Actinogen Optimizes XanaMIA Phase 2b Alzheimer's Disease Trial Design
Actinogen Medical Limited (ASX: ACW) has optimized its XanaMIA Phase 2b trial for patients with mild-to-moderate Alzheimer’s disease, aiming to reduce costs and accelerate the time to initial results. The trial's design has been streamlined by removing the 5 mg dose group, focusing instead on a 10 mg dose or placebo daily, and reducing the number of patients from 330 to 220. These changes are expected to save AUD 30 million over the next two years while maintaining the trial's 36-week design and endpoints.
The XanaMIA trial will now prioritize Australian sites for the enrollment of the first 100 patients, with an administrative interim analysis planned when approximately 100 patients reach 24 weeks of treatment. This approach is anticipated to increase forecast receipts from Australian R&D tax incentive cash refunds by concentrating on Australian R&D activities in the near term.
In addition to the XanaMIA trial updates, Actinogen has expanded its XanaCIDD Phase 2a trial, which investigates cognitive impairment associated with depressive disorder (CIDD), to include UK sites. The XanaCIDD trial is a double-blind, six-week, placebo-controlled study involving 160 patients, with results expected by mid-2024.
Actinogen's lead compound, Xanamem®, targets the inhibition of the 11β-HSD1 enzyme in the brain to reduce cortisol levels, which are associated with cognitive decline in Alzheimer’s Disease and other neurological and psychiatric diseases. The company has demonstrated Xanamem's promising safety profile in over 300 individuals and is conducting a series of Phase 2 studies to further explore its therapeutic potential.
Actinogen Medical is an ASX-listed biotechnology company focused on developing novel therapies for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. The company's efforts are directed towards addressing the substantial unmet medical need for new and improved treatments in these areas.