Actinogen Medical Limited announced that enrolment in the XanaCIDD Phase 2a proof-of-concept trial in 160 participants with cognitive impairment associated with persistent major depressive disorder (MDD) now exceeds 50% (that is, more than 80 participants enrolled to date). Results remain on track for release in the second quarter of 2024. Highlights of XanaCIDD trial: Double-blind, placebo-controlled randomized trial design; 10mg Xanamem®?

daily dose versus placebo for six weeks (a common duration for Phase 2a trials in MDD); Participants have a history of persistent MDD despite previous treatment and objective cognitive impairment; The primary endpoint for the trial is the computerized Cogstate "attention composite" test battery, measuring attention and working memory and shown previously to be a sensitive measure of Xanamem benefit in the XanaMIA Part A and XanaHES trials; The key secondary endpoint for the trial is the MADRS structured interview evaluating MDD symptoms and is a fundamental endpoint used for regulatory approvals of anti-depressant medication; Recruitment in the UK is now accelerating (previously site activation was impacted by industry-wide delays at the UK regulator); Recruitment in Australia is further accelerating due to enhanced screening and recruitment procedures. XanaMIA Phase 2b Alzheimer's disease trial site activation imminent and interim analysis on track for the first half of 2025: Clinical site startup activities continue at Australian sites for the XanaMIA Phase 2b Alzheimer's disease trial. Patient recruitment is expected to commence before the end of the year.

The trial will enrol 220 participants with mild to moderate Alzheimer's disease and elevated blood pTau evenly randomized to treatment with 10mg of Xanamem or matching placebo daily for 36 weeks. When approximately 100 patients reach 24 weeks of treatment, the Company will conduct an interim analysis and is expected to announce the results of that analysis in the first half of 2025. Final results are anticipated in the second half of 2025.