First Patient Treated in Actinogen's XanaMIA Phase 2b Alzheimer's Trial

Actinogen Medical Limited has begun treating the first participant in its XanaMIA phase 2b clinical trial, targeting individuals with mild to moderate Alzheimer’s disease (AD) with biomarker-positive pTau levels. This trial represents an important milestone as it transitions from initial setup to active patient treatment across multiple clinical sites. The study, using a double-blind, placebo-controlled design, will involve 220 participants and will assess the impact of a daily 10 mg dose of Xanamem® on cognitive abilities and overall function over a 36-week period.

The primary goal is to evaluate cognitive improvement through a comprehensive digital test battery consisting of seven assessments. Previous studies have indicated positive cognitive outcomes with Xanamem. A key secondary measure, the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), will also be utilized, acknowledging its widespread acceptance by regulatory bodies like the FDA. Earlier analysis of Xanamem-treated patients with mild AD showed significant cognitive improvements and favorable changes in the CDR-SB metric. Additional secondary outcomes will include evaluations of daily living activities.

Clinical trials are taking place at thirteen sites within Australia, with plans to extend to the USA later. Interim results are expected by mid-2025, with the full study completion anticipated in the first half of 2026.

Dr. Steven Gourlay, CEO of Actinogen, expressed satisfaction with the trial's progression, citing prior encouraging safety and efficacy data related to Xanamem. He anticipates that this trial will offer robust clinical and statistical backing for the drug’s benefits.

Moreover, Actinogen has secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) for Xanamem. This status aims to expedite market entry and involves creating a Target Development Profile (TDP) in collaboration with various stakeholders, including the MHRA and the National Institute for Health and Care Excellence (NICE).

The company is also nearing completion of patient enrolment for the XanaCIDD Phase 2a trial, focused on Major Depressive Disorder (MDD) with cognitive impairment. This trial, employing a similar double-blind, placebo-controlled design, involves adding Xanamem to existing antidepressant treatments for a duration of six weeks. Efficacy is primarily measured through the "Attention Composite" score on the Cogstate Cognitive Test Battery and the Montgomery-Asberg Depression Rating Scale. Results are anticipated in early Q3 2024.

Actinogen Medical is an ASX-listed biotechnology company dedicated to developing innovative therapies for neurological and neuropsychiatric disorders influenced by dysregulated cortisol levels. Xanamem, the lead compound, is being studied extensively for its potential to treat Alzheimer’s Disease and Depression, with plans to explore additional applications in Fragile X Syndrome and other conditions. Xanamem works by inhibiting the 11β-HSD1 enzyme, reducing cortisol production within brain cells, and has shown promise in improving cognitive and functional abilities in early trials.

Current clinical trials include the XanaCIDD Phase 2a trial for depression and the XanaMIA Phase 2b trial for Alzheimer’s, aimed at evaluating Xanamem's efficacy as both a cognitive enhancer and a disease-modifying treatment. Initial findings have demonstrated significant improvements in working memory and attention in both healthy older adults and individuals with mild AD. However, Xanamem remains investigational and is not yet approved for general medical use outside clinical trials.