Actinogen Medical progresses in XanaMIA Phase 2b/3 trial for Alzheimer’s disease

Actinogen Medical Limited (ASX: ACW) has announced a major milestone in its ongoing XanaMIA Phase 2b/3 clinical trial, aimed at treating biomarker-positive mild to moderate Alzheimer’s disease (AD). The trial, which focuses on Actinogen’s promising drug candidate, Xanamem, has officially randomized its first participant in the United States. This development comes on the heels of significant progress in Australia, further accelerating the company’s efforts to address the global Alzheimer’s crisis.

Breakthrough in Alzheimer’s Treatment

The XanaMIA trial, currently being conducted across multiple sites in both the US and Australia, is designed to evaluate the effectiveness of Xanamem—a unique therapeutic targeting cortisol levels in the brain. The goal is to measure its impact on patients diagnosed with AD, confirmed by elevated pTau181 biomarker levels. The trial will assess Xanamem’s ability to improve cognitive function and slow disease progression over a 36-week treatment period.

Dr. Steven Gourlay, CEO of Actinogen Medical, expressed optimism about the study’s potential, stating that the opening of 10 new clinical sites in the US, alongside 15 in Australia, would accelerate patient recruitment. “The rapid enrollment at these sites will bring us closer to delivering interim results by 2025, with final outcomes anticipated by 2026,” Gourlay explained.

Phase 2b/3 Trial Design and Milestones

The XanaMIA trial is a double-blind, placebo-controlled study that will involve 220 participants, all of whom will undergo treatment with either Xanamem (10 mg daily) or a placebo. One of the study’s primary endpoints is the Clinical Dementia Rating – Sum of Boxes (CDR-SB), a globally recognized tool to measure the progression of Alzheimer’s disease. Actinogen’s previous trials involving Xanamem have shown promising results, including a significant improvement in CDR-SB scores, a key metric in Alzheimer’s research.

Secondary endpoints of the trial will include the Amsterdam Activity of Daily Living scale and a comprehensive cognitive test battery, which will provide further insights into the drug’s efficacy. An interim analysis is scheduled for Q3 2025, with final results expected in the second half of 2026.

Xanamem: A Unique Approach to Alzheimer’s Disease

Xanamem is designed to lower cortisol levels in the brain through the inhibition of the enzyme 11β-HSD1, a crucial player in the synthesis of cortisol. Elevated cortisol has long been associated with cognitive decline and neurodegenerative diseases, including Alzheimer’s. By controlling these levels, Xanamem offers a potentially revolutionary treatment option that sets it apart from other therapies currently in development.

The drug’s clinical safety profile has been favorable in prior trials, including the XanaCIDD Phase 2a study on major depressive disorder (MDD), where Xanamem demonstrated significant improvements in both depression symptoms and cognitive function.

Expert Opinion on the Trial’s Potential

Experts in Alzheimer’s research have praised Actinogen’s approach, highlighting the potential of Xanamem as a game-changer in the treatment of Alzheimer’s disease. A neurologist specializing in neurodegenerative disorders, commented, “Actinogen’s focus on cortisol regulation represents an innovative strategy to slow Alzheimer’s progression. The drug’s promising results in previous trials suggest that it could become a vital part of treatment regimens in the near future.”

The growing interest in Xanamem reflects broader trends in the Alzheimer’s research community, where novel therapies targeting neuroinflammation, protein aggregation, and now cortisol regulation, are being explored as ways to combat this debilitating disease.

A New Hope for Alzheimer’s Patients

Actinogen Medical’s latest progress in the XanaMIA Phase 2b/3 clinical trial underscores the company’s commitment to addressing the urgent need for effective Alzheimer’s treatments. With enrollment rapidly expanding, and interim results just around the corner, the future of Xanamem looks promising. If the ongoing trial delivers positive results, Xanamem could become a key player in the battle against Alzheimer’s disease, offering new hope to millions of patients worldwide.