Actinogen Medical Ltd. has announced the enrollment of the 100th participant in its XanaMIA phase 2b/3 trial of Xanamem® for Alzheimer's disease. The company plans an interim analysis in January 2026, with final trial results expected in late 2026. An independent Data Monitoring Committee will review patient data during the interim analysis to ensure the trial's safety and efficacy. Additionally, Actinogen is preparing for a Type C meeting with the FDA in the second half of 2025 to discuss regulatory approval pathways for Xanamem, including potential expedited pathways if the trial demonstrates strong efficacy and safety. The full enrollment target is set at 220 participants to robustly demonstrate the safety and efficacy of the oral Xanamem 10mg daily dosage. Results from the trial have not yet been presented and are anticipated in the future.
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