Final Patient Visit Completed in Phase 2b/3 XanaMIA Trial of Xanamem in Alzheimer’s Disease; Topline Results Expected in November – Actinogen Medical

Actinogen Medical is pleased to announce that following the final trial participant visit yesterday in the USA, the Company can now confirm that topline results for the XanaMIA Phase 2b/3 Alzheimer’s disease (AD) clinical trial remain on track for November this year.

Highlights of the XanaMIA trial of oral Xanamem are:

1. Xanamem (emestedastat) is a promising, oral enzyme inhibitor designed to control elevated levels of the “stress hormone” cortisol in the brain, which are associated with the onset and progression of AD.
2. XanaMIA is designed as a randomized (1:1), double-blind, placebo-controlled pivotal trial comparing Xanamem 10 mg to placebo treatment over 36 weeks.
3. Following the randomized phase of the trial all participants may enrol in an open-label extension phase where they receive Xanamem 10 mg.
4. The trial has now completed all patient visits with 247 participants enrolled in both Australia (45%) and the US (55%).
5. Selecting participants with elevated pTau181 is a key feature of the trial, using a clinically validated blood test instead of more complex methods such as amyloid brain scans or cerebrospinal fluid biomarkers to diagnose AD.
6. Elevated pTau181 selects for participants with a more progressive disease course, increasing the trial’s power to detect a treatment effect for Xanamem over 36 weeks and replicating the diagnostic profile of the Phase 2a patient population where a large treatment benefit for Xanamem was seen (Taylor et al. 2024).
7. As reported earlier in the year, enrolled participants have baseline clinical, genetic and laboratory characteristics similar to those reported in other trials of patients with mild to moderate AD:

   a. Average age of 75 years.

   b. 49% female.

   c. 66% ApoE4 carriers (main AD genetic risk factor).

   d. Mean (SD) pTau181 2.6 (1.3) pg/mL.

   e. Mean (SD) CDR-SB 4.3 (2.0) points.

8. The trial will report topline, final results in November.

“Xanamem is a unique oral therapy with the potential to become a transformational treatment option for patients and their families living with Alzheimer’s disease. Our key focus is to finalise high-quality data from the XanaMIA pivotal trial for release in November while planning streamlined pathways to the fastest possible regulatory approvals for Xanamem.” – Dana Hilt, M.D., CMO of Actinogen Medical.