• XanaMIA trial now fully enrolled with 246 participants
• Topline results expected in November 2026
• Interim analysis by independent DMC in late January 2026
• Open-label extension phase to commence in Q1 2026

Actinogen Medical has announced that the XanaMIA phase 2b/3 Alzheimer's disease trial has now fully enrolled, with 246 participants randomized and commenced on treatment. This exceeds the original target of 220 participants, accounting for expected discontinuations. The robust recent enrolment validates the attractiveness of Xanamem as a potential treatment for Alzheimer's disease. The trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design, assessing Xanamem 10 mg versus placebo in patients with mild to moderate Alzheimer's disease and progressive disease, confirmed by elevated pTau181 levels. The primary endpoint is the internationally-recognized CDR-SB (Clinical Dementia Rating scale - Sum of Boxes). Topline, final results are now confirmed for November 2026, with full analysis completed in the months following. An independent Data Monitoring Committee (DMC) will conduct a formal interim analysis of safety and efficacy futility from the partially completed trial in late January 2026. All past and present participants in the trial will be eligible to receive active Xanamem 10 mg treatment in the open-label extension phase commencing in Q1 2026.

The Company will be conducting the formal interim analysis of the XanaMIA trial in January 2026, interacting with the European Medicines Agency on the path to approval in the EU, and planning for the upcoming clinical and manufacturing programs. Xanamem has the potential to be a game-changer for Alzheimer's patients because of its safety, ease-of-use and potential efficacy advantages.