ACW 100th AD trial participant & interim analysis timeline
| Stock | Actinogen Medical Ltd (ACW.ASX) |
|---|---|
| Release Time | 30 Jun 2025, 8:57 a.m. |
| Price Sensitive | Yes |
Actinogen confirms 100th participant in Alzheimer's trial
- 100th participant enrolled in XanaMIA phase 2b/3 Alzheimer's trial
- Interim analysis timeline confirmed, with DMC review in January 2026
- Final trial results expected in Q4 2026
Actinogen Medical has announced 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) 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 will review unblinded data for safety and efficacy futility from all available participant visits, including many who will have completed the 36-week treatment period. While Xanamem's safety is carefully monitored throughout the trial, the DMC review will add significant additional information to ensure the optimal conduct of the trial. An 'efficacy futility' analysis will review key efficacy endpoints to ensure the eventual outcome of the trial is not futile. The DMC may only recommend stopping the trial if the futility criteria are met or there are major safety concerns. Actinogen believes that fully enrolling the 220 planned participants will ensure the safety and efficacy of oral Xanamem 10 mg daily will be robustly demonstrated, supporting the earliest possible regulatory approval. The Company will also meet with the US FDA in the second half of 2025 to discuss potential approval pathways, including expedited options if the trial shows stronger efficacy and safety than currently available treatments.
Actinogen is planning its regulatory approval pathways for Xanamem according to 'conventional' oral therapy guidelines for Alzheimer's disease. 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.