Actinogen Medical Limited announced optimization of the XanaMIA Phase 2b trial in patients with mild-to-moderate Alzheimer's disease to reduce the cost and time to initial results. The current, FDA-approved three-arm trial was designed to confirm the safety, pro-cognitive and clinical benefits of Xanamem® and explore two dose levels. The new design keeps the same endpoints, 36-week treatment length and other features except for the 5 mg dose group.

Operationally, the trial has been streamlined with the following modifications: New: 10 mg or placebo daily vs. 10 mg, 5 mg or placebo previously. New: 220 patients vs.

330 patients previously but still studying patients with the elevated blood pTau biomarker (the same group shown to have a large Xanamem clinical effect in the previous Phase 2a biomarker trial). New: Australian sites to enroll the first 100 patients vs. simultaneous global site activation previously.

New: Initial efficacy and safety results from an administrative interim analysis when approximately 100 patients reach 24 weeks of treatment vs. unspecified previously. Collectively these changes reduce trial costs significantly and increase forecast receipts from Australian R&D tax incentive cash refunds by focusing on Australian R&D activities in the near term.

Net forecast savings between now and June 2025 will be in the order of $30 million compared to the original plan. The new implementation plan assumes that expansion of the XanaMIA trial will occur when potentially new, positive clinical data is received from the XanaCIDD trial by mid-2024 and/or the redesigned XanaMIA interim analysis, planned for the first half of 2025. Xanamem's promising safety profile has been demonstrated in more than 300 people to date.

The XanaMIA Phase 2b trial will finalize Australian clinical site start up activities as soon as possible with patient recruitment expected before the end of the year. General Business Update: XanaCIDD Phase 2a trial: The Company announced that it has expanded the XanaCIDD Phase 2a randomized clinical trial in patients with cognitive impairment associated with depressive disorder (CIDD) from Australia to include UK sites, which have commenced screening. The XanaCIDD Phase 2a depression trial is a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 160 patients with both depression and cognitive impairment.

Patients are evenly randomized to receive Xanamem 10 mg once daily or placebo, in some cases in addition to their existing antidepressant therapy, and effects on cognition and depression are assessed. Results of the XanaCIDD trial are anticipated by mid-2024. Current and Upcoming Clinical Trials: The XanaCIDD Phase 2a depression trial is a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 160 patients.

Patients are evenly randomized to receive Xanamem 10 mg once daily or placebo, in some cases in addition to their existing antidepressant therapy, and effects on cognition and depression are assessed. The XanaMIA Phase 2b Alzheimer's disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 protein biomarker in blood. Patients receive Xanamem 10 mg or placebo, once daily, and effects on cognition, function and progression of Alzheimer's disease are assessed.

Thus, Xanamem is being assessed in this trial for its potential effects as a both a cognitive enhancer and a disease course modifier.