Actinogen Medical Limited CEO Dr Steven Gourlay will conduct a series of meetings at the BIO Investor Forum, San Francisco on October 17-18, 2023. The following week, Dr Gourlay and CMO Dr Dana Hilt will participate in the 16th annual CTAD conference in Boston where they will present a scientific poster on October 25 and conduct a number of stakeholders meetings. Dr Gourlay and Dr Hilt will be discussing progress made with the Company's two ongoing Phase 2 trials: XanaCIDD Phase 2a trial in patients with cognitive impairment and major depressive disorder: Enrolment continues in the XanaCIDD Phase 2a proof-of-concept trial in 160 patients with cognitive impairment associated with persistent Major Depressive Disorder (MDD).

Cognitive impairment is common in MDD and currently there are no anti-depressant drugs approved for its treatment, although some companies have reported trials to assess effects of their anti-depressants on cognition. Consequently, there is a high unmet need for novel and safe treatments for this indication. The trial is being conducted in Australia, the UK and the USA.

It is treating patients with 10 mg of Xanamem or placebo once daily for six weeks as monotherapy or added to stable background anti-depressant therapy. The primary endpoint is an attention composite of three computerized cognitive tests measuring attention and working memory. Depression is assessed as a key secondary endpoint using the MADRS scale.

The trial is expected to report results in the first half of 2024. On 26 September Actinogen announced that it had redesigned operational features of the XanaMIA Phase 2b clinical trial of Xanamem in patients with mild to moderate AD to reduce the cost and time to initial results. Key features of the revised XanaMIA Phase 2b trial: The trial will enrol patients with an elevated blood pTau biomarker (the same group shown to have a large Xanamem clinical effect in the previous Phase 2a biomarker trial) and keeps the same endpoints and 36-week treatment length.

The removal of the 5mg dose arm reduces patient numbers by one-third to 220 patients, who will receive either 10mg or placebo daily, Enrolment of the first 100 patients will take place at Australian sites and initial efficacy and safety results from an administrative interim analysis will occur when approximately 100 patients reach 24 weeks of treatment, expected in the first half of 2025, 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 AUD 30 million compared to the original plan, The XanaMIA Phase 2b trial will finalize Australian clinical site start up activities as soon as possible, with site activation expected before the end of the year, Final results are anticipated in the second half of 2025.