Actinogen

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer’s disease trial and interim analysis timeline

Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that the 100th participant in its pivotal XanaMIA phase 2b/3 randomized trial of Xanamem® for Alzheimer’s disease (AD) has now passed all screening tests and is scheduled for randomization and treatment in July. This establishes the timeline for the planned safety and efficacy futility interim analysis by an independent Data Monitoring Committee (DMC).


Highlights:

  • More than 100 eligible participants are now enrolled in the XanaMIA AD trial, with the 24-week visit “trigger” for interim data analysis based on those participants occurring in late December 2025
  • The DMC review of all available interim data will occur in January 2026 after which the results of the interim analysis will be announced
  • Final trial results for 220 participants are anticipated in Q4 2026.

The DMC comprises independent clinical and statistical experts who are not connected to the day-to-day conduct or analysis of the trial. The committee will review, in a highly confidential process, unblinded data for safety and efficacy futility from all available participant visits including many who will have completed the 36- week treatment period.

“Unblinded data” refers to data tables, figures and listings where the assignment of participants to Xanamem or the placebo control treatment will be known only to the DMC members. It will then make a recommendation to the Company about the continuation and conduct of the trial without disclosing details of the data review.

While Xanamem’s safety is carefully monitored throughout the trial in an ongoing process, DMC review of unblinded safety data will add a significant amount of additional information to ensure the conduct of the trial is optimal.

An “efficacy futility” analysis will review key efficacy endpoints to ensure that the eventual outcome of the trial is not futile according to customary analytic methods for DMC reviews of this type. The DMC may not stop the trial early for ‘success’ and would recommend stopping the trial only if the futility criteria are met or there are major safety concerns. Actinogen believes that fully enrolling the 220 planned participants will ensure that the safety and efficacy of oral Xanamem 10 mg daily will be robustly demonstrated and as a result support the earliest possible regulatory approval of the drug.

During the second half of 2025, the Actinogen clinical, nonclinical, manufacturing and regulatory teams will meet with the US FDA1 to discuss the detailed potential pathways to FDA approval of Xanamem for Alzheimer’s disease, including expedited pathways should the XanaMIA trial show much stronger efficacy and safety than currently available treatments. As a base case, Actinogen is planning its regulatory approval pathways according to “conventional” oral therapy guidelines for important and common diseases such as AD. The next, phase 3 stage of development may involve one or more commercial partnerships to assist in trial conduct, regulatory submissions and commercial launch preparation.

Oral Xanamem is a unique treatment approach that targets control of cortisol levels in brain regions relevant to memory and cognitive function where the 11-β HSD1 enzyme is highly expressed. It has the potential to be used alone or in combination with other approved treatments because of its low drug interaction potential and the ease and convenience of a once-daily pill.

Summary of Xanamem’s Alzheimer’s disease program timeline:

  • H2 2025 – FDA meeting to review planned program for US regulatory approval
  • Q4 2025 or January 2026 – Full enrolment of 220 XanaMIA phase 2b/3 trial participants
  • January 2026 – Independent DMC review of safety and efficacy data for XanaMIA
  • Q1 2026 – Open-label extension trial enrols the first patient following on from XanaMIA
  • Q4 2026 – Final XanaMIA results announced
  • Q1 2027 – Commencement of second pivotal, phase 3 trial.

Actinogen Chief Executive Officer, Dr Steven Gourlay, said:

“We are delighted to confirm the timeline for our independent Data Monitoring Committee review of safety and efficacy data based on the enrolment of the 100th patient in the XanaMIA phase 2b/3 Alzheimer’s trial. This confidential review of unblinded data will ensure the XanaMIA trial is on-track and that Xanamem continues to perform as a promising and well-tolerated, once-a-day oral therapy.”

“Furthermore, with our 35 Australian and US clinical sites now enrolling at full pace, we are able to reconfirm our guidance for final results in late 2026. The availability of a follow-on, open-label trial where all will receive active Xanamem therapy should give participants and their families more incentive to participate in the current XanaMIA trial as well as provide valuable long-term safety and efficacy data.”


Click here for the full ASX Release

This article includes content from Actinogen, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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