Actinogen achieves agreement with the FDA in a Type C meeting on the manufacturing, clinical and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease

Core Insights - Actinogen Medical Limited is progressing with its pivotal phase 2/3 trial for Xanamem, targeting Alzheimer's disease, with interim analysis expected in January 2026 and final results anticipated in late 2026 [1][2] - The company has reached a significant agreement with the FDA regarding the pathway to marketing approval for Xanamem, which includes the design of an additional pivotal clinical trial and a limited number of ancillary studies [2][3] Group 1: Regulatory Developments - The FDA meeting confirmed the regulatory starting materials for drug substance synthesis and the design of one additional pivotal clinical trial [2][6] - Actinogen plans to submit a New Drug Application (NDA) in the US and to other global regulators, following the FDA's guidance [2][3] - A similar meeting with the European Medicines Agency is scheduled for 2026, indicating a global regulatory strategy [3] Group 2: Clinical Trial Details - The ongoing XanaMIA trial involves 220 participants with mild to moderate Alzheimer's disease and is currently enrolling in Australia and the US [7] - The pivotal trial will utilize a single 10 mg dose of Xanamem compared to a placebo, as agreed upon with the FDA [4][6] - The trial design includes a small number of ancillary clinical pharmacology trials and nonclinical studies to further characterize Xanamem [6] Group 3: Product Information - Xanamem (emestedastat) is a novel oral therapy designed to control cortisol levels in the brain, which is linked to Alzheimer's disease progression and depressive symptoms [8] - The drug has shown promising safety and efficacy in previous clinical trials, with over 400 participants treated [7][8] - Xanamem's mechanism of action involves inhibiting the cortisol synthesis enzyme 11β-HSD1, targeting areas of the brain where cortisol is known to be toxic [8]