Key Highlights

  • Actinogen's XanaMIA phase 2b/3 Alzheimer's disease trial reached database lock late on 20 October 2026, with all patient visits complete.
  • Guidance for topline results has been narrowed to mid-November 2026, from the earlier and broader guidance of “November”.
  • The trial enrolled 247 participants, 45% in Australia and 55% in the US, comparing oral Xanamem 10 mg with placebo over 36 weeks.
  • Participants were selected using a blood test for elevated pTau181 rather than amyloid brain scans or cerebrospinal fluid biomarkers.

Actinogen Medical (ASX:ACW) has reached database lock on its XanaMIA phase 2b/3 Alzheimer's disease trial, the point at which trial data is treated as final and closed to further changes. The Sydney company said the lock was formally achieved late on 20 October 2026, and it has narrowed its guidance for topline results to mid-November 2026 from the earlier “November”. The trial has completed all patient visits. It enrolled 247 participants in Australia and the United States and compares the oral drug Xanamem (emestedastat) at 10 mg with placebo over 36 weeks.

What Database Lock Means for the Reporting Timetable

Actinogen defined database lock as the point at which trial data is deemed entirely final, clean and locked to further changes. The final dataset then passes to statistical analysis teams, who process it according to pre-specified analysis plans and produce a set of tables, listings and figures. Those outputs are closely checked in a quality control process before being handed to the company as the “topline final results”.

With the lock complete, the company narrowed its guidance for those results to mid-November, having previously said only “November”. The change narrows the window rather than moving the date, since mid-November falls inside the month the company had already flagged. Chief executive and managing director Dr Steven Gourlay said that positive results in November would establish control of brain cortisol as an important and treatable part of the biology of Alzheimer's disease. He also thanked patients, families, clinical site staff and trial teams, as well as shareholders, for their contributions to the XanaMIA study.

XanaMIA Design: 36 Weeks, 1:1 Randomisation and a Placebo Arm

XanaMIA is a randomised, double-blind, placebo-controlled pivotal trial. Participants were randomised 1:1 to Xanamem 10 mg or placebo, taken once daily, and double-blind means the treatment assignment is masked. The 247 participants have mild to moderate Alzheimer's disease with a progressive course, and 45% were enrolled in Australia and 55% in the US. The trial is closed to recruitment and has passed an independent Data Monitoring Committee safety and efficacy futility review.

The primary endpoint is the CDR-SB, the Clinical Dementia Rating scale – Sum of Boxes, which the company describes as internationally recognised. After the randomised phase, all participants may enrol in an open-label extension called XanaMIA-OLE, in which everyone receives Xanamem 10 mg once daily for up to 25 months. That extension began in March 2026, is open to former and current participants, and evaluates safety and a limited number of efficacy endpoints such as the CDR-SB.

Blood-Test Selection and the Cortisol Mechanism Behind Xanamem

A feature of the design is the use of pTau181, a protein biomarker measured in blood, to confirm Alzheimer's disease in participants. Actinogen said it used a clinically validated blood test instead of more complex methods such as amyloid brain scans or cerebrospinal fluid biomarkers. The company added that elevated pTau181 selects for a more progressive disease course, which increases the trial's statistical power (its ability to detect a real treatment effect) over 36 weeks. It said this also replicates the diagnostic profile of a phase 2a patient population in which a large treatment benefit for Xanamem was seen, citing Taylor et al. 2024.

Xanamem is designed to control elevated cortisol, often called the stress hormone, in the brain by inhibiting 11β-HSD1, an enzyme involved in cortisol synthesis, without affecting cortisol production by the adrenal glands. The company has studied this inhibition in more than 500 volunteers and patients across eight clinical trials, and a human PET imaging study showed high levels of target engagement in the brain at doses as low as 5 mg daily. Xanamem is an investigational product and is not approved for use outside a clinical trial by the FDA or any global regulatory authority.

Taking Stock of the XanaMIA Lock

Actinogen Medical (ASX:ACW) has locked the database for XanaMIA, a 247-participant, 36-week trial of Xanamem 10 mg against placebo, and all patient visits are complete. The lock was formally achieved late on 20 October 2026, and topline final results are now guided for mid-November 2026 rather than the broader November window. Statistical teams will process the locked dataset according to pre-specified plans, and the outputs will pass through quality control before the company receives them. The primary endpoint is the CDR-SB, and participants may continue into XanaMIA-OLE, which began in March 2026 and runs for up to 25 months.