ACW achieves early screening closure for XanaMIA trial
| Stock | Actinogen Medical Ltd (ACW.ASX) |
|---|---|
| Release Time | 20 Oct 2025, 9:04 a.m. |
| Price Sensitive | Yes |
ACW achieves early screening closure for XanaMIA trial
- pTau biomarker screening closes to new participants on October 31
- Projected total enrolment now ~240 participants (previously 220)
- Projected topline final results confirmed for mid Q4 of 2026
Actinogen Medical (ACW) is pleased to announce that due to the recent accelerated screening and enrolment in the XanaMIA phase 2b/3 Alzheimer's disease (AD) trial, the company will close pTau screening early on October 31 (previously November 30). The projected total enrolment is now ~240 participants (previously 220), with 180 participants currently enrolled and another ~60 expected to be enrolled by the end of the year. The robust enrolment in the XanaMIA trial validates the attractiveness of Xanamem as an oral, easy-to-use therapy for AD with a novel mechanism designed to control elevated brain cortisol. The trial was designed using data from the analysis of 34 AD patients from the previous XanADu phase 2 trial, which showed a large Xanamem benefit on the CDR-SB endpoint after just 12 weeks of treatment. Xanamem has also shown benefits on depressive symptoms in a recent phase 2 trial. The XanaMIA Phase 2b/3 trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in participants with mild to moderate AD and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 biomarker in blood. The primary endpoint is the internationally-recognized CDR-SB (Clinical Dementia Rating scale - Sum of Boxes). The trial is being conducted in Australia and the US, with a formal interim analysis of safety and efficacy futility to be conducted by an independent Data Monitoring Committee in late January 2026.
The accelerated enrolment in the XanaMIA trial is consistent with Actinogen's positive market research with physicians on the potential safety and efficacy advantages of oral Xanamem compared with approved Alzheimer's therapies. The company is excited to be entering the last stages of the XanaMIA trial, which will be one of two pivotal trials forming the core of its marketing applications for regulatory approvals.