Actinogen Medical - Refining the upcoming XanaMIA Phase IIb study

Actinogen intends to start patient enrolment and dosing in H2 CY23 in the Phase IIb XanaMIA study portion assessing Xanamem in lead indication Alzheimer’s disease (AD). The company expects to receive FDA approval in the coming weeks on amendments to the study design protocol and the new Xanamem tablet formulation to be used (replacing the capsule used in prior Xanamem trials). It expects to report top-line efficacy data in H2 CY25, with interim readouts projected in or around late CY24 or early CY25. We believe market participants will be keen to observe whether this study, which prospectively enrols patients with elevated pTau, will confirm the positive findings shown in a subset biomarker analysis from the earlier XanADu study. Positive Phase IIb data could introduce the possibility of material out-licensing or value realisation opportunities, in our view.