Actinogen Medical - Publication of XanADu biomarker analysis

Actinogen Medical announced that the prespecified biomarker subset analyses on stored plasma samples (n=72) from its previous Phase IIa XanADu study (n=185) in patients with mild Alzheimer’s disease (AD) has been published in the peer-reviewed Journal of Alzheimer’s Disease (JAD). As reported in Q422, patients with elevated baseline phosphorylated Tau-181 (pTau-181) protein (at least 6.74pg/mL), representing 34 patients (16 on Xanamem 10mg daily, 18 on placebo), showed a 0.6 mean difference (effect size) on the CDR-SB scale at 12 weeks between the placebo and treatment arms, representing a 60% relative reduction in progression. This suggests that Xanamem’s potential cognitive or disease-slowing effects may be sensitively detected by the CDR-SB endpoint, which is one of the critical endpoints in the ongoing XanaMIA Phase IIb trial (planned n=220) enrolling participants with cognitive impairment (CI) in mild to moderate AD as confirmed through elevated baseline p-Tau181. Actinogen’s next milestone will be results, expected in early Q3 CY24, from its Phase IIa XanaCIDD study of Xanamem in patients with CI and major depressive disorder.