Actinogen Medical keeps pivotal Alzheimer’s trial on track for November readout

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) has maintained momentum across its clinical, regulatory and commercial programs during the June quarter, with its pivotal XanaMIA Alzheimer’s disease trial on schedule to deliver topline results in November 2026.

The fully enrolled Phase 2b/3 trial continued treatment and follow-up activities across participating sites, while an independent Data Monitoring Committee completed its third review of safety data from all 247 participants and recommended the study continue without amendment. 

Actinogen ended the quarter with $16.7 million in cash, providing funding beyond the XanaMIA readout and into mid-2027.

Strong uptake in open-label extension

Enrolment in the XanaMIA open-label extension advanced following its launch on March 31, with 81 patients now receiving treatment.

Around 88% of participants completing the randomised trial have elected to immediately continue into the extension, where all patients receive Xanamem 10 milligrams once daily for up to 25 months.

The extension is designed to provide longer-term safety information and observational data across key measures including cognition, activities of daily living and the Clinical Dementia Rating Scale–Sum of Boxes.

These findings are expected to contribute to future regulatory marketing applications.

Regulatory pathway gains clarity

Actinogen also received positive scientific advice from the European Medicines Agency, broadly aligning with feedback previously provided by the US Food and Drug Administration.

The discussions established a common understanding around commercial manufacturing materials, safety database requirements and the design of an additional pivotal Phase 3 trial following a positive XanaMIA outcome.

A limited number of supporting clinical pharmacology and non-clinical studies would be conducted alongside future development work.

For planning purposes, Actinogen continues to assume a second pivotal trial will be required, although the company intends to explore whether approval could be sought on the basis of a single pivotal trial if the November results are sufficiently strong.

The regulatory feedback is also expected to support partnering discussions by providing greater clarity around Xanamem’s path towards potential approval in major markets.

Depression data supports broader potential

Results from Actinogen’s Phase 2 proof-of-concept study of Xanamem in patients with major depressive disorder and cognitive impairment were published in the peer-reviewed British Journal of Psychiatry.

The study reported encouraging antidepressant activity in a difficult-to-treat patient population, with the strongest response seen among patients receiving background standard-of-care antidepressant therapy.

Xanamem produced clinically significant, and at times statistically significant, improvements in depression scores compared with placebo and remained safe and well tolerated.

Actinogen said the findings support further development of Xanamem in depression and provide additional validation of the drug’s cortisol-control mechanism.

Patent portfolio strengthened

The company continued expanding its intellectual property position during the quarter, securing initial national acceptances for patents covering the treatment of cognitive decline in healthy elderly people and key Xanamem manufacturing processes.

Acceptances were received in Australia and Russia for cognitive decline applications, and in China, Chile and Russia for manufacturing-related protections.

Actinogen is also pursuing patents covering depression treatment, tablet formulations and methods for identifying suitable patients.

Commercial preparations accelerate

With the pivotal XanaMIA results approaching, Actinogen stepped up engagement with Alzheimer’s disease specialists, investors and potential commercial partners.

The company presented trial information at the Alzheimer’s Association International Conference in London and the Australian Dementia Research Forum in Sydney.

Management said interest from potential global and regional commercialisation partners continued to grow, with discussions aimed at positioning interested parties to assess the program quickly before and after the November readout.

Financial position supports key catalyst

Actinogen recorded operating expenditure of about $5 million during the quarter, primarily related to the XanaMIA trial and participation in the open-label extension.

The company closed the period with $16.7 million in cash and expects additional receipts from its research and development tax rebate later in 2026, net of associated loan repayments.

This provides Actinogen with a cash runway to mid-2027 and beyond the pivotal XanaMIA topline results.

Next steps

Actinogen’s immediate focus is completing the XanaMIA Phase 2b/3 trial and reporting topline results in November 2026.

A positive outcome would support preparations for the final pivotal development program, further regulatory engagement and potentially accelerated partnering discussions across major global markets.

About Actinogen Medical

Actinogen Medical is developing therapies for neurological and neuropsychiatric conditions associated with dysregulated cortisol in the brain.

Its lead compound, Xanamem, is a once-daily oral treatment designed to reduce cortisol production within key brain regions by inhibiting the enzyme 11β-HSD1.

The company’s primary focus is Alzheimer’s disease, while clinical work has also explored Xanamem’s potential in major depressive disorder and cognitive impairment.

Xanamem remains an investigational therapy and has not been approved for use outside clinical trials.