Actinogen Medical (ASX: ACW) has optimized the design of the XanaMIA Phase 2b Alzheimer's disease trial to expedite results and reduce costs. The FDA-approved three-arm trial aimed at confirming Xanamem®'s safety and clinical benefits remains unchanged, except for the elimination of the 5 mg dose group, postponing dose-ranging to a potential Phase 3 trial. The trial still demonstrates Xanamem's clinical benefit in Alzheimer's patients.
Changes include a 10 mg or placebo daily regimen, a reduced cohort of 220 patients with elevated blood pTau biomarkers (previously 330 patients), Australian sites enrolling the initial 100 patients, and an interim analysis at 24 weeks for initial efficacy and safety results. These modifications are expected to save approximately $30 million by June 2025. Further expansion depends on data from the XanaCIDD trial in mid-2024 and the redesigned XanaMIA interim analysis in H1 2025. Patient recruitment for XanaMIA Phase 2b is set to begin by year-end, building on Xanamem's established safety profile from over 300 participants.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 21, 2024
Nov 20, 2024
Nov 20, 2024
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
