Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) is approaching a potentially defining catalyst for its lead Alzheimer’s disease therapy Xanamem, with topline results from the pivotal XanaMIA Phase 2b/3 trial expected in November 2026.
The company noted in its FY26 results that the study remained on track after three positive Independent Data Monitoring Committee recommendations, including a confidential non-futility review of unblinded efficacy data in January.
Actinogen has also strengthened its regulatory pathway during the year, reaching common understandings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on potential pathways to marketing approval.
This includes agreement on a streamlined design for one further pivotal Alzheimer’s disease trial of Xanamem 10 milligrams versus placebo, planned to begin in 2027.
“FY2026 has been a defining year for Actinogen. We achieved every major objective we set ourselves, including timely enrolment of the pivotal XanaMIA Alzheimer’s disease trial and its successful interim efficacy futility and safety review, securing alignment with both the FDA and EMA on relatively streamlined pathways to marketing approvals, and establishing a cash runway beyond mid-2027,” Actinogen CEO, Dr Steven Gourlay said.
“Xanamem is a leading and unique late-stage oral therapy in clinical development for Alzheimer’s disease with the potential to become a transformational treatment option for patients and their families living with this devastating condition. Our key focus is to deliver high-quality pivotal trial results in November while at the same time planning the future activities needed to get Xanamem approved as soon as possible by regulators."
XanaMIA results become key near-term catalyst
The XanaMIA Phase 2b/3 study is evaluating Xanamem in 247 patients with mild to moderate Alzheimer’s disease across Australia and the US.
Patients receive either Xanamem 10 milligrams or placebo once daily for 36 weeks, with the primary endpoint measuring changes using the Clinical Dementia Rating – Sum of Boxes scale.
Recruitment has now closed and final topline results are expected in November.
Actinogen also began an open-label extension of XanaMIA in March, allowing participants to receive active Xanamem. Around 89% of eligible participants moved directly into the extension at the end of the main trial, with 108 patients on treatment at the time of the company’s update.
Xanamem is designed to control elevated cortisol levels in the brain by inhibiting the 11β-HSD1 enzyme, with Actinogen targeting neurological and neuropsychiatric diseases associated with dysregulated brain cortisol.
Cash runway extends beyond trial readout
Actinogen finished June with cash and cash equivalents of $16.7 million, providing funding beyond the XanaMIA results and into mid-2027.
The company reported a statutory net loss after tax of $15.4 million for the year, compared with a $14.7 million loss a year earlier, reflecting continued investment in Xanamem.
Research and development expenditure increased to $19.0 million from $12.3 million, mainly due to clinical trial activity.
Looking ahead, Actinogen’s priorities are completing XanaMIA and delivering the November dataset, preparing for the next stage of clinical and regulatory development and pursuing strategic partnership opportunities for Xanamem.