Alzheimer’s Trial Success Hinges on Actinogen’s Next Clinical Results
Actinogen Medical has received an additional $1.87 million R&D tax incentive rebate, bringing its total FY 2025 rebate to $7.36 million, while its Alzheimer’s phase 2b/3 trial progresses with promising safety results.
- Additional $1.87 million R&D tax rebate from ATO for FY 2025
- Total R&D rebate for FY 2025 now $7.36 million
- Positive Data Monitoring Committee review for Alzheimer’s phase 2b/3 trial
- Topline trial results expected November 2026
- Xanamem targets cortisol regulation in neurological diseases
Actinogen’s Financial Boost from R&D Incentives
Actinogen Medical Limited (ASX, ACW) has announced receipt of a further $1.87 million research and development tax incentive rebate from the Australian Tax Office, related to its overseas R&D expenditure in the 2025 financial year. This latest rebate follows an initial $5.49 million rebate received in October 2025, bringing the total R&D tax incentive rebate for FY 2025 to a substantial $7.36 million. The rebates are a critical funding source for the company as it advances its clinical programs.
Progress in Alzheimer’s Clinical Trials
The timing of this financial update coincides with encouraging clinical progress. Actinogen’s lead candidate, Xanamem, is currently being evaluated in a pivotal phase 2b/3 trial for Alzheimer’s disease, known as XanaMIA. The trial, which involves 220 patients with mild to moderate Alzheimer’s confirmed by biomarker testing, recently passed an independent Data Monitoring Committee’s safety and futility review. This positive recommendation allows the trial to continue to its planned conclusion, with topline results expected in November 2026.
Xanamem’s Novel Approach to Neurological Disease
Xanamem is a first-in-class oral therapy designed to inhibit the enzyme 11β-HSD1, reducing cortisol levels specifically within the brain. Elevated cortisol is linked to cognitive decline and neurodegeneration, making this mechanism a promising avenue for treating Alzheimer’s and other neurological and psychiatric conditions. The company has also completed a phase 2a trial in depression, which demonstrated clinically meaningful improvements in depressive symptoms, further validating the drug’s potential.
Looking Ahead
Beyond the ongoing XanaMIA trial, Actinogen plans to initiate an open-label extension study in early 2026 to further evaluate long-term safety and efficacy. The company’s ability to secure significant R&D rebates underscores the scale of its investment in innovation and supports its clinical development pipeline. Investors will be watching closely for the November trial results, which could be a pivotal moment for Actinogen’s future prospects.
Bottom Line?
With robust R&D funding and promising trial momentum, Actinogen is poised for a critical year ahead.
Questions in the middle?
- Will the November 2026 trial results confirm Xanamem’s efficacy in slowing Alzheimer’s progression?
- How will the Advanced Overseas Finding approvals impact future R&D rebate claims?
- What are the company’s plans for expanding Xanamem’s indications beyond Alzheimer’s and depression?
