• Open-label extension phase of up to 25 months treatment with Xanamem 10 mg
• Open to all former and current participants of XanaMIA pivotal trial
• Generates longer-term safety and efficacy data for Xanamem

Actinogen Medical has announced the commencement of the open-label extension (OLE) phase of the XanaMIA Alzheimer's disease trial. The OLE phase will provide up to 25 months of treatment with Xanamem 10 mg once daily to all former and current participants of the XanaMIA pivotal trial, which is currently ongoing in Australia and the US. This open-label phase will generate longer-term safety data and observational data on key efficacy endpoints such as the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB), cognition, and activities of daily living. The trial data will provide valuable information to support future regulatory marketing applications for Xanamem. Unlike anti-amyloid antibody therapy, Xanamem does not require serial MRI scanning for safety evaluations as there is no suggestion it causes brain swelling. The randomized phase of the XanaMIA trial continues in parallel, with final topline results expected in November 2026.

The open-label extension phase of the XanaMIA Alzheimer's trial will provide longer-term safety and efficacy data for Xanamem, which has the potential to be a game-changer for Alzheimer's patients as a potentially safe and effective oral therapy to slow or halt disease progression.