XanaMIA Trial Hits 247 Participants with Positive Interim Analysis Endorsement
Actinogen Medical has completed enrolment for its pivotal XanaMIA Alzheimer's trial ahead of schedule, with a positive interim analysis supporting continuation. The company is gearing up for an open-label extension and advancing commercial and partnership strategies.
- XanaMIA trial enrols 247 participants, exceeding original target
- Independent Data Monitoring Committee endorses trial continuation post-interim analysis
- Open-label extension phase to start in Q1 2026 with all participants receiving Xanamem
- Manufacturing of Xanamem tablets completed for extension phase
- Company strengthens cash position with R&D tax incentives and non-dilutive funding
Completion of Recruitment and Interim Analysis
Actinogen Medical Limited (ASX, ACW) has announced a significant milestone in its development of Xanamem, a novel oral therapy targeting Alzheimer's disease. The company successfully completed recruitment for its pivotal XanaMIA phase 2b/3 trial with 247 participants, surpassing the initial target of 220. This accelerated enrolment reflects strong engagement across 35 active sites in Australia and the United States.
Following this, an independent Data Monitoring Committee (DMC) conducted an interim analysis in January 2026 and recommended the trial continue without amendment. The DMC’s positive assessment of unblinded safety and efficacy data provides a vote of confidence in the trial’s design and progress, setting the stage for topline final results expected in November 2026.
Advancing the Open-Label Extension and Manufacturing
Looking ahead, Actinogen plans to initiate the XanaMIA open-label extension (OLE) phase in the first quarter of 2026. This phase will offer all former and current trial participants up to 25 months of active Xanamem treatment, providing valuable long-term safety and observational efficacy data. The company has completed manufacturing of the 10 mg Xanamem tablets at Catalent in the US, ensuring readiness for this next stage.
Commercial and Partnership Momentum
Beyond clinical development, Actinogen is actively refining its commercial strategy. The Chief Commercial Officer, Andy Udell, has enhanced communication materials and convened the company’s first Alzheimer’s Disease Clinical Advisory Committee, engaging nine global experts to inform clinical and commercial planning. Concurrently, discussions with potential regional and global partners are intensifying, particularly following the positive interim analysis and with final trial results on the horizon.
Financial Position and Funding Outlook
Financially, the company reported operating expenditure of $6.5 million for the quarter, primarily driven by trial activities. It received a $5.5 million R&D tax incentive rebate and repaid a $3.2 million loan secured against this rebate. Post-quarter, Actinogen secured an additional $4.3 million in non-dilutive funding from Endpoints Capital, backed by forecasted R&D rebates for FY26. Cash reserves stood at $6.5 million at quarter-end, with an estimated one quarter of funding available. The company anticipates further R&D rebates and potential capital raises to support ongoing operations.
Outlook and Regulatory Engagement
Actinogen expects to receive scientific advice from the European Medicines Agency in the second quarter of 2026, which will be pivotal for regulatory planning. CEO Dr Steven Gourlay emphasised the potential of Xanamem to become the first oral therapy to convincingly slow or stabilise Alzheimer’s decline, highlighting the importance of upcoming milestones. The company’s strategic focus on intellectual property protection and ancillary studies further underscores its commitment to advancing Xanamem’s clinical and commercial prospects.
Bottom Line?
With recruitment complete and interim data positive, Actinogen’s next challenge is delivering compelling final results and securing partnerships to propel Xanamem forward.
Questions in the middle?
- Will the final XanaMIA trial results confirm the interim analysis and demonstrate clear clinical benefit?
- How will regulatory feedback from the European Medicines Agency shape the path to market?
- What form and scale of partnerships or capital raises will Actinogen secure to sustain development and commercialisation?
