Actinogen has treated the first participant in the open-label extension (OLE) segment of its Phase IIb/III pivotal XanaMIA Alzheimer’s disease trial after completion of 36 weeks in the randomised phase.
The extension allows eligible participants to receive active Xanamem 10mg once a day for up to 25 months and will run without a placebo control group.
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The open-label phase is available to former and current participants who have concluded the randomised portion of the study in the US and Australia.
It is designed to collect longer-term safety data and observational information on efficacy measures, including clinical dementia rating scale-sum of boxes (CDR-SB), cognition and activities of daily living.
Actinogen stated that data from the extension will be analysed and reported on a rolling basis. The company plans to compare findings with relevant historical control cohorts involving patients with mild to moderate Alzheimer’s, as well as with data generated during the randomised stage of the trial.
The randomised phase is continuing alongside the extension after the Independent Data Monitoring Committee issued an efficacy and positive safety futility recommendation in January 2026.
Actinogen anticipates final topline efficacy and safety results for the full 36-week treatment period in November 2026.
XanaMIA is planned as one of two pivotal studies intended to support the earliest possible marketing approvals for Xanamem in Alzheimer’s.
If positive, Actinogen plans to explore accelerated approval pathways with regulators, including the US Food and Drug Administration (FDA).
The company also plans a meeting with the European Medicines Agency (EMA) this quarter and expects near-term publication of XanaCIDD Phase IIa depression trial results.
Actinogen Medical CMO Dr Dana Hilt said: “The commencement of the open-label extension phase of the XanaMIA trial enables us to offer current and past participants access to active Xanamem therapy for up to 25 months.
“Xanamem has the potential to be a game-changer for patients with Alzheimer’s as a potentially safe and effective oral therapy to slow or halt disease progression. Unlike anti-amyloid antibody therapies, Xanamem does not require serial MRI monitoring for safety as there is no suggestion it causes brain swelling, also known as ARIA.”
In April 2024, Actinogen Medical finished enrolling subjects in the Phase IIa XanaCIDD clinical trial of Xanamem for treating cognitive impairment associated with major depressive disorder (MDD).
