#Australia #Sydney #Alzheimer's Disease #Actinogen #XanaMIA

Actinogen Reaches Recruitment Milestone

Actinogen Medical Limited has recently announced a significant milestone in its ongoing Phase 2b/3 XanaMIA clinical trial investigating the efficacy of Xanamem®, an innovative treatment for Alzheimer's disease (AD). The trial has now reached its 100th participant, marking an important step towards the comprehensive evaluation of this potential therapy. Actinogen's commitment to addressing Alzheimer's disease through innovative treatment avenues is underscored by the timely enrollment and the forthcoming interim analysis scheduled for January 2026.

Recruitment and Interim Analysis

The enrollment of the 100th participant not only demonstrates strong recruitment efforts but also lays the groundwork for the independent Data Monitoring Committee (DMC) review in early 2026. This review will assess the safety and efficacy data collected thus far, providing critical insights into the trial's progress. By enrolling participants from 35 clinical sites, Actinogen ensures a diverse representation of patients, enhancing the validity of the trial's findings.

Dr. Steven Gourlay, Actinogen's CEO, expressed optimism about the trial's trajectory, highlighting the rigorous monitoring of Xanamem's safety throughout the trial period. He emphasized that the upcoming DMC review will contribute vital information to optimize the trial's conditions. Furthermore, the company aims to fully enroll 220 participants, establishing a comprehensive dataset to accurately evaluate the drug's performance.

Future Plans and Regulatory Pathways

The second half of 2025 is set to be a pivotal period for Actinogen as the clinical, nonclinical, and regulatory teams prepare for a Type C meeting with the U.S. FDA. This meeting will discuss potential regulatory approval pathways for Xanamem, taking into consideration data from the XanaMIA trial. The possibility of expedited pathways may also be explored, contingent upon favorable trial results. Actinogen looks to navigate these discussions effectively to facilitate the timely delivery of this promising treatment.

Understanding Xanamem's Mechanism of Action

Xanamem operates through a unique mechanism that targets cortisol levels in the brain, specifically affecting regions correlated with memory and cognitive functions. By inhibiting the enzyme 11-β-HSD1, Xanamem is designed to mitigate the detrimental effects of excess cortisol, known to harm brain cells and impair cognitive functions. Its low potential for drug interactions allows it to be potentially used alongside other existing treatments, which may enhance its therapeutic reach for Alzheimer's patients.

The Road Ahead

The next key milestones for Actinogen include:

• - H2 2025: Conducting a meeting with the FDA regarding regulatory plans.
• - Q4 2025 or January 2026: Full enrollment of participants in the XanaMIA trial.
• - January 2026: Announcement of findings from the DMC review of safety and efficacy data.
• - Q1 2026: Initiating an open-label extension trial for current and former participants of XanaMIA.
• - Q4 2026: Final results of the XanaMIA trial.

These upcoming milestones provide a roadmap for Actinogen as it advances towards a potential commercial launch of Xanamem. The company remains focused on addressing the significant unmet medical need stemming from Alzheimer's disease and other cognitive dysfunction-related conditions through innovative therapeutic approaches.

Conclusion

Actinogen's progress in the XanaMIA trial not only signifies a promising advancement in Alzheimer's research but also brings hope to patients and families affected by this demanding condition. The forthcoming interim analysis and regulatory discussions will be critical in determining the future of Xanamem as a viable treatment option, highlighting Actinogen's dedication to pioneering solutions in neurological health. As the trial continues, it reflects the unyielded commitment to advancing medical science for better cognitive health outcomes.