Actinogen Medical (ASX:ACW) is showcasing its lead therapy, XANAMEM (emestedastat), and the company’s advancing clinical program for Alzheimer’s disease and depression this week at BIO-Europe 2025, Europe’s largest biotechnology partnering conference.
Chief Executive Officer Dr Steven Gourlay and Chief Commercial Officer Andy Udell are representing the company in Vienna, meeting with global pharmaceutical and biotechnology leaders, investors and potential partners to discuss the pivotal XanaMIA Phase 2b/3 trial in Alzheimer’s disease and the growing global interest in novel approaches that regulate cortisol in the brain.
Actinogen’s presence follows a successful meeting with the U.S. FDA, confirming the development pathway for XANAMEM toward U.S. marketing approval and the completion of screening in the company’s pivotal Alzheimer’s trial. Interim results are expected in early 2026, with topline data anticipated mid-Q4 2026.
“We’re delighted to share our progress at BIO-Europe 2025,” said Mr Udell. “Following the FDA meeting and completion of screening in our pivotal trial, we’ve entered the final stages of development and look forward to exploring value-add regional collaborations to accelerate progress.”
XANAMEM is a once-daily oral therapy designed to inhibit the brain enzyme 11β-HSD1, which produces cortisol, a hormone linked to cognitive decline and neurodegeneration. Unlike many other approaches, XANAMEM acts within the brain without disturbing normal adrenal cortisol production. Clinical data from earlier Phase 2 studies have shown positive effects on depressive symptoms and cognitive function, reinforcing the therapy’s potential to modify disease progression.
The Alzheimer’s trial now enrolling approximately 240 patients across Australia and the U.S. is evaluating Xanamem’s ability to slow disease progression as measured by the Clinical Dementia Rating – Sum of Boxes (CDR-SB) scale. An open-label extension phase will follow in 2026 to gather long-term safety data.
Alzheimer’s disease affects an estimated 7.2 million Americans in 2025 and continues to impose growing social and economic costs. Actinogen’s approach, targeting cortisol rather than amyloid or tau, offers a differentiated pathway in a field still searching for effective disease-modifying treatments.
At BIO-Europe 2025, the company is seeking regional partners with proven commercial and regulatory experience to advance development and prepare for potential market entry following pivotal data read-outs. Discussions include customary deal structures with upfront and milestone payments and opportunities to explore additional indications such as major depressive disorder, bipolar disorder, and fragile X syndrome.