood pTau181 to select participants with biomarker-confirmed Alzheimer’s disease and a more progressive disease course. Actinogen says the approach is intended to improve the trial’s ability to detect a treatment effect over 36 weeks, while avoiding the more complex use of amyloid brain scans or cerebrospinal fluid biomarkers.
The enrolled group had an average age of 75, included 49% women and 66% ApoE4 carriers, and recorded mean pTau181 of 2.6 pg/mL and mean CDR-SB of 4.3 points. Those figures describe the trial cohort; they are not treatment results.
November Data Will Test Xanamem’s Thesis
Xanamem is an investigational oral inhibitor of the 11β-HSD1 enzyme, designed to reduce cortisol levels inside the brain without suppressing adrenal cortisol production. Actinogen is positioning the drug as a potential treatment for Alzheimer’s disease, but it is not approved by the FDA or any other global regulatory authority.
The next material event is therefore the November topline release, where the CDR-SB result, safety profile and statistical analysis will determine whether the trial supports further regulatory development. The separate XanaMIA open-label extension allows participants to receive Xanamem 10 mg for up to 25 months, offering a potential source of longer-term follow-up, but it cannot substitute for the controlled comparison at the centre of the pivotal readout.
Bottom Line?
The operational milestone is complete; the investment case now turns almost entirely on whether November’s controlled data show a meaningful and statistically credible effect on CDR-SB.
Questions in the middle?
- Will Xanamem produce a statistically significant improvement in the primary CDR-SB endpoint versus placebo?
- What safety findings and subgroup results will accompany the November topline data?
- If the result is positive, how quickly can Actinogen translate it into a regulatory pathway for an unapproved therapy?
