Actinogen Medical - First patient dosed in Phase IIb XanaMIA study

Actinogen Medical announced that the first randomised patient in its Phase IIb XanaMIA trial of lead candidate Xanamem received their first treatment on Friday 12 April. This study is designed to enrol c 220 patients with cognitive impairment (CI) associated with biomarker-positive mild-to-moderate Alzheimer’s disease (AD), as confirmed through an elevated level of phosphorylated Tau-181 (pTau-181) protein in their blood at baseline. The study has commenced at 13 Australian sites and will concentrate on domestic sites for the first c 100 patients, and initial efficacy and safety results will be analysed when these patients reach 24 weeks of treatment. These results are now expected in mid-CY25 (vs prior guidance of H1 CY25) and Actinogen expects to expand the trial to US study sites following this interim readout. In the near term, the next material milestone for the company will be results, now expected in early Q3 CY24 (vs Q2 CY24 previously), from its Phase IIa XanaCIDD study in patients with CI and major depressive disorder (MDD).