XanaMIA Trial Hits 100 Participants; $13.8m R&D Funding Boosts Actinogen
Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.
- XanaMIA trial surpasses 100 enrolled participants
- Interim safety and efficacy analysis scheduled for January 2026
- $13.8 million non-dilutive R&D tax incentive funding secured
- Manufacturing scale-up batch of Xanamem completed
- Cash runway extended to mid-late 2026
Clinical Progress Accelerates
Actinogen Medical (ASX, ACW) has marked a significant advancement in its Alzheimer’s disease program, announcing that the XanaMIA phase 2b/3 clinical trial has now enrolled over 100 participants. This milestone triggers a planned interim analysis by an independent Data Monitoring Committee (DMC) set for January 2026, which will assess safety and efficacy data from patients who have completed at least 24 weeks of treatment.
The XanaMIA trial is designed to evaluate Xanamem, Actinogen’s lead compound, in patients with biomarker-positive Alzheimer’s disease, identified by elevated pTau181 levels in blood. With 123 participants enrolled as of late July and 24 more having passed screening, the trial is progressing steadily across 35 sites in the US and Australia. Full enrolment of 220 participants is expected by late 2026.
Financial Strength and Operational Readiness
Supporting this clinical momentum, Actinogen secured a $13.8 million non-dilutive funding facility backed by its FY25 and forecast FY26 Research and Development Tax Incentives. The initial $3 million tranche was drawn in the June quarter, bolstering the company’s cash position to $16.5 million and extending its operational runway into mid to late 2026.
On the manufacturing front, the company completed a 15-kilogram scale-up batch of drug substance through contract manufacturer Asymchem. This batch will be formulated into Xanamem tablets in the US for use in ongoing and future trials, a critical step toward regulatory approval and commercial readiness.
Broader Clinical and Commercial Initiatives
Beyond the XanaMIA trial, Actinogen is advancing ancillary studies including a pharmacokinetic trial in Adelaide to understand Xanamem’s absorption profile and an open-label extension trial slated for early 2026 to allow continued treatment for XanaMIA participants. The company is also actively engaging with potential partners globally, refining commercialization strategies, and strengthening intellectual property protections to safeguard Xanamem’s market potential.
Actinogen’s leadership has been visible at major international conferences, sharing promising data on Xanamem’s impact on depression and Alzheimer’s disease, underscoring the compound’s novel mechanism targeting brain cortisol regulation.
Looking Ahead
With the interim analysis approaching, investors and stakeholders will be watching closely for early signals of Xanamem’s efficacy and safety profile. The company’s strategic funding and manufacturing progress position it well to navigate the critical phases ahead, including potential partnering discussions and regulatory submissions.
Bottom Line?
As Actinogen approaches its interim data readout, the next six months will be pivotal in validating Xanamem’s potential to alter Alzheimer’s treatment paradigms.
Questions in the middle?
- Will the January interim analysis confirm Xanamem’s efficacy signals in slowing Alzheimer’s progression?
- How will Actinogen leverage its $13.8 million R&D funding to accelerate commercialization efforts?
- What are the prospects and timelines for securing partnerships to support global market entry?
