Australian biotechnology firm Actinogen Medical (ASX:ACW) has reached a clinical milestone, announcing the commencement of the open-label extension phase for its pivotal XanaMIA trial.
The transition follows the treatment of the first participant in the new phase, which offers long-term access to the company’s lead oral therapy, Xanamem, for those who have completed the initial 36-week randomised period.
The OLE phase is designed to run for up to 25 months, providing active 10 mg daily doses to all participants—including those previously assigned to the placebo group—across clinical sites in Australia and the United States.
Beyond offering extended therapy, the extension will generate critical longitudinal data regarding the drug's safety profile and its impact on disease progression markers, such as the Clinical Dementia Rating Scale.
Chief Medical Officer Dr Dana Hilt highlighted that, unlike traditional anti-amyloid treatments, Xanamem’s unique mechanism does not appear to cause brain swelling, potentially eliminating the need for intensive MRI monitoring.
As the company progresses towards a pivotal November deadline for topline results, leadership remains focused on global regulatory alignment.
CEO Dr Steven Gourlay noted that the firm is preparing for discussions with the European Medicines Agency this quarter to streamline approval pathways, mirroring successful engagements with the FDA.