Actinogen Medical Limited said the last participant in its XanaMIA phase 2b/3 trial completed a final visit on September 22 in the United States, and topline results remain on track for release in November, according to a statement filed with the Australian Securities Exchange on September 23. The trial tests Xanamem (emestedastat), an oral capsule designed to inhibit an enzyme that raises cortisol levels inside brain cells, a mechanism distinct from the amyloid-clearing or tau-clearing antibodies now approved or in late-stage testing for Alzheimer's disease.
XanaMIA is a randomized, double-blind, placebo-controlled study of 247 people with mild to moderate Alzheimer's disease who were selected for elevated blood pTau181, a biomarker associated with faster disease progression. Participants received 10 milligrams of Xanamem or placebo daily for 36 weeks, recruited across Australia and the United States. The company describes this as the first Xanamem trial to run longer than 12 weeks.
The biomarker-selection strategy traces back to an earlier phase 2 trial, XanADu, which did not meet its primary or secondary endpoints in the overall study population. A subsequent post-hoc analysis of that trial's blood samples, published in the Journal of Alzheimer's Disease in 2024, reported that participants with elevated pTau181 showed signs of faster decline and, in an exploratory comparison, some potential drug-associated slowing. That earlier finding was not a confirmatory result and is the rationale for enrolling only pTau181-elevated patients in XanaMIA.
What was disclosed this week is procedural: a trial milestone reported by the drug's own sponsor, not a result. No efficacy or safety data from XanaMIA have been released, and the statement is a company disclosure to shareholders rather than a peer-reviewed report.