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Actinogen Medical Limited (ASX:ACW)

ALERT: Price-sensitive ASX Announcement for ACW
Current share price for ACW : $0.045 -0.01 (-18.18%)+
Announcement
Release
18 Dec 2025 8:46AM
Price at Release
$0.055
Full Release
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Summary
Actinogen Medical Limited has announced the full enrollment of 246 participants in its XanaMIA Phase 2b/3 trial for Alzheimer's disease, surpassing the initial target of 220. This double-blind, placebo-controlled trial aims to evaluate the efficacy of Xanamem, a novel treatment designed to control elevated cortisol levels in the brain, potentially slowing the progression of Alzheimer's disease. The trial's primary endpoint is the Clinical Dementia Rating scale, Sum of Boxes (CDR-SB), with topline results expected in November 2026. An interim analysis for safety and efficacy futility is scheduled for late January 2026. Additionally, an open-label extension phase will begin in Q1 2026, allowing all participants to receive active Xanamem treatment.
Key Points
  • Actinogen Medical Limited has fully enrolled 246 participants in the XanaMIA trial, exceeding the original target of 220.
  • The trial is a double-blind, placebo-controlled study for mild to moderate Alzheimer's disease, with participants receiving Xanamem or placebo.
  • Topline results from the 36-week treatment are expected in November 2026.
  • An interim analysis of safety and efficacy futility is planned for late January 2026.
  • The trial includes an open-label extension phase starting in Q1 2026, allowing all participants to receive active Xanamem.
  • Xanamem is designed to control elevated cortisol levels in the brain, potentially slowing Alzheimer's disease progression.
  • The trial is conducted in Australia and the US, with past and present participants eligible for the open-label phase.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.