Blocking the stress hormone: Phase II Alzheimer's trial underway

Actinogen Medical has recruited and treated the first patient as part of its Phase II clinical trial of Xanamem, the biotech company’s cortisol-blocking drug.

First discovered by scientists at the University of Edinburgh, Xanamem has been specifically designed to block excess production of cortisol — the stress hormone — in areas of the brain most affected by Alzheimer’s disease. Research has recently confirmed that raised cortisol levels in the blood and brain are strongly associated with the development of Alzheimer’s disease.

The link between cortisol and Alzheimer’s disease was recently highlighted in a report from the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) study, the largest research program of its kind tracking the health of more than 1100 Australians. The results of the study were published in the journal Biological Psychiatry: Cognitive Neuroscience and Neuroimaging.

Professor Colin Masters, one of the key researchers on AIBL, said Xanamem could provide the turning point needed in finding a new effective treatment for Alzheimer’s disease.

“Earlier this year the AIBL study — a 1100+ participant, nine-year study — published data showing that raised cortisol is strongly associated with the development of Alzheimer’s disease,” Professor Masters said. “Xanamem, through its inhibition of cortisol in the brain, could represent a major advance in the treatment of Alzheimer’s.”

Actinogen Medical’s first patient was treated at the Central Coast Neurosciences Research site in NSW and is part of a trial that will eventually enrol 174 patients at 20 sites across Australia, the UK and USA. The trial is said to be the largest of its kind ever conducted by an Australian biotech company.

“The evidence linking raised cortisol and the development of Alzheimer’s disease is very compelling,” said Professor Ralph Martins, another of the key researchers on ABIL. “If the results from this trial prove positive, Xanamem could be the blockbuster Alzheimer’s drug that the world has been waiting for.”

The Phase II clinical trial of Xanamem is named XanADu and registered at clinicaltrials.gov, where details including the location of study sites can be found. The final patient is expected by Q4 2018, with top-line results for the trial expected in Q1 2019.

Pictured: Actinogen Medical CEO Bill Ketelbey.