Actinogen provides pivotal Alzheimer’s trial enrolment update and other business news

Core Insights - Actinogen Medical Limited is progressing with its Phase 2b/3 trial for Alzheimer's disease, expecting to enroll 100 participants by the end of the current quarter, which will trigger an interim analysis in approximately six months [1][2][3] Group 1: Trial Progress and Design - The XanaMIA trial is designed to enroll 220 participants with biomarker-positive, mild to moderate Alzheimer's disease, specifically those with elevated blood biomarker pTau181 [2][13] - Currently, 60 participants have entered the treatment phase, with an additional 35 expected to enroll soon as recruitment accelerates with new clinical sites in the US, bringing the total to 35 sites [3][13] - The primary endpoint of the trial is the Clinical Dementia Rating – Sum of Boxes scale, with additional measures assessing cognition and functional ability [2][13] Group 2: FDA Interactions and Future Plans - Actinogen had a successful meeting with the FDA regarding its Major Depressive Disorder (MDD) program, which provided guidance for additional clinical trials needed for marketing approval of Xanamem [4][5] - A similar Type C meeting for Alzheimer's disease is scheduled with the FDA's Neurology Division later in 2025 to outline the path to marketing approval [5] Group 3: Mechanism and Future Applications - Xanamem, the lead compound, aims to control cortisol levels in the brain, which is linked to cognitive decline and depressive symptoms [15][16] - The company plans to explore Xanamem's potential in treating other neurological and psychiatric conditions, including Fragile X Syndrome [12][15] Group 4: Upcoming Events and Engagement - Actinogen will host a Clinical Trials Science Forum webinar on May 14, 2025, to discuss current and potential treatments for Alzheimer's disease and commercialization planning [7][8]