Actinogen Medical targets Alzheimer’s treatment gap in projected $20BN market

Actinogen Medical is a biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. 

The company is currently developing its lead compound, Xanamem®, as a revolutionary new therapy for Alzheimer’s Disease, Major Depressive Disorder, Fragile X Syndrome, and other neurological diseases where reducing cortisol inside brain cells could have a positive impact.

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) earlier this week reported continued progress across its clinical, regulatory and financial programs during the June quarter, with the pivotal XanaMIA Alzheimer’s disease trial remaining on schedule to deliver topline results in November 2026.

Managing Director and CEO Dr Stephen Gourlay said the upcoming readout represented “a potentially transformational event for the company and for the clinical science, and for patients with Alzheimer’s all around the world”.

The fully enrolled Phase 2b/3 study continued treatment, follow-up and data-cleaning activities across participating sites. An independent Data Monitoring Committee also completed its third review of safety data from all 247 participants and recommended that the trial continue without amendment.

The November readout remains the company’s most significant near-term catalyst. Positive results could provide important clinical validation for Xanamem as a once-daily oral treatment for mild to moderate Alzheimer’s disease and support further regulatory and commercial activity.

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) has maintained momentum across its clinical, regulatory and commercial programs during the June quarter, with its pivotal XanaMIA Alzheimer’s disease trial on schedule to deliver topline results in November 2026.

The fully enrolled Phase 2b/3 trial continued treatment and follow-up activities across participating sites, while an independent Data Monitoring Committee completed its third review of safety data from all 247 participants and recommended the study continue without amendment. 

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) this week reported encouraging evidence that its lead drug candidate Xanamem® (emestedastat) may offer a novel treatment approach for major depressive disorder following publication of Phase 2 trial results in the peer-reviewed British Journal of Psychiatry.

The proof-of-concept study found that Xanamem demonstrated clinically meaningful antidepressant activity in patients with difficult-to-treat depression and cognitive impairment, supporting further investigation of the drug’s brain-cortisol control mechanism.

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) is approaching a defining clinical milestone as it advances Xanamem, a once-daily oral therapy designed to slow Alzheimer’s disease by controlling elevated cortisol in the brain.

The company’s fully enrolled XanaMIA Phase 2b/3 trial is expected to report topline results in November 2026, providing the most important test yet of whether Xanamem can deliver a meaningful benefit in patients with mild-to-moderate Alzheimer’s disease.

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) CEO Steven Gourlay is with Proactive’s Jonathan Jackson live from the ASX Small and Mid Cap Conference in March 2024. In a nutshell, the biotechnology company is developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. According to Actinogen, there is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long term cognitive health.

Sewell says the company is developing its lead compound, Xanamem®, as a new therapy for Alzheimer’s Disease, Major Depressive Disorder, Fragile X Syndrome and other neurological diseases where reducing cortisol inside brain cells could have a positive impact.