Actinogen Medical (ASX:ACW) has hit a significant milestone in its push to bring a new oral Alzheimer’s therapy to market, completing enrolment in its pivotal XanaMIA trial and confirming November 2026 for topline results.
The company said it has now randomised and commenced treatment for 246 patients with mild to moderate Alzheimer’s disease, exceeding its original 220‑patient target, thereby boosting the study's statistical power.
Xanamem (emestedastat) is a once‑daily pill that targets excess cortisol in the brain by inhibiting the 11β‑HSD1 enzyme, aiming to slow cognitive decline without disturbing essential systemic cortisol production. Prior data include high brain target engagement on PET imaging, a meaningful CDR‑SB benefit over 12 weeks in biomarker‑positive Alzheimer’s patients from the earlier XanADu trial, and statistically and clinically significant improvements in depressive symptoms in the phase 2 XanaCIDD depression study.
XanaMIA is a double‑blind, placebo‑controlled phase 2b/3 trial in Australia and the US, using elevated plasma pTau181 to confirm diagnosis and CDR‑SB at 36 weeks as the primary endpoint. An independent Data Monitoring Committee will run a confidential interim futility and safety analysis in late January 2026, while an open‑label extension starting in early 2026 will offer up to 25 months of active Xanamem to all past and current trial participants, generating longer‑term safety and observational efficacy data.
Actinogen is positioning Xanamem against a landscape where existing symptomatic drugs offer limited benefit and anti‑amyloid infusions are costly, invasive and associated with safety burdens, yet only modestly slow decline.
The company argues a safe, convenient oral therapy with a distinct mechanism could be used alongside or ahead of current treatments, and says market research with US Alzheimer’s specialists suggests rapid uptake if efficacy is confirmed.