The TOS results are critical to what happens next.
What was the TOS? Subjects: 50% healthy, 50% AD Duration of dosing: 7 days Doses (mg/day): 5, 10, 20, 30 PET scans of the brain at baseline and after 7 days.
Results: Detailed results of the TOS haven't been released. Some partial results have been released in presentations.
MD presentation 25 November 2020: "10-30 mg Xanamem dosed for seven days significantly occupies the neuronal 11B-HSD1 enzyme throughout the brain. 50%-85% occupancy, dependent upon brain region, dosage and study subject. Additional ongoing cohorts at 5 mg and 10 mg with delayed PET imaging". Potential next Xanamem trial: MCI at 20 mg.
Strategic update 21 April 2021: "PET data demonstrates that Xanamem extensively binds to the 11B-HSD1 enzyme throughout the brain, with high post-treatment effects (absence of colour) after 7 days at all doses, even a 5 mg Xanamem dose. This is consistent with full hormonal pharmacodynamic activity seen with 10 mg Xanamem in clinical trials. Actinogen is seeking to confirm the minimum effective dose of Xanamem to use going forward". Will start dose escalation study at 5 mg.
Because the detailed TOS results haven't been released, shareholders are forced to rely on the partial TOS results in the presentations.
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